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Hepatitis B Clinical Trials

The future is bright for people with chronic hepatitis B, thanks in a large part to advancements in medical science. All drugs must go through a testing process, which involves three phases of clinical trials, to evaluate its safety and effectiveness before being approved.

Volunteering for a clinical trial program can be very valuable. Expensive blood work, treatment medications, and doctor's visits are usually provided free of charge for those accepted into a study. Clinical trials also provide the opportunity to potentially benefit from the latest advances in medical science.

The Hepatitis B Foundation regularly updates this page to provide the most current hepatitis B clinical trial sites in the United States and abroad. Please contact us if you have any questions about clinical trials or know of a drug trial that is not listed.

Click the following links for:

International HBV Clinical Trials, Co-Infection Clinical Trials, Pediatric Clinical Trials, HBV & Liver Transplantation Clinical Trials, HBV & Liver Cancer, HBV Reactivation and Lymphoma and HBV Reactivation With Other Agents


Updated June 18, 2014

U.S. CLINICAL TRIALS

*CHB=Chronic hepatitis B

Antiretroviral Pregnancy Registry – U.S. only
Multi-sponsor registry to detect any major teratogenic effect involving any of the registry drugs when administered to pregnant women. Contact: Susan Goodlow at SM_APR@INCResearch.com or call 800-258-4263 or Pam Meador at 800-258-4263 or SM_APR@INCResearch.com and refer to identifier- NCT0040989  (Study ID # APR)

Physiology of Fatigue in Patients with Chronic Liver Disease – U.S. only
Fatigue is a common, often disabling symptom in people with chronic liver disease. This study will look at the causes and mechanism of fatigue in people with chronic liver disease. Contact: Nevitt Morris, RN at nevitt.morris@nih.govor call 301-496-1665 or Dr. Yaron Rotman at 301-451-6553 rotmany@niddk.nih.govand refer to identifier- NCT01867385  (Study ID #130142, 13-DK-0142)

Tubular Function in Asian-American Patients Receiving TDF or ETV for HBV Treatment – U.S. only
Monitoring of kidney proximal tubules in HBV mono infected Asian patients receiving tenofovir treatment. Contact: Dr. C. Pan at cpan11355@yahoo.com or call 718-888-7728 or Dr. Zheng Zeng at 347-653-3178 arjason@gmail.com and refer to identifier- NCT01715987  (Study ID # BMS Al463-254)

TAF vs. TDF for the Treatment of HBeAg (+) CHB – U.S. and International
Evaluate the safety and efficacy of tenofovir alafenamide (TAF) compared to that of tenofovir disproxil fumarate (TDF) in treatment naïve and experienced adults with CHB as determined by the achievement of HBV DNA <29 IU/mL at Week 48.  Contact: Charlene Kranz at TAF4HBV@gilead.com and refer to identifier- NCT01940471 (Study ID# GS-US-320- 0110)

TAF vs. TDF for the Treatment of HBeAg (-) CHB – U.S. and International
Evaluate the safety and efficacy of tenofovir alafenamide (TAF) compared to that of tenofovir disproxil fumarate (TDF) in treatment naïve and experienced adults with CHB as determined by the achievement of HBV DNA <29 IU/mL at Week 48.  Contact: Charlene Kranz at TAF4HBV@gilead.com and refer to identifier- NCT01940341  (Study ID# GS-US-320-0108)

HBRN:  Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of CHB – U.S. and Canada
Ancillary to NIDDK-sponsored trials Combo Therapy of Pegylated interferon Alfa-2a and Tenovfovir vs. Tenofovir monotherapy in CHB (NCT01369212) and Combo Entecavir and Peginterferon Therapy in HBeAg pos immune tolerant adults with CHB (NCT01369199). Study will examine the balance between immune regulatory and effector response in CHB participants enrolled in the HBRN trials NCT01369212 and NCT01369199 to define natural history and treatment outcome.  Contact: Mary Valiga, RN 215-823-5800 ext. 6726 or mevaliga@mail.med.upenn.edu and refer to identifier NCT01796457 Study ID # DK082864 HBRN Immunology Treatment, U01DK082864

Tenofovir DF With or Without Peginterferon for CHB – U.S. only
Study to determine whether combining tenofovir DF and peginterferon or using tenofovir DF alone, and which is a more effective treatment for chronic hepatitis B. Contact: Elenita Rivera, RN at 301-496-3531 erivera@cc.nih.gov or Dr. Marc Ghany at 301-402-5115 mg228m@nih.gov and refer to identifier - NCT01821794 (Study ID # 130091, 13-DK-0091)

Withdrawal of Therapy After Long-Term Antiviral Treatment for CHB  – U.S. only
Withdrawl of therapy after long-term NAT treatment by following HBeAg pos and neg CHB patients to determine the best time to stop treatment and prevent the disease from causing further liver damage. Contact: Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. Marc Ghany at 301-402-5115 mg228m@nih.gov. Refer to identifier - NCT01581554  (Study ID#110151, 11-DK-0151)

Observational Study of Persons With Hepatitis B Virus Infection in North America – North America only
Long-term study of those with chronic HBV to improve current knowledge on the disease and long-term disease progression. Contact: Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. Marc Ghany at 301-402-5115 mg228m@nih.gov and refer to identifier - NCT01306071 (Study ID # 110108, 11-DK-0108)

Long-term Study of Liver Disease in Patients with HBV and/or HCV with or w/out HIV – U.S. only
Study to understand how these viruses affect the immune system over the long-term. Annual visit with researcher, but patient must have a primary care doctor. Contact: Colleen Kotb, RN 202-857-7652 kotbch@mail.nih.gov or Dr. Shyamasundaran Kottilil 301-435-0936 skottilil@nih.gov  Refer to identifier - NCT01350648 (Study ID # 110152, 11-CC-0152)

Evaluation of Patients With Liver Disease – U.S. only
Evaluate, investigate and follow-up patients suffering from acute and chronic liver disease. Qualified patients may be able to participate in other offered studies. Contact: Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. T. Jake Liang at 301-496-1721 jakel@mail.nih.gov. Refer to identifier - NCT00001971 (Study ID # 910214, 91-DK-0214)

Long-term Study on Anti-HBV Effect of Tenofovir (TDF) and Resistance Surveillance in Asian American Adult Patients – U.S. only
Phase IV observational study evaluating antiviral efficacy, safety, tolerability, virological response & mutations based on TDF in HBV infected Asian-Americans. Contact: Dr. C. Pan at cpan11355@yahoo.com or call 718-888-7728 and refer to identifier- NCT01267162  (Study ID # IN-US-174-0156)

Tenofovir Alone vs. Tenofovir with Emtricitabine for CHB – U.S. Only
Test whether the combination of two medications, tenofovir and emtricitabine are safer and more effective for treating CHB than tenofovir alone. Contact: Elenita Rivera, RN at 301-496-3531 erivera@cc.nih.gov or Dr. Marc Ghany at 301-402-5115 mg228m@nih.gov.and refer to identifier - NCT00524173  (Study ID# 070207, 07-DK-0207)

Combination Peginterferon and Tenofovir vs. Tenofovir in CHB (HBRN) – U.S. and Canada
Trial compares the efficacy of peginterferon plus tenofovir for 24 weeks followed by tenofovir alone for 3.5 years vs. tenofovir given alone for 4 years in CHB patients. Primary measure of outcome will be HBsAg loss at 48 weeks after stopping all antiviral therapy. Contact: Michelle Danielson, PhD at 412-624-5555 or danielsonm@edc.pitt.edu or Joan MacGregor, MS at 412-624-4300 or macgreg@edc.pitt.edu and refer to identifier - NCT01369212 (Study ID# DK082864 HBRN Immune Active)

Combination Entecavir & Peginterferon in HBeAg+, Immune Tolerant CHB Adults – U.S. and Canada
Evaluate safety and efficacy of 8 weeks of entecavir followed by combo ENT + PEG for 40 weeks, thereby hoping to gain a higher rate of HBeAg loss and viral suppression. Contact: Michelle Danielson, PhD at 412-624-5555 danielsonm@edc.pitt.edu or Joan MacGregor, MS 412-624-4300 macgreg@edc.pitt.edu and refer to identifier - NCT01369199  (Study ID# DK082864 HBRN IT Adult Trial)

Hepatitis B Research Network Adult Cohort Study (HBRN) – U.S. and Canada
A study to identify factors that cause HBV disease to activate or worsen. Contact: Michelle Danielson, PhD at 412-625-5555 or danielsonm@edc.pitt.edu or Joan MacGregor, MS 412-624-4300 at macgreg@edc.pitt.edu and refer to identifier -NCT01263587 (Study ID # DK082864, U01DK082864)

HBRN:  Immune Regulation and Costimulation in Natural History of CHB – U.S. and Canada
Ancillary to NIDDK-sponsored HBRN cohort study that will examine the balance between immune regulatory and effector response in CHB participants enrolled in the HBRN study (NCT01263587).  Contact: Mary Valiga, RN 215-823-5800 ext. 6726 or mevaliga@mail.med.upenn.edu and refer to identifier NCT01298037 Study ID # DK082864 HBRN Immunology, U01DK082864

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INTERNATIONAL CLINICAL TRIALS

*CHB=Chronic hepatitis B

TAF vs. TDF for the Treatment of HBeAg (+) CHB – U.S. and International
Evaluate the safety and efficacy of tenofovir alafenamide (TAF) compared to that of tenofovir disproxil fumarate (TDF) in treatment naïve and experienced adults with CHB as determined by the achievement of HBV DNA <29 IU/mL at Week 48.  Contact: Charlene Kranz at TAF4HBV@gilead.com and refer to identifier- NCT01940471  (Study ID# GS-US-330-0101)

TAF vs. TDF for the Treatment of HBeAg (-) CHB – U.S. and International
Evaluate the safety and efficacy of tenofovir alafenamide (TAF) compared to that of tenofovir disproxil fumarate (TDF) in treatment naïve and experienced adults with CHB as determined by the achievement of HBV DNA <29 IU/mL at Week 48.  Contact: Charlene Kranz at TAF4HBV@gilead.com and refer to identifier- NCT01940341  (Study ID# GS-US-320-0108)

HBRN:  Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of CHB – U.S. and Canada
Ancillary to NIDDK-sponsored trials Combo Therapy of Pegylated interferon Alfa-2a and Tenovfovir vs. Tenofovir monotherapy in CHB (NCT01369212) and Combo Entecavir and Peginterferon Therapy in HBeAg pos immune tolerant adults with CHB (NCT01369199). Study will examine the balance between immune regulatory and effector response in CHB participants enrolled in the HBRN trials NCT01369212 and NCT01369199 to define natural history and treatment outcome.  Contact: Mary Valiga, RN 215-823-5800 ext. 6726 or mevaliga@mail.med.upenn.edu and refer to identifier NCT01796457 Study ID # DK082864 HBRN Immunology Treatment, U01DK082864

Observational Study of Persons With Hepatitis B Virus Infection in North America – North America only
Long-term study of those with chronic HBV to improve current knowledge on the disease and long-term disease progression. Contact: Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. Marc Ghany at 301-402-5115 mg228m@nih.gov and refer to identifier - NCT01306071 (Study ID # 110108, 11-DK-0108)

Hepatitis B Research Network Adult Cohort Study (HBRN) – U.S. and Canada
A study to identify factors that cause HBV disease to activate or worsen. Contact: Michelle Danielson, PhD at 412-625-5555 or danielsonm@edc.pitt.edu or Joan MacGregor, MS 412-624-4300 at macgreg@edc.pitt.edu  and refer to identifier -NCT01263587   (Study ID # DK082864, U01DK082864)

HBRN:  Immune Regulation and Costimulation in Natural History of CHB – U.S. and Canada
Ancillary to NIDDK-sponsored HBRN cohort study that will examine the balance between immune regulatory and effector response in CHB participants enrolled in the HBRN study (NCT01263587).  Contact: Mary Valiga, RN 215-823-5800 ext. 6726 or mevaliga@mail.med.upenn.edu and refer to identifier - NCT01298037  (Study ID # DK082864 HBRN Immunology, U01DK082864)

Noninvasive Staging of Liver Fibrosis: MR vs Ultrasound – Canada
Cross-sectional study to compare sensitivity of elastographic methods for detecting histology-determined significant fibrosis. Contact: An Tang, MD MSc at 514-890-8000 ext 36400 or duotango@gmail.com  or Assia Belblidia 514-890-8000 ext 34369 at assia.belblidia.chum@ssss.gouv.qc.ca and refer to identifier -NCT02044523 (Study ID # CE12.062)

NVR 3-778 in Healthy Volunteers and Hepatitis B Patients –  International only
Phase 1 trial will assess dose-related and PK profile of different doses of NVR 3-778, first in healthy volunteers and subsequently in patients with CHB. Part II, changes in patient serum HBV DNA and other virologic efficacy parameters to be assessed. Contact: Sandy Liaw at sliaw@noviratherapeutics.com and refer to identifier- NCT02112799 (Study ID# NVR3-778-101)

Study of FG-3019 in Subjects w/Liver Fibrosis due to CHB –  International only
Randomized, double-blind, placebo controlled study to evaluate the efficacy of FG-3019 for reversing liver fibrosis in patients with chronic hepatitis B.  Contact: Mairead Carney at mcarney@fibrogen.com 415-978-1337 or Jill Magadia at jmagadia@fibrogen.com 415-978-1340 and refer to identifier- NCT01217632 (Study ID# FGCL-3019-801)

Collect Biomarker Samples From CHB Patients Who Received TX w/ Pegasys in +/- Nucleos(t)ide Analogs – International only
Collect blood biomarkers samples from patients who have completed CHB treatment with at least 25 weeks of Pegasys plus at least 24 weeks post treatment follow-up. Contact: www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (US only) and refer to Study ID # GV28855. Identifier -NCT01855997 (Study ID # GV28855)

Telbivudine or Tenofovir Treatment in HBeAg (-) CHB Patients based on Roadmap Concept (LDT600A) – International only
Evaluate efficacy and safety following Roadmap Concept – initial monotherapy with Telbivudine or tenofovir in HBeAg (-) CHB patients. Contact:  Novartis Pharmaceuticals at +41-61-324-1111 and refer to identifier NCT01379508 (Study ID # CLDT600A2409)

Safety and Efficacy of PEG-Intron vs. PEGASYS in Patient with CHB – International only
Compare the safety and efficacy of PEG-intron to that of PEGASYS in participants with CHB who have not been previously treated with interferon. Contact:  Call toll free at 1-888-577-8839 Refer to identifier – NCT01641926 (Study ID #P08450, MK-4031-376)

Pegylated Interferon and Entecavir Combination in CHB – Bangladesh only
Assess whether the combination of PEG and entecavir offer the best outcome to treatment naïve CHB patients in terms of virological and biochemical response, TX cost, duration and adverse events. Contact:  Dr. Mamun Mahtab  at +880 171-156-7275 shwapnil@agni.com or Helal Uddin, BSc, DPH at +8801819251514 or bhc@dhaka.net  Refer to identifier – NCT01589952  (Study ID # BB1)

Traditional Chinese Medicine Diagnosis and Treatment Blocking and Reversing HBV Related Fibrosis – China  
Randomized, controlled, double-blind, multi-center trial evaluating optional TCM diagnosis and treatment of HBV liver related fibrosis. Contact: Yongping Yang, Master at 0086-13601371542 or yongpingyang@hotmail.com.  Refer to identifier - NCT01965418 (Study ID # 2013ZX10005002)

Evaluating Hepatic Fibrosis Related to Hepatitis B Virus Using Non-invasive Parameters – China  
Prospective study used to construct and validate a non-invasive model consisting of biochemical markers, FibroScan, and radiological parameters for evaluating liver fibrosis as a result of HBV. Contact: Guiqiang Wang at 13911405123 or john131212@126.com or Hong Zhao at 13810765943, minmin2001@gmail.com.  Refer to identifier - NCT01962155 (Study ID # 2013ZX10002005)

Optimized Treatment and Regression of HBV-Induced Compensated Liver Cirrhosis – China  
Patients with HBV induced compensated liver cirrhosis will participate in a study to evaluate entecavir alone, entecavir + thymosin-alpha, for varying durations, etc. Assessed at baseline and every 6 months. Contact: Dr. Hong You at 8610-63139019 or youhong30@sina.com or Dr. Jidong Jia at 8610-63139816, jiamd@263.net.  Refer to identifier - NCT01943617 (Study ID # 2013ZX10002004-3)

Optimized Treatment and Regression of HBV-Induced Early Cirrhosis – China Patients with chronic HBV histologically confirmed with early cirrhosis are randomized in a 1:1 ratio, multi-armed study – entecavir alone, entecavir + thymosin-alpha for varying durations, etc. Assessed at baseline and every 6 months. Contact: Dr. Hong You at 8610-63139019 or youhong30@sina.com or Dr. Jidong Jia at 8610-63139816, jiamd@263.net.  Refer to identifier - NCT01938820 (Study ID # 2013ZX10002004-2)

Optimized Treatment and Regression of HBV-Induced Liver Fibrosis – China
Patients with chronic HBV histologically confirmed of liver fibrosis are randomized in a 1:1 ratio, multi-armed study – entecavir, entecavir + thymosin-alpha for varying durations, etc. Assessed at baseline and every 6 months. Contact: Dr. Hong You at 8610-63139019 or youhong30@sina.com or Dr. Jidong Jia at 8610-63139816, jiamd@263.net.  Refer to identifier - NCT01938781 (Study ID # 2013ZX10002004-1)

3E Extension Study – China
Long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced HBV patients. Contact: Dr. Jinlin Hou at 86-20-61641941 or jlhousmu@yahoo.com.cn  Refer to identifier - NCT01834508 (Study ID # MOH-07)

Peginterferon Alfa-2b in HBeAg (+) Patients with CHB – China
Efficacy and safety of Peginterferon alfa-2b in chronic hepatitis patients. Contact: Please refer to site locations and email inquiries to clinical@amoytop.com and refer to identifier - NCT01760122 (Study ID # TB1211IFN)

Combo or Sequential Therapy of Peginterferon Alfa-2a and Entecavir for Patients with CHB – China
Investigate efficacy of combination or sequential therapy using Peginterferon Alfa-2a and entecavir in HBeAg positive chronic hepatitis B patients. Contact: Dr. Sa Lv at 86-10-63879735 ext 2014.12 or lvsa@sina.com and refer to identifier - NCT01906580 (Study ID # 2011030D)

Treatment with HBIG+GM-CSF+HBV Vaccine for CHB Patients with HBeAg Seroconversion – China
Immunotherapy including hepatitis B immune globulin (HBIG), plus ganulocyte-macrophage colony stimulating factor (GM-CSF) plus HBV vaccine to enhance anti-HBV immune responses and improve HBsAg serconversion in CHB patients who have achieved HBeAg seroconversion using nucleoside analog treatment. Contact: Dr. Fu-Sheng Wang at 86-10-63879735 or fswang302@163.com and refer to identifier - NCT01878565  (Study ID # Beijing302-009)

Clinical Effects and Cost-effectiveness Analysis of Early Antiviral Therapy on HBV-related Compensated Liver Cirrhosis – China
Investigate clinical effects and cost-effectiveness of two early antiviral strategies (Entecavir or Lamivudine plus Adefovir) on HBV related compensated liver cirrhosis through prospective, open-label, multicenter, nonrandomized study. Contact: Dr. Dong Ji Jia at 86-10-63139816 or jiamd@263.net, or Dr. Hong You at 86-10-63139019 or youhong30@sina.com  and refer to identifier - NCT01720238  (Study ID # D12110000039120003)

Efficacy Optimizing Extension Study of CHB Patients with Inadequate Response to NUC Therapy (Dragon-Ex) – China
Study to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy. Contact: Dr. Jinlin Hou  at 86-20-61641941 or jhousmu@yahoo.com.cn, or Jian Sun at 86-20-62787432 or sunjian@fimmu.com  and refer to identifier - NCT01829685  (Study ID # MOH-06)

Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV Related Cirrhosis – China
Patients with HBV related cirrhosis will undergo administration of human hUC-MSC via hepatic artery to evaluate safety and efficacy for the patient. Contact:  Ying Han at 86-29-84771539 or Hanying@fmmu.edu.cn or Yongquan Shi at 86-29-84771515 shiyquan@fmmu.edu.cn and refer to identifier - NCT01728727  (Study ID # 20120912-3) 

Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV Related Liver Cirrhosis – China
Patients with HBV related cirrhosis will undergo administration of human autologous PBSCs via hepatic artery to evaluate safety and efficacy for the patient. Contact:  Ying Han at 86-29-84771539 or Hanying@fmmu.edu.cn or Yongquan Shi at 86-29-84771515 shiyquan@fmmu.edu.cn and refer to identifier - NCT01728688  (Study ID # 20120912-2) 

Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV Related Cirrhosis – China
Patients with HBV related cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to evaluate safety and efficacy for the patient. Contact:  Ying Han at 86-29-84771539 or Hanying@fmmu.edu.cn or Yongquan Shi at 86-29-84771515 shiyquan@fmmu.edu.cn and refer to identifier - NCT01724697  (Study ID # 20120912-1) 

Effectiveness of Nucleos(t)ide Analog Therapy (NUC) Among Naïve CHB Patients – China
Compare effectiveness of Entecavir monotherapy and Lamivudine based therapies among chronic hepatitis B patients who are naïve to NUC at enrollment. Contact:  For information please email individual site. First line of email MUST contain NCT# & Site#  Refer to identifier - NCT01726439  (Study ID # AI463-952) 

Study of Pegasys in Chinese Patients With HBeAg Neg. CHB – China
Evaluate efficacy and safety of Pegasys (peginteferon alfa-2a) in HBeAg neg. CHB Chinese patients. Contact: Reference Study ID # ML28516 at www.roche.com/about_roche/roche_worldwide.htm or 888-662-6728 (US only) global.rochegenentechtrials@roche.com. Identifier - NCT01730508 (Study ID # ML28516)

Study in Noninvasive Evaluation of Hepatic Fibrosis in CHB – China
Evaluate liver fibrosis using biochemical markers, FibroScan, and radiology methods in patients with CHB. Contact: Dr. Hong Zhao at 13810765943 or minmin2001@gmail.com or Dr. Guiqiang Wang at 13911405123 or john131212@126.com and refer to identifier - NCT01679769 (Study ID # 2012-455, 81170386)

Telbivudine Therapy in HBeAg+ Pregnant Women to Prevent Mother to Infant Transmission of HBV – China
Study to determine whether telbivudine among HBsAg+ and HBeAg+ pregnant women during the 3rd trimester, in addition to immunoprophylaxis in infants is more effective than standard immunoprophylaxis in preventing HBV infections in infants. Contact: Dr. Yi-Hua Zhou at +86 25 8330 4616 ext 10373 yzh2006111@yahoo.com  or Dr. Yali Hu at +86 25 8330 4616 ext 66808 dtylhu@126.com and refer to identifier – NCT01637844  (Study ID # 2012019)

Tenofovir in Late Pregnancy to Prevent Vertical Transmission of HBV – China
Evaluate tolerability, safety, and efficacy of reduction of HBV vertical transmission rate using Tenofovir, a pregnancy category B medication, on HBeAg+ pregnant women . Contact: Dr. Calvin Pan at +01-7188887728  cpan11355@yahoo.com  or Dr. Frank Huang at +86-13533051208 frankhuangyujun@gmail.com and refer to identifier - NCT01488526  (Study ID # IN-US 174-0174)

EFFORT Extension Study (EFFORT-Ex) – China
Prove that long-term efficacy of strategy of TX adjustment at week 24 according to virological response based on ROADMAP is better than the standard care strategy and the evaluation of off-treatment durability of HBeAg seroconversion in patients who discontinued TX due to sustained HBeAg seroconversion and HBV DNA<300 cp/ml over 12 months consolidation TX.  Contact: Dr. Jinlin Hou  at 86-20-61641941 or jhousmu@yahoo.com.cn, or Jian Sun at 86-20-62787432 or sunjian@fimmu.com  and refer to identifier - NCT01529255  (Study ID # MOH-05)

A Two-Year Study of Telbivudine in HBeAg Negative Hepatitis (STEN) – China
ROADMAP strategy provides individualized telbivudine treatment for HBeAg neg CHB patients, where telbivudine is given, but may include adding adefovir based on patient’s response. Contact: Dr. Chao-Shuang Lin at 0086(020)85252110 or linchaoshuang@yahoo.com.cn  and refer to identifier - NCT01521975  (Study ID # HBeAg negative Roadmap)

Efficacy and Safety of Dual-Plasmid Hepatitis B Virus DNA Vaccine in CHB – China
Double blind, randomized, placebo controlled trial to study immunotherapeutic effects of EP mediated dual-plasmids HBV vaccine on CHB patients with ALT 2X ULN, with antiviral treatment indicated. Contact:  Dr. Fuqiang Yang at 00862087376240 or yangfq23@163.com and refer to identifier - NCT01487876  (Study ID # 2011005SW0101)

HBsAg Clearance in Inactive Chronic HBsAg Carriers After Interferon Treated – China
Investigate PEG-IFN ability to achieve HBsAg loss/seroconversion in inactive carriers with persistently normal ALT, undetectable DNA and low surface antigen levels. Contact: Dr. Yao Xie  at +8610-84322489 or xieyao@public.bta.net.cnand refer to identifier - NCT01471535  (Study ID # DTH-XY002)

Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With CHB Infection– China
Patients are divided into two groups: early and conventional. Patients are followed for 10 yrs. to determine optimal start time for TX.  Contact: Dr. Gao Zhiliang at +862085252037, zhanlianh@21cn.com or Dr. Huang Zhanlian at +8685252046, Zhanlianh@21cn.com and refer to identifier - NCT00810524  (Study ID # Sun Yat-senU 5010 Hepatitis  B)

Efficacy and Safety of Telbivudine on Liver Cirrhosis in Patients with CHB – China
Antiviral treatment of CHB patients with liver cirrhosis using telbivudine. Contact: Honghao Zhang at zhanghonghao@medmail.com.cn and refer to identifier - NCT01380951  (Study ID # szwy20110610)

Influence of Hepatic Steatosis on Entecavir in CHB Patients – China
Investigate the influence of hepatic steatosis on the anti-viral effect of entecavir in CHB patients.  Contact: Dr. Xi Jin at 0086-571-87266532 or jxfl007@hotmail.com and refer to identifier -NCT01148576  (Study ID # NCTZJU201001)

Early Response to Interferon Combined with Short-Term Nucleoside Analogue Therapy in HBeAg (+) CHBChina
Interferon is used for 12 weeks at which time if HBV DNA is undetectable (<1000 copies/ml), it is continued alone for one year. If HBV DNA is still positive, nucleoside analogue is added for 3 months. After 3 months if HBV DNA is undetectable, stop nucleoside analogue and use interferon alone for another 6 months or longer. If HBV DNA is still positive, change to another nucleoside analogue or add another nucleoside analogue. Contact: Dr. Huang Zhanlian at +86 013 58 05 84031 or email zhanlianh@21cn.com  Refer to identifier - NCT00860626 (Study ID # interferonshorttermnucleoside)

Liver Fibrosis Prevalence in France –France
Cohorts in France will assess the prevalence of fibrosis and specific risks of fibrosis progression in patients with viral hepatitis, NAFLD and ALD. Contact: Thierry Poynard at 00 33  1 42 16 10 22 tpoynard@teaser.fr  or Vlad Ratziu at 00 33 1 42 16 10 02 or vratziu@teaser.fr and refer to identifier - NCT01927133  (Study ID # DRCD2013-01 )

Therapeutic Option for Hepatitis B and C:  A French Cohort –France
Cohort will integrate clinical, genetic, pharmacogenomics, environmental, biomarkers and behavioral data in a large number of patients and will aid with cross-disciplinary and translational research on viral hepatitis and estimate relative effects of treatments and further cost-effectiveness studies. Contact: Dr. Fabrice Carrat at  +33144738458 stanislas.pol@jussieu.fr  or Dr. Celine Dorival at +33144738668 or dorival@jussieu.fr  and refer to identifier - NCT01953458  (Study ID # ANRS CO22 HEPATHER, 2011-A01438-33 )

Prevention of Hepatitis B Vertical Transmission by Serovaccination and Tenofovir During Pregnancy –France
The risk of vertical transmission is related to HBV DNA in pregnant women, with around 30% in women with HBV DNA above 1,000,000 IU/mL despite serovaccination of newborns. This study will look at using Tenofovir during the last trimester of pregnancy to reduce the transmission risk.  Contact: Dr. Pierre O Sellier at 00 33  55 149956339 pierre.sellier@lrb.aphp.fr and refer to identifier - NCT02039362  (Study ID # Liver002 )

Real-life Cohort of Patients With CHB Infection –France Constitute a “real-life” cohort of non-selected patients to create a database of epidemiological, clinical, biological, virological, and therapeutic parameters to determine factors associated with the outcome of CHB.  Contact: Dr. Francois Habersetzer at +33(0) 3 69 55 10 09 francois.habersetzer@chru-strasbourg.fr and refer to identifier - NCT01732081  (Study ID # 5452)

PROLIFICA – West African Treatment Cohort for Hepatitis B (WATCH) – Gambia
 This European Commission Funded FP7 project aims to determine whether screening for HBV using a point of care test is feasible and effective. Secondly is to monitor linkage from screening to care. Third is to evaluate cheap noninvasive assessment. Fourth is to determine patients eligible for treatment. Fifth is to establish a TX cohort that can measure adherence to therapy and avoidance of HBV related complications. Contact: Mark R Thursz, MD FRCP at 0207 886 6454 m.thursz@imperial.ac.uk or Maud N Lemoine, MD PhD at 0207 886 6454 m.lemoine@imperial.ac.uk  hwasmuth@ukaachen.de Identifier - NCT02129829  (Study ID # WMDH-P34114)

Induction of Fibrosis Regression on Patients with CHB )INFIRE) – Germany
Study will examine whether 12 months treatment with entecavir has an effect on changes of liver stiffness measurement and of hyaluronan measurement in patients with chronic HBV. Contact: Dr. Hermann Wasmuth at +49 241 80 ext 80861 hwasmuth@ukaachen.de Identifier - NCT01341106  (Study ID # CTC-A 11-018m 2010-019884-12, 11-018)

Peg-Interferon ADDed to Ongoing Nucleos(t)ide Based Treatment in Patients W/ CHB to Induce Decrease in HBsAg– Germany
Randomized, open-label phase IIb trial assessing effect of pegysys once weekly for 48 weeks added to ongoing nuclos(t)ide tx in patients with HBe negative CHB. Contact: Dr. Peter R Galle  at +49 6131 17  ext 7275 peter.galle@unimedizin-mainz.de or Dr. Annette Grambihler at +49 6131 17 ext 6075 annette.grambihler@unimedizin-mainz.de  and refer to identifier - NCT01524679  (Study ID #ML 27787)

Patients With CHB and Low Viremia Not Receiving Antiviral Therapy– Germany
An observational long-term study to evaluate demographic, clinical, histological, biochemical, and virological parameters of CHB patients with low viremia, not requiring antiviral therapy.  Contact: Dr. Christoph Sarrazin at +496301 ext 5122 sarrazin@em.uni-frankfurt.de  and refer to identifier - NCT01090531  (Study ID # JWGUHMED1-002)

Study of ARC-520 in Patients with Chronic Hepatitis B – Hong Kong
Multicenter, randomized, double-blind, placebo-controlled, dose escalation study to determine the depth and duration of HBsAg reduction after a single intravenous dose of ARC-520 in combination with entecavir in CHB patients. Contact: Winnie Leung at +852 9646 3894  Winnie.Leung@iconplc.com  or Diamond Martin at +1 626 696 4704 dmartin@arrowres.com and refer to identifier - NCT02065336  (Study ID # Heparc-2001)

48-Week Peginterferon Alfa-2a (PEGASYS) to Assess the Sustained Response of CHB Patients with HBeAg Serconversion on NU Therapy – Hong Kong
Multicenter, single-arm, open-label on virologicial response of chronic HBV infection to pegyinterferon-alfa-2a among patients who achieved HBeAg seroconversion on nucleot(s)ide analog treatment and to investigate the sustained response. Contact: Angel ML Chim, MSc at +852 2632 4205 angelchim@cuhk.edu.hk  and refer to identifier - NCT02068365  (Study ID # ML28486)

Combined TDF Plus Telbivudine vs. TDF Alone in Patients with Spontaneous Reactivation of HBV – India
Compare the efficacy of combined Tenofovir (TDF) plus Telbivudine versus Tenofovir alone in patients with spontaneous reactivation of HBV. Contact: Dr. Ankur Jindal at 9582670984, ankur.jindal3@gmail.com. Refer to identifier - NCT01732224 (Study ID # ILBS-HBV Reactivation-01)

Randomized Controlled Study of Tenofovir Plus Telbivudine vs. Monotherapy with either drug in HBeAg (-) CHB patients – India
Determine efficacy and safety of combination therapy of tenofovir plus telbivudine vs. monotherapy with either drug. Contact: Dr. Manoj Kumar at +91-11-64659881, manojkumardm@gmail.com , or Dr. Tarandeep Singh at +91-11-64659881, drtarandeep@gmail.com  Refer to identifier - NCT01260610 (Study ID # CLDT600AIN05T)

Beneficial Effect of Vitamin D Supplement to PEG IFN or Telbivudine Monotherapy in CHB Patients– Israel
The impact of Vitamin D, an important immune-modulator, has on virologic response of patients undergoing peg or nucleotide analog therapy. Contact: Dr. Assy Nimer at +97246828445 or ASSY.N@ZIV.HEALTH.GOV.IL and refer to identifier - NCT01083251(Study ID #004-10)

Sonazoid Enhanced Liver Cancer Trial For Early Detection– Japan
Use of contrast enhanced ultrasound (US) using Sonazoid vs. conventional B-mode US for early HCC detection.  Contact: Masatoshi Kudo at +81 72-366-0221 ext. 3149 or m-kudo@med.kindai.ac.jp, or Dr. Kazuomi Ueshima at +81-72-366-0221 ext. 3525, kaz-ues@med.kindai.ac.jp and refer to identifier – NCT00822991 (Study ID# JLOG08001, UMIN000001612)

Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease– Japan
Multi-center cross-sectional study using Real-time Tissue Elastography measurements prospectively from HBV/HCV patients presenting for liver biopsy. Contact: Dr. Norihisa Yada at +81 72366-0221 ext. 3525 or yada@med.kindai.ac.jp, or Dr. Kazuomi Ueshima at +81-72-366-0221 ext. 3525, kaz-ues@med.kindi.ac.jp and refer to identifier -NCT01360879 (Study ID# JLOG1002)

Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastopgraphy– Japan
Multi-center cohort study using Real-time Tissue Elastography measurements to predict the incidence of HCC and severity of ascites & decompensated cirrhosis in HBV/HCV patients. Contact: Dr. Norihisa Yada at +81 72366-0221 ext. 3525 or yada@med.kindai.ac.jp, or Dr. Kazuomi Ueshima at +81-72-366-0221 ext. 3525, kaz-ues@med.kindai.ac.jp and refer to identifier - NCT01360892(Study ID# JLOG1003)

Therapeutic Vaccination with Intensified Schedule Plus Pegasys Dual Therapy on CHB Infection– Korea
Compare efficacy and safety of therapeutic vaccination with intensified schedule plus Pegylated Interferon dual therapy on seroclearance of HBsAg in Patients with complete virological response induced by Entecavir. Contact: Dr. Yoon Jun Kim at yoonjun@snu.ac.kr or call 82 2 745 1721 or Dr. Yun Bin Lee yubin@hanmail.net  and refer to identifier – NCT02097004  (Study ID # E+VIP)

Association Insulin Resistance and Hepatic Fibrosis in CHB and NAFLD– Korea
The aim is to investigate the relationship between insulin resistance, hepatic steatosis and fibrosis in patients with chronic hepatitis B. Contact: Dr. Won Kim at drwon1@snu.ac.kr  or call 8228702233 or Dr. Saekyung Joo joo.sammy@gmail.com 821089619285 and refer to identifier – NCT02031913  (Study ID # HBV_FL)

Phase 3 Study of Besifovir– Korea
Prove that a study drug is noninferior to a control drug with a proportion of subjects who showed HBV DNA undetected after 48 weeks of Besifovir, or Tenofovir as a control drug to CHB patients. Contact: Se-Eun Kim, Master at trpv1@ildong.com  or call 82(0) 526-3518 or Gayou Hong, Bechelor gyhong@ildong.com 82(0)2 526 3519 and refer to identifier – NCT01937806  (Study ID # ID_BVCL011)

Switching to Tenofovir vs Continuing Entecavir in CHB Patients w/ Partial Virologic Response During Entecavir TX (STEEP) – Korea
Compare the efficacy of switching to tenofovir with continuing entecavir in chronic HBV patients who show partial virologic response to entecavir. Contact: Dr. Hyung Joon Yim at gudwns21@medimail.co.kr  or call 82-31-412-5583 or Dr. Sang Jun Suh mothpickle@naver.com 82-31-412-4926 and refer to identifier – NCT01711567  (Study ID # STEEP study)

Baracle Tab. vs. Baraclude Tab. for Patients with HBeAg CHB – Korea
Double blind, active-controlled, randomized, parallel study to demonstrate antiviral activity and safety of Baracle Tab and Baraclude Tab for patients with HBeAg chronic HBV. Contact: Dr. Han Chu Lee at +82-2-3010-7166 irb@amc.seoul.kr Refer to identifier – NCT01913431  (Study ID # ETV_HB_IV)

Comparison of Telbivudine + Adefovir  (ADV) with LAM + ADV for the Treatment of Lamivudine Resistant CHB at 52 Weeks (TeSLA)– Korea
Evaluate safety and efficacy of telbivudine plus adefovir compared with lamivudine plus adefovir in lamivudine resistant chronic hepatitis B patients at the end of 1 year follow-up. Contact: Dr. Hyung Joon Yim gudwns21@medimail.co.kr at 82-31-412-5583 and refer to identifier – NCT01804387 (Study ID #TeSLA study)

HBsAg Related Response Guided Therapy (S-RGT) – Korea
Compare Pegasys RGT overall response (ex. HBeAg seroconversion rate) with Pegasys mono historical response rate at week 72, and to track the change in HBsAg titers. Contact: Kwansik Lee, Professor  at +82-11-9636-9935 or leeks519@yuhs.ac and refer to identifier – NCT01456312 (Study ID #ML25588)

Telbivudine Versus Entecavir in Reducing Serum HBsAg Levels in HBeAg+ CHB – Korea
Investigate whether telbivudine is more effective in inducing HBsAg decline compared with entecavir in HBeAg+ CHB patients who have achieved undetectable HBV DNA suppression with preceding entecavir tx.  Contact: Dr. Young-Suk Lim limys@amc.seoul.kr or 82-2-3010-5933 and refer to identifier – NCT01595685 (Study ID #AMC2012-0201)

Switch from ADV to TDF in CHB for Suboptimal Resp. to ADV Combo Therapy – Korea Evaluate efficacy, safety & tolerability of switching from adefovir to tenofovir in CHB patients who have suboptimal response to ADV-based combo rescue therapy due to resistance. Contact: Dr. BeomKyung Kim beomkkim@yuhs.ac or 82-2-2228-1930 or Dr. Jun Yong Park at 82-2-2228-1994 DRPJY@yuhs.ac and refer to identifier – NCT01595633 (Study ID #4-2011-0937)

Observational Cohort Study for Durability of antiviral TX in CHB Patients – Korea
Investigate the off-treatment sustained virological and biochemical response in chronic hepatitis B patients following the guidelines by Asia Pacific Assn. for Study of the Liver (APASL) in Korea. Contact: Dr. Hana Park at PHN223@yuhs.ac or call 02-2228-1931 and refer to identifier – NCT01533051  (Study ID # Quit Anti-viral therapy)

Efficacy of Telbivudine W/ or W/out Add-on Tenofovir Compared With Tenofovir – Korea
Compare antiviral effect and mutation rate between entecavir monotherapy group and telbivudine roadmap strategy in HBeAg+ CHB patients. Contact: Dr. Ki Tae Yoon at ktyoon@pusan.ac.kr  or call 82-55-360-2362  or Surin Tak surintak@hanmail.net 82-55-360-1738 and refer to identifier – NCT01588912  (Study ID # CLDT600AKR07T)

Cohort Study in Korean Patients With CHB Receiving Pegylated Interferon – Korea
Evaluation of CHB patients with genotype C on Pegasys and the durability of HBeAg seroconversion/HBsAg loss and effect on long term disease progression. Contact: Dr. Young Eun Chon at NACHIVYS@yuhs.ac  or call 02-2228-1936 and refer to identifier - NCT01531166 (Study ID # 4-2011-0461)

Study of Sequential Therapy of Pegasys following Entecavir in CHB – Korea
Evaluate safety and efficacy of PEG-IFN following Entecavir vs. PEG-IFN monotherapy in HBeAg (+) patients. Contact: Joo Hyun Sohn at +82-31-560-2225 sonjh@hanyang.ac.kr or Dae-Won Jun at +82-2-2290-8338 noshin@hanyang.ac.kr  Refer to identifier – NCT01220596  (Study ID # ML25206)

Evaluate Efficacy and Safety of Clevudine and pegIFN in Sequence vs. Clevudine Alone or Clevudine and pegIFN Sequential in HBeAg (+) CHB Patients – Korea
Evaluate efficacy and safety of Clevudine + peg-IFN in sequence vs. Clevudine alone in CHB HBeAg(+) patients. Contact: Dr. Lee Chang Don at +82-31-820-3000 and refer identifier – NCT01264367  (Study ID # CMC-403)

Lamivudine plus Adefovir vs. Telbivudine plus Adefovir in Lamivudine Resistant CHB  – Korea
Compare efficacy of continuing LAM + ADV vs. switching to Telbivudine + ADV in patients with poor response to LAM + ADV. Contact: Dr. Han Jak Ryu at +82-10-2329-2379 or hanjak@yuhs.ac or Dr. Jun Yong Park at +82-2-2228-1994 or DRPJY@yuhs.ac , and refer to identifier-NCT01270165  (Study ID # Sebivio-Ahn-01)

Development of Diagnostic Biomarker Panels for Hepatitis B and Liver Cancer  – Malaysia
Develop biological markers that could be indicators for disease-inducing and carcinogenic potential of the virus. Contact: Clinical Research Centre at +603-404-39300 ext. 113 shanthini@crc.gov.my and refer to identifier - NCT01310062  (Study ID # 09-317-3991)

PEG-Interferon Alfa-2a Add-On Study in HBeAg Neg CHB (PAS) – Netherlands
Investigate if addition of PEG-IFN alfa-2a in HBeAg (-) chronic hepatitis B patients who are pretreated with nucleos(t)ide analogs enhances the HBsAg decline. Contact:  Dr. H.L.A Janssen at +14166035800 ext 2776 harry.janssen@uhn.ca or Dr. M.J.H. Van Campenhout at +31107034513 or m.vancampenhout@erasmusmc.nl and refer to identifier - NCT01373684  (Study ID # HBV 11-01)

Genetic Study of Peginterferon Treatment in CHB Patients: (GIANT-B) – Netherlands
Collect clinical and virological data on CHB patients previously treated with Peg-IFN to see if IL28B gene polymorphisms are associated with response to PEG IFN therapy. Contact:  Dr. Willem Pieter Brouwer w.p.brouwer@erasmusmc.nl, +31107033042 and refer to identifier - NCT01401400  (Study ID # HBV-10-03)

Cohort of Hepatitis B Research of Amsterdam – Netherlands
Observational cohort study to determine whether historic HBV viral load is associated with the risk of HBV related cirrhosis or mortality in a cohort of non-Asian individuals with CHB. Contact Dr. Soeradj Harkisoen at +31 88 7556228  or s.harkisoen@umcutrecht.nl and refer to identifier - NCT01462981  (Study ID # COBRA)

HBsAg Loss in CHB Patients with Low Viral Load – Netherlands
Investigate proportion of HBeAg negative, inactive carriers (DNA < 20K IU/ml) who will lose HBsAg when treated with PEG +Adefovir, or PEG + Tenofovir. Contact Dr. Henk Reesink at +31 20 5662787 or h.w.reesink@amc.nl, or Dr. Annikki de Niet at +31 20 5668278 a.deniet@amc.nl and refer to identifier - NCT00973219  (Study ID # TTM16002, ABR no.: 28338)

Study to Assess DV-601 in Subjects with CHB – Poland
Determine if DV-601, a therapeutic vaccine, will be well tolerated and induce virological and immunological response in CHB patients. Contact: Dr. K. Majorowski at +48 22 544 1756 or kmajorowski@grs-cro.com and refer to identifier – NCT01023230  (Study ID # DV4-HBT-02, 2009-010142-66)

Real Time Elastography in Liver Fibrosis– Romania
Aim to evaluate the role of real time elastography (ARFI and Hitachi elastography) in noninvasive diagnosis of liver fibrosis in patients with chronic hepatitis.  Contact: Dr. Larisa Sandulescu at +40723968354 orlarisasandulescu@yahoo.comand refer to identifier – NCT01948687  (Study ID # RT-ELASTO)

PROLIFICA – West African Treatment Cohort for Hepatitis B (WATCH) – Senegal   This European Commission Funded FP7 project aims to determine whether screening for HBV using a point of care test is feasible and effective. Secondly is to monitor linkage from screening to care. Third is to evaluate cheap noninvasive assessment. Fourth is to determine patients eligible for treatment. Fifth is to establish a TX cohort that can measure adherence to therapy and avoidance of HBV related complications. Contact: Mark R Thursz, MD FRCP at 0207 886 6454 m.thursz@imperial.ac.uk or Maud N Lemoine, MD PhD at 0207 886 6454 m.lemoine@imperial.ac.uk  hwasmuth@ukaachen.de Identifier - NCT02129829  (Study ID # WMDH-P34114)

Define HBsAg Loss w/ or w/out Seroconversion to antiHBs in Patients w/ CHB Treated with NA – Spain
Define the patients who lost HBsAg, studying the loss predictive factors, and if there was suspension of treatment, study the evolution after that. Contact: Emilio Suarez Garcia at 955 01 50 00 or Maria del Mar Benjumea Vargas at gestionensayosclinicos.fps@juntadeandalucia.es , and refer to identifier – NCT02005146  (Study ID # ESG-HEP-2013-01)

Efficacy of Switching or Adding Peginterferon in CHB Patients on Long Term Antivirals (SWAP)  – Singapore
Evaluate whether switching or adding peginterferon compared to continuing antiviral is a more efficacious strategy. Contact: Dr. Seng Gee Lim at mdclimsg@nus.edu.sg and refer to identifier – NCT01928511  (Study ID # MK4031-398 CIRG12may075)

TDF vs LAM for Patients with CHB with Severe Acute Exacerbation (HBSAE) – Taiwan
Evaluate the use of tenofovir versus lamivudine for patients with chronic HBV experiencing a severe acute exacerbation, and which is most effective. Contact: Dr. Wei-Lun Tsai at 886-7-3422121 ext 2075 or tsaiwl@yahoo.com.tw, or Dr. Hoi-Hung Chnan 886-7-3422121 ext 2074 hhchan@vghks.gov.tw, and refer to identifier – NCT01848743  (Study ID # Gilead IN-US-174-0190)

Pegasys Plus Entecavir vs. Entecavir vs. Pegasys HBeAg (-) CHB – Taiwan
Evaluate combination therapy of Pegasys followed by entecavir monotherapy versus Entecavir monotherapy or Pegasys monotherapy for HBeAg negative, chronic HBV patients. Contact: Dr. Pei-Jer Chen at 886-2-231-23456 ext 67072 or peijerchen@ntu.edu.tw, or Chun-Jer Liu 886-2-23-123456 ext 67503 cjliu@ntu.edu.tw , and refer to identifier – NCT01925820  (Study ID # 201205003MPC)

Comparison Between Lamivudine and Entecavir Treatment in Patients (NUC115132) –Taiwan
Prospective, observational, open-label, 2-arm parallel, multi-center study where patients with HBV associated severe acute exacerbation for whom treatment with NRTI (such as lamivudine and entecavir) are medically recommended, enrolled and followed. Contact: Dr. Sheng-Shun Yang +886-4-23592525 ext 3309 or email yansh@vghtc.gov.tw or Dr. Teng-Yu Lee at +866-4-23592525 ext 3301 or tylee@vghtc.gov.tw and refer to identifier NCT01627223 (Study ID # NUC115132)

HBV DNA Levels During Pregnancy in Chronic Hepatitis B –Taiwan
Elucidate the natural course of chronic HBV by serial HBV DNA and ALT levels during pregnancy. Contact: Mei-Hsia Ku +886-3-3281200 ext 8114, email kuvicky1029@gmail.com or Yi-Cheng Chen at 866-3-3281200 ext, 8107 yichengliver@gmail.com and refer to identifier - NCT01610115  (Study ID # HBV-P-01)

Tenofovir in Chronic Hepatitis B With Mild ALT Elevation –Taiwan
Clarify whether CHB patients with high viral load will benefit from oral anti-viral therapy despite only mildly elevated serum liver enzymes. Contact: Dr. Jaw-Town Lin +886-2-23123456 ext 62246 or email jawtown@ntu.edu.tw  or Dr. Yao-Chun Hsu at +866-7-6150011 ext 2980 or gatsbyhsu@yahoo.com.tw and refer to identifier NCT01522625 (Study ID # EMRP36100N)

Acoustic Radiation Force Impulse (ARFI) Technology in Prediction of Liver Fibrosis –Taiwan
Complete correlation and validity studies for liver fibrosis staging between ARFI elastosonography quantification and METAVIR by liver biopsy in CHB patients.  Contact: Dr. Sheng-Hung Chen 886-4-22052121 ext 2264 shcvghtc@gmail.com and refer to identifier NCT01268865 (Study ID # DMR99-IRB-240)

Switch to Tenofovir vs. Continue LAM/ADV TX in LAM-Resistant CHB Patients –Taiwan
Study to evaluate the efficacy of switching to TDF monotherapy from LAM/ADV combo in patients with LAM-resistance in chronic HBV. Contact: Dr. Yi-Hsiang Huang +886-2-28712121 ext 3055 or email yhhuang@vghtpe.gov.tw and refer to identifier NCT01491295 (Study ID # IN-IS-174-0194)

Study of Telbivudine in CHB –Taiwan
Evaluate the safety, tolerability and antiviral efficacy of telbivudine by maintained suppression of HBV DNA (<=60 IU/ml) in HBeAg (+)/(-) patients at physician’s general practice. Contact: Hsiang-min Kung +886-3-3281200 ext 2224 or email hsiang0721@gmail.com and refer to identifier NCT00970216 (Study ID # PMST-Y-1)

Prednisolone Priming Study in Patients with CHB –Taiwan
Investigate whether ALT rebound following corticosteroid priming enhances response to telbivudine therapy. Contact: Mei-Hsia Ku +886-3-3281200 ext 8114 or email kuvicky1029@gmail.com and refer to identifier - NCT00778596  (Study ID # CST-L-1)

Pegasys Plus Entecavir vs. Entecavir only for HBeAg (+) CHB – Taiwan
Evaluate combo therapy of Pegasys plus Entecavir vs. Entecavir alone for HBeAg (+) CHB Patients. Contact: Dr. Pei-Jer Chen at 886-2-231-23456 ext 7072 or peijerchen@ntu.edu.tw, or Chun-Jen Liu 886-2-23-123456 ext 6644 cjliu@ntu.edu.tw , and refer to identifier – NCT00597259  (Study ID # 200710028M)

Entecavir with Pegasys Sequential Therapy vs. Pegasys for HBeAg (+) CHB –Taiwan
A placebo controlled randomized study to evaluate if adding entecavir early in the course of therapy or extending the treatment duration of peginterferon alfa-2a can improve the treatment response. National Taiwan University Hospital: Contact Dr. Chen-Hua Liu at 886-2-23123456 ext 63572 jacque_liu@mail2000.com.tw or Dr. Jia-Horng Kao at 886-2-23123456 ext. 67307 kaojh@ntu.edu.tw and refer to identifier - NCT00921180  (Study ID # 950922)

Entecavir with Pegasys Sequential Therapy vs. Pegasys for HBeAg (-) CHB –Taiwan
A placebo controlled randomized study to evaluate if adding entecavir early in the course of therapy or extending the treatment duration of peginterferon alfa-2a can improve the treatment response for HBeAg (-) patients.  Contact Dr. Chen-Hua Liu at 886-2-23123456 ext 63572 jacque_liu@mail2000.com.tw or Dr. Jia-Horng Kao at 886-2-23123456 ext. 67307 kaojh@ntu.edu.tw and refer to identifier – NCT00917761  (Study ID # 950924)

Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B (iTAP) –Thailand
Pregnant women who are HBV infected will receive tenofovir or placebo during the last trimester of pregnancy and 2 months postpartum and perinatal transmission will be compared. Contact Dr. Gonzague Jourdain at  +66818830065 Gonzague.Jourdain@ird.fr or Dr. Nicole Ngo-Giang-Huong at +6625347306 Nicole.Ngo-Giang-Huong@ird.fr and refer to identifier NCT01745822  (Study ID # U01HD071889)

PEG-IFN Monotherapy vs. Combination with Entecavir in HBeAg (-) CHB –Thailand
Determine if combination of PEG-IFN and entecavir improves response and HBsAg clearance in HBeAg (-) patients vs. PEG-IFN alone. Contact Dr. Pisit Tangkijvanichan  +662-256-4482 pisittkvn@yahoo.com and refer to identifier NCT01243281  (Study ID # Biochem2010/01)

ST-2 Non-Invasive Fibrosis Marker for CHB – Turkey
IL-33 is a recently identified number of the IL-1 family. Hepatic over-expression of IL-33 has recently been linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. Aim is to determine ability of ST2 to predict fibrosis in CHB. Contact Dr. Ismail H Kalkan +90 312 437 67 78 drismailster@gmail.com and refer to identifier NCT01633554  (Study ID # 24190708 Ikalkan24190708)

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HBV CO-INFECTION TRIALS

*CHB=Chronic hepatitis B

Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa –Zambia only
Establish a cohort of patients starting antiviretroviral therapy with chronic HBV and study the effect of CHB on HIV and liver related outcomes according to the ART regimen and site. Contact: Dr. Michael Vinikoor at 260 966921285 or Michael.vinikoor@cidrz.org  to identifier NCT02060162 (Study ID # 12-2568)

Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in HIV-1/CHB Co-infected Adults – U.S. only
Safety, efficacy and tolerability of a single tablet regimen containing Elvitegravir, Cobicisistat, Emtricitabine, tenofovir and Alafenamide in HIV-1/HBV co-infected adults through 48 weeks. Contact: Mark Lopez at 650-372-4456 or marc.lopez@gilead.com  Refer to identifier NCT02071082 (Study ID # GS-US-292-1249)

Hepatic Safety of Currently Used Antiretroviral Regimens in Patients w/CHB –Spain only
Compare liver toxicity in HIV infected patients w/ CHB and/or CHC, who start a new antiretroviral therapy drug regimen, as well as the influence of the degree of existing liver fibrosis on the incidence of liver toxicity. Contact: Karin Neukam, PhD at 0034955015871 karin.neukam@gmail.com or Jose A Mira-Escarti, MD at 0034955015684 miraescarti@yahoo.es  Refer to identifier NCT01908660 (Study ID # SEG-HEP-2007)

Safety Study of Tenofovir-containing Drug Regimen for Prevention of Mother to Child Transmission of HIV and HBV –China only
Compare regimen of tenofovir/lamivudine/lopinavir-ritonavir to the WHO recommended regimen of zidovudine/lamivudine/lopinavir-ritonavir during 2nd & 3rd trimesters in HIV/HBV coinfected pregnant women. Contact: Sascha Ellington, MSPH 770-488-6037 or sellington@cdc.gov and refer to identifier NCT01125696 (Study ID # CDC 5877)

Lonafarnib for Chronic Hepatitis D –U.S. only
Study different doses of lonafarnib for those coinfected with HBV and HDV to see how it affects virus levels and other symptoms of HDV. Contact: Vanessa Haynes-Williams, RN at 301-402-0267 vhaynes@mail.nih.gov or Dr. Theo Heller at 301-402-7147 theoh@intra.niddk.nih.gov   Refer to identifier NCT01495585 (Study ID # 120046, 12-DK-0046)

Long-term Study of Liver Disease in Patients with HBV and/or HCV with or w/out HIV – U.S. only
Study to understand how these viruses affect the immune system over the long-term. Annual visit with researcher, but patient must have a primary care doctor. Contact: Colleen Kotb, RN 202-857-7652, kotbch@mail.nih.gov or Dr. Shyamasundaran Kottilil at 301-435-0936 skottilil@niaid.nih.gov . Refer to identifier - NCT01350648 (Study ID # 110152, 11-CC-0152)

Innate Immunity in HIV Positive Patients co-Infected with HCV or HBV –Australia
Data from this study will provide the first information on how the innate immune system may be altered in HIV-HCV and HIV-HBV co-infected individuals, and describe Toll-like receptor changes with HIV co-infection therapy. Contact: Jennifer Audsley, PhD (Monash University) at jennifer.audsley@med.monash.edu.au (Refer to identifier -NCT00662194 (Study ID # ALF-55/08)

Surveillance Program for the Detection of HBV Resistance to Tenofovir in HIV-HBV Co-Infected Patients –Australia
Identify any changes in the HBV DNA that might be associated with resistance to tenofovir (TDF), to determine how long any changes take to occur and to determine the effect of these changes on the clinical response to TDF in HIV-HBV co-infected patients. Contact Jennifer Audsley, PhD at +61399030184 or jennifer.audsley@med.monash.edu.au (Refer to identifier - NCT00660361) (Study ID # ALF-55/08)

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PEDIATRIC HBV CLINICAL TRIALS

*CHB=Chronic hepatitis B

Non-invasive Biomarkers of Fibrosis in Pediatric Viral Hepatitis –U.S. only
This study is being conducted to develop new techniques for early diagnosis of liver disease. These include Shearwave Elastography (SWE) ultrasound and blood biomarkers. Contact:  Jameisha Brown, BS at 832-824-3813, Jameisha.brown@bcm.edu or Dr. Daniel H Leung at dhleung@texaschildrens.org , 832-822-3606 and refer to identifier – NCT01988753 (Study ID # H-30472)

Pediatric Hepatitis B Research Network Study (HBRN) – U.S. and Canada
An NIH-funded study for children between 6 months and < 18 yrs. with HBV infection in a prospective cohort to identify predictors of disease activation and progression. Contact:  Refer to contacts at individual locations by identifier – NCT01263600 (Study ID # DK082864Pediatric, U01DK082864.) Please click for HBRN details for parents and details for pediatric providers.

Tenofovir DF in Pediatric Patients With Chronic Hepatitis B –U.S. and International
Placebo-controlled study evaluates efficacy, safety and tolerability of tenofovir in patients 2 to < 12 years old with CHB. Contact:  Yvonne Walker at yvonne.walker@gilead.com and refer to identifier – NCT01651403 (Study ID # GS-US-174-0144)

Study of Pegysys vs. Untreated Control in Children With HBeAg+ CHB – U.S. and International.
Evaluate safety and effectiveness of Pegysys vs. untreated control in kids age 3 to <18 yrs at baseline with HBeAg+ CHB. Assignments will be based on fibrosis/cirrhosis status. Contact:www.roche.com/about_roche/roche_worldwide.htm or 888-662-6728 (US only) global.rochegenentechtrials@roche.com and refer to Study ID # YV25718. Identifier – NCT01519960 (Study ID # YV25718, 2011-002732-70)

Entecavir/Pegylated Interferon in Immune Tolerant CHB Children – U.S. and Canada. Determine effectiveness of combination drug treatment with entecavir and pegylated interferon vs. no treatment in children ages 3-<18 who have immune tolerant CHB. Contact:  Michelle Danielson, PhD at 412-624-5555, danielsonm@edc.pitt.edu Joan MacGregor, MS at 412-624-4300 macgreg@edc.pitt.edu and refer to identifier – NCT01368497 (Study ID # DK082864 HBRN IT Peds Trial.) Please click for trial details for parents and Health Care Provider details.

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HBV AND LIVER TRANSPLANTATION CLINICAL TRIALS

*CHB=Chronic hepatitis B

Prophylaxis of HBV recurrence after Liver Transplantation -China
Evaluate Entecavir + HBIG vs. Lamivudine + HBIG vs. Adefovir + HBIG in HBV Transplant Patients. Contact: Dr. Zhi-Hai Peng at 0086-021-63240090 ext 3132 or pengpzh@hotmail.com or Dr. Tao Li 0086-021-63240090 ext. 3136 transplant@126.com and refer to identifier – NCT01139203 (Study ID # SH20100601)

Prevention of HBV Reinfection Post Liver Transplant via Entecavir -Germany
Determine if HBIG can be stopped early and replaced with Entecavir following HBV-induced liver transplantation to prevent reinfection. Contact: Dr. M. Manns at +495115320 ext 3305 or manns.michael@mh-hannover.de and refer to identifier – NCT01046799 (Study ID # 2008-005976-28)

Niuliva® for the Prevention of HBV Recurrence in Orthotopic Liver Transplant Recipients– Italy
Evaluate efficacy & safety of HBV immune globulin in the prophylaxis of HBV reinfection of HBV liver recipients, maintaining HBsAb levels for first six months post-transplant. Contact: Antonio Paez, MD at +34 935710700 or antonio.paez@grifols.com, or Michael Woodward at +34 935710700 mwoodward@grifols.com and refer to identifier - NCT01131065 (Study ID # IG 0907)

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HBV AND LIVER CANCER (or HEPATOCELLUAR CARCINOMA, HCC)

*CHB=Chronic hepatitis B

G-202 as Second-Line Therapy Following Sorafenib in Hepatocellular Carcinoma – U.S. only
Evaluate activity and safety of G-202 in patients with HCC who have progressed after taking sorafenib and will be administered by IV infusion. Contact: Please see contact information for individual sites and refer to identifier – NCT01777594 (Study ID # G-202-003)

Sorafenib + mFOLFOX for Hepatocellular Carcinoma (HCC) – U.S. only 
In this study, sorafenib,the standard, is being combined with modified FOLFOX. Contact: Daniel Harris at 617-726-8478 and refer to identifier - NCT01775501 (Study ID#: 12-218).

SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC) – U.S. only 
A Phase 2 Study of SGI-110 in the treatment of advanced hepatocellular carcinoma for patients who failed prior treatment with Sorafenib. Contact: Medplace Recruitment Center at 1-866-872-2349 and refer to identifier - NCT01752933 (Study ID#: SGI-110-03).

Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area – U.S. only
Patients between the age of 18 & 90 who have been diagnosed with HCC or have a high risk of developing HCC due to HBV, HCV, fatty liver disease, etc. Contact: Dr. Xin Wang at 301-496-2099 or xw3u@nih.gov and refer to identifier – NCT00913757 (Study ID # 999909149, 09-C-N149)

Multiple Antigen Specific Cell Therapy (MASCT) for HCC Patients After Radical Resection or Radio Frequency Ablation – China
To prove the efficacy and safety of MASCT group is superior to non-treatment group in patients undergone curative resection (RFA or operation) for hepatocellular carcinoma. Contact: Peggy Chen, Master at 00860755-86964231 orchenping@thyx.com and refer to identifier – NCT02026362 (Study ID # SYZ Cell Therapy Co.)

Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery – China
Sustained CHB virus inflammation is a major cause of liver cancer occurrence and development. Antiviral treatment can block persistent infection. Aspirin can limit liver cell necrosis and inflammation and can inhibit metastasis.  Contact: Dr. Zheng-Gang Ren at 0086-021-64041990 ext 2149, ren.zhenggang@zs-hospital.sh.cn or Dr. Lan Zhang 0086-021-64041990 ext 2971 zhang.lan@zs-hospital.sh.cn and refer to identifier – NCT01936233) (Study ID # LC-ASPIRIN, ASPIRIN-13-08)

Impact of Hypersplenism and Splenectomy on Hepatocarcinogenesis in Patients with Posthepatic Cirrhosis – China
Investigate impact of splenectomy coupled w/ portal-azygous disconnection on hepatocarcinogenesis in patients with post-hepatic cirrhosis after HBV or HCV infection. Contact: Prof. Chen Yong at 13891915509 or cheny@fmmuedu.cn and refer to identifier – NCT01201655 (Study ID # chenyong)

Risk of Exacerbation of CHB after Percutaneous Radiofrequency Ablation of HCC – China
Risk of exacerbation of CHB after RAF or hepatomy for HCC and effects on treatment outcome. Contact: Dr. Min-Shan Chen at 86-20-87343117 or Chminsh@mail.sysu.edu.cn and refer to identifier – NCT00720668 (Study ID # RFA006)

Efficacy of Antiviral Therapy After Radical Resection for HBV-related HCC – China
Antiviral treatment with Lamivudine or Entecavir following radical resection of HBV-related HCC.  Contact: Dr. Xiang-Ming Lao at 86-20-87343115 or laoxming@mail.sysu.edu.cn and refer to identifier – NCT00768157) (Study ID # SYSUCC-HCC004)

HCC Treatment Using Transcatheter Arterial Chemoembolization (TACE) with Anti-HBV Therapy (TACEHBV)  –China 
Influence of anti-HBV therapy (Telbivudine) on safety and survival of HCC patients after TACE.  Contact: Dr. Jinglin Xia at xia.jinglin@zs-hospital.sh.cn or Dr. Biwei Yang at yang.biwei@zs-hospital.sh.cn and refer to identifier – NCT01102335 (Study ID # LCI-001)

TACE and Adefovir Compared with Transcatheter Arterial Chemoembolization (TACE) Alone for HBV Related Unresectable HCC  –China 
Influence of TACE plus adefovir vs. TACE alone on those CHB patients with unresectable HCC. Contact: Dr. Daoyuan Wang +86 21 6630058 ghealth2008@gmail.com and refer to identifier – NCT00960518 (Study ID # SHDSYY20090725)

A Randomized Study Comparing Lamivudine vs. Adefovir for Prevention of HBV Reactivation in HBsAg+ Patients on Chemo  –Hong Kong
Open label study for HBsAg (+) patients undergoing chemotherapy to receive lamivudine or adefovir during TX. Contact: Dr. Chee-Kin Hui at 852-2818 4300 ckh23@hku.hk and refer to identifier – NCT00489151 (Study ID # UW 04-315 T/637, HARECCTR0500002)

Dose Escalation Study for Japanese Patients with HCC – Japan
Investigate the safety, tolerability, efficacy and PK for Japanese HCC patients who are not amenable to curative surgery or loco regional therapy.  Contact: Boehringer Ingelheim Call Center at 1-800-243-0127 or clintriage.rdg@boehringer-ingelheim.com and refer to identifier – NCT01594125 (Study ID # 200906051R)

Hypofractionated Proton Beam Radiotherapy for HCC – Korea
Phase II study to evaluate effectiveness of hypofractionated proton Beam therapy for HCC patients in HBV endemic areas.  Contact: Dr. Tae Hyun Kim at +82-31-920-1725 or k2onco@ncc.re.kr and refer to identifier – NCT01643824 (Study ID # 200906051R)

Tenofovir Antiviral Therapy Following Transarterial Chemoembolization for HBV Related HCC – Taiwan
Study to evaluate the impact of tenfovir for hepatocellular carcinoma patients who underwent TACE, to evaluate if there are improved outcomes. Contact: Dr. Chun-Ying Wu at 886-4-23592525 ext 3304 or chun@vghtc.gov.tw , or Dr. Teng-Yu Lee at 886-4-23592525 ext 3316 or tengyulee@gmail.com  and refer to identifier – NCT01872988  (Study ID # CF12045, JIRB11-036-A)

Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Evaluation Liver Functional Status & TX Efficacy in Patients with HCC After Locoregional Therapy – Taiwan
Recruiting patients referred for TACE w/ newly diagnosed, unresectable HCC or tumor reoccurrence and patients treated with RFA as a control group. Contact: Dr. Tiffany Ting-Fany Shih at 886-2-23123456 ext. 65568 or ttfshih@ntu.edu.tw and refer to identifier – NCT01281683 (Study ID # 201010059R)

Dose Escalation Trial of Radiation Therapy (RT) for HCC – Taiwan
Determine max. tolerated dose of RT, and evaluate tumor control, patterns of failure and survival for those HBV carriers with HCC.  Contact: Dr. Jason Chia-Hsien Cheng at 886-2-23123456 ext. 66696 or jasoncheng@ntu.edu.tw and refer to identifier – NCT00960167 (Study ID # 200906051R)

TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma – China only
Determine if TACE plus Recombinant Human Adenovirus Type 5 Injection will improve outcome in patients with advanced HCC not amenable to surgery or local ablative therapy. Contact: Dr. Ming Shi at 86-2087343582 ext 86-2087343582 shiming@mail.sysu.edu.cn or Dr. Rong Ping Guo 86-2087343117 ext 86-2087343117 guorongp@mail.sysu.edu.cn and refer to identifier - NCT01869088 (Study ID # HCC-120402)

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HBV REACTIVATION AND LYMPHOMA

*CHB=Chronic hepatitis B

Entecavir vs. Lamivudine for Preventing the Risk of HBV Reactivation in NHL – China only
Prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B reactivation in patients with non-Hodgkin Lymphoma on CHOP/R-CHOP. Contact: Dr. Ye Guo +86 21 64175590 ext 8906 pattrick_guo@msn.com and refer to identifier – NCT01914744 (Study ID # LMTG 13-03)

Prophylactic Use of Entecavir for HBsAg (+) Lymphoma Patients with Rituximab based Immunochemotherapy – China only
Identify the effect of prophylactic entecavir in HBsAg positive lymphoma patients treated with rituximab-based immunochemotherapy and or chemotherapy.    Contact: Jun Zhu at zj@bjcancer.org or Yuq NCT01462981 in Song at songyuqin622@sina.com and refer to identifier – NCT01768195 (Study ID # PKU-2012111304)

Prophylactic Use of Entecavir for HBsAg (-)/HBcAb (+)/Hepatitis B Virus DNA (-) with Lymphoma – China only
Identify the effect of prophylactic entecavir in HBsAg negative/HBcAb positive/hepatitis B virus DNA negative patients with lymphoma.  Contact: Jun Zhu at zj@bjcancer.org or Yuqin Song at songyuqin622@sina.com and refer to identifier – – NCT01765231 (Study ID # PKU-2012111305)

Activation of HBV in HBsAg (-) But Anti-HBc Postive Patients – Japan only
Observational study to determine risk factors and strategies for individuals with resolved HBV (HBsAg (-) and Anti-HBc) and malignancy. Contact: Dr. Yoshihide Ueda at 81-75-751-3111 yueda@kuhp.kyoto-u.ac.jp  and refer to identifier NCT00881036 (Study ID # HBV from anti-HBc positive)

Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: ENT vs. LAM – Korea only
Compare the effect of entecavir (ENT) versus lamivudine (LAM) to prove the superiority of entecavir over lamivudine for the prevention of reactivation of HBV in HBsAg positive patients undergoing cytotoxic chemotherapy. Contact: Dr. Sook-Hyang Jeong +82 31 787-7034 jsh@snubh.org and refer to identifier – NCT01580202 (Study ID # Al463-246)

HBV REACTIVATION WITH OTHER AGENTS

*CHB=Chronic hepatitis B

Widespread vs. Selective Screening for Hepatitis B Infection Prior to Chemotherapy – U.S. only
Goal is to learn about testing patients for viral infections prior to chemotherapy. Contact: Dr. Jessica P. Hwang at 713-745-4516 and refer to identifier – NCT01970254 (Study ID # 2012-0961, 1R21CA147202-01A1)

Antiviral Prophylaxis for HBsAg(+),or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFαKorea
Analysis of effect of anti-TNF treatment on HBV reactivation among patients with systemic rheumatic disease, especially rheumatoid arthritis. Contact: Dr. Kichul Shin at 82-2-870-3198 kideb1@snu.ac.kr and refer to identifier – NCT01694264 (Study ID # H-1112-073-390)

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Page last modified June 18, 2014


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