Clinical Trials
Clinical trials are research studies that test new potential treatments for a disease. Talk to your doctor about clinical trials that could possibly be helpful to you.
Clinical Trial Finder - Find A Clinical Trial Near You!
Glossary: HBV = Hepatitis B Virus, CHB = Chronic Hepatitis B, HDV = Hepatitis D Virus, CHD = Chronic Hepatitis D, ALT = Alanine aminotransferase, AST = Aspartate aminotransferase, EOT = End of Treatment, NTCP = Sodium/taurocholate co-transporting polypeptide, LNF-containing regimens = Lonafarnib-containing regimens, PEG-IFN = Pegylated Interferon
Available: Replicor Compassionate Access Program - International
The goal of this compassionate access program is to provide early access to REP 2139-Mg for patients with HBV mono-infection or HBV / HDV co-infection who either have advanced (decompensated) cirrhosis or who have failed to respond to other other antiviral agents either approved or under development and who are in danger of progressing to decompensated cirrhosis. This compassionate access program will provide access to a once weekly regimen of subcutaneously (SC) administered REP 2139-Mg for a period of 48 weeks with the goal of achieving a functional cure of HDV and/or HBV, with the reversal of liver disease in the absence of antiviral therapy. The safety, tolerability and efficacy of SC REP 2139-Mg will be monitored during and after therapy. Contact Andrew Vaillant at +1514.733.1998 or availlant@replicor.com OR Michel Bazinet at +1514.733.1998 or mbazinet@replicor.com and refer to identifier NCT05683548.
Currently recruiting participants in:
- Austria, France, Italy, Israel, Turkey
Recruiting: Study of Bulevirtide in Participants with Chronic Hepatitis D Infection - International
The main goal of this study is to collect post-marketing data from patients with chronic hepatitis D virus (HDV) infection who are treated with bulevirtide (BLV) to describe the long-term effects of BLV treatment and evaluate the safety of participants treated with BLV. This is an observational study and no treatment will be offered to participants. Contact Gilead Clinical Study Information Center at +1-833-445-3230 (GILEAD-0) or GileadClinicalTrials@gilead.com and refer to identifier NCT05718700.
Currently recruiting participants in:
- Austria
- Germany
- France
- Romania
- Spain
Recruiting: Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function - U.S.
The goals of this Phase 1 study are to measure the amount of bulevirtide (BLV) that gets into the blood stream and how long it takes to get rid of it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal and impaired hepatic (liver) function. Contact Gilead Clinical Study Information Center at + 1-833-445-3230 (GILEAD-0) or GileadClinicalTrials@gilead.com and refer to identifier NCT05765344.
Currently recruiting participants in:
United States
- California, Florida, Texas
Recruiting: A Multiple Dose Study of Bulevirtide in Participants with Normal and Impaired Renal Function - U.S.
The goals of this Phase 1 study are to compare the amount of study drug, bulevirtide (BLV), that gets into the bloodstream and how long it takes for the body to eliminate it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal or impaired renal (kidney) function. Contact Gilead Clinical Study Information Center at +1.833.445.3230 (GILEAD-0) or GileadClinicalTrials@gilead.com and refer to identifier NCT05760300.
Currently recruiting participants in:
United States
- Florida, Massachusetts, Minnesota
Recruiting: Improvement of Portal Hypertension During Viral Suppression in Patients with Hepatitis Delta (IMPHROVE-D) - International
Portal hypertension (PH) is one of the key drivers of clinical deterioration in patients with liver cirrhosis. It has been demonstrated that antiviral therapy in patients with chronic hepatitis C infection leads to a decrease of PH and is associated with an improved outcome. Recently, bulevirtide (BLV) was approved for the treatment of patients coinfected with hepatitis B (HBV) and chronic hepatitis delta (HDV) infection, and helps to achieve viral suppression in these patients. This study investigates the potential effects of viral suppression from BLV on portal hypertension in participants with chronic HBV/HDV infection and liver cirrhosis. Contact Benjamin Maasoumy at +49511 532 6529 or Maasoumy.Benjamin@mh-hannover.de or Tammo L Tergast at tergast.tammo@mh-hannover.de for more information and refer to identifier NCT04863703.
Currently recruiting participants in:
- Germany (Hannover)
This is a prospective, multicentric, non-comparative study, with a retrospective data collection aiming at evaluating the efficacy and safety of bulevirtide in participants with chronic HBV/HDV co-infection with severe fibrosis injuries, or moderate fibrosis injuries associated with persistent increase of ALT. This is an observational study and no treatment will be offered to participants. Contact Fatoumata Coulibaly at +331 44 23 61 10/fatoumata.coulibaly@anrs.fr or Claire Fougerou-Leurent at claire.fougerou@chu-rennes.fr and refer to identifier NCT04166266.
Currently recruiting participants in:
- France
Recruiting: Disease Loads and Status of Treatment - International
The aim of this study is to evaluate the current prevalence of HDV infection and comprehensively analyze the interaction between HDV and HBV infections in the era of antiviral therapies in Taiwan. This is an observational study and no treatment will be offered to participants. Contact Chun-Jen Liu at +88697265107 or
cjliu@ntu.edu.tw and refer to identifier NCT05264272.
Currently recruiting participants in:
- Taipei City, Taiwan
Recruiting: Evaluation of Patients with Liver Disease, Including Hepatitis Delta – U.S.
This study aims to evaluate, investigate and follow-up with patients suffering from acute and chronic liver disease. Patients participating in the study will first undergo a routine check-up as an outpatient. They will be asked to provide blood and urine samples for laboratory testing and will undergo an ultrasound of the liver. Ultrasound examinations use sound waves to determine the size and texture of the liver. After the initial visit, participants will be requested to follow up once a year at the outpatient department for a similar check-up. Additional tests may be requested throughout the study to provide information for other research studies and individual consent will be requested. These tests may include liver biopsies, skin biopsies, and/or specialized blood, plasma, and lymphocyte examinations. Participants that qualify for medications presently being studied may be offered the opportunity to benefit from experimental therapy. This is an observational study and no treatment will be offered to participants. Contact Patricia E. Alcivar at 301.435.6121/patricia.alcivar@nih.gov or Dr. T. Jake Liang at 301.496.1721 or jakel@mail.nih.gov and refer to identifier NCT00001971.
Currently recruiting participants in:
- United States - Bethesda, Maryland (National Institutes of Health)
Recruiting: SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection - International
This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy. Contact 415-654-5281 or clinicaltrials@vir.bio and refer to identifier NCT05461170.
Currently recruiting participants in:
- New Zealand
- United Kingdom
- Romania
- Moldova
- Bulgaria
- France
- Germany
- Italy
- Netherlands
Recruiting: Burden of Hepatitis D Virus (HDV) Infection in Italy (HDV DESCRIBE) - International
This project intends to establish the contemporary epidemiological and medical context of HDV in immigrants in Italy and to determine the clinical characteristics and needs of the residual cohort of native HDV Italians, through the analysis of all HDV cases recruited in 12 months in a coordinated network of 35 Italian medical centers. The data will provide an appraisal of the burden of hepatitis D in the country and of its impact on the National Health System. They will present the paradigm of the current trend of HDV infection in high-income countries in the world. This is an observational study and does not offer any treatment. Contact Gian Paolo Caviglia at +39 0116333532 or gianpaolo.caviglia@unito.it OR Gabriella Zaccone at +39 0116709626 or gabriella.zaccone@unito.it and refer to identifier NCT05723068.
Currently recruiting participants in:
- Italy
Recruiting: Thailand HDV Cohort - International
This study plans to perform a nationwide survey of the prevalence and predictors of HDV among people who use drugs (PWUD) with and without HIV, among MSM and non-MSM who are coinfected with HBV and HIV, and among those living with HBV-related cirrhosis. Findings from this study will provide the scientific community with an understanding of how important HDV is among HBV patients, information which in turn could be used to develop strategies for HDV screening and treatment. This is an observational study and no treatment will be offered to participants. Contact Chatsuda Auchieng at 6626523040 ext 118 or chatsuda.a@hivnat.org or Pirapon J Ohata at 6626523040 ext 147 or juneohata4@gmail.com and refer to identifier NCT05350865.
Currently recruiting participants in:
- Thailand (Bangkok)
Recruiting: DELTA DESCRIBE: The French Collaborative Project - International
This study's objective is to draw up a photograph of HDV patients over one year in metropolitan France and identify the barriers of screening and care. The investigator suspects a mismatch between HBV and HDV screening, which is the first step for specialized care pathway in metropolitan France. This is an observational study and no treatment will be offered to participants. Contact Sandra Juge at 0555056414, x33 or sandra.juge@chu-limoges.fr or Celine Rigaud at celine.rigaud@chu-limoges.fr and refer to identifier NCT05936073.
Currently recruiting participants in:
- France (Limoges)
The aim of this study is to assess the efficacy and specific safety in an observational study of patients with chronic hepatitis D (CHD) with prospective follow-up, with antiviral treatment of 2 mg Bulevirtide (BLV) +/- PEG-IFNα-2a and +/- nucleos(t)ide analog (NA) given as part of the patient's routine medical care. Also, explorative endpoints of biomarkers in peripheral blood, saliva, fecal sample and/or intrahepatic markers/signatures, and quality of life outcomes will be assessed. This is an observational study and does not offer any treatment. Contact Dr. Soo Aleman at +46 72-595 72 25 or soo.aleman@regionstockholm.se and refer to identifier NCT06051045.
Currently recruiting participants in:
- Sweden (Stockholm)
This study aims to assess the efficacy and safety of bulevirtide (BLV) in chronic hepatitis D patients treated in Greek liver centers. This is an observational study and does not offer any treatment. Contact Dr. George Papatheodoridis at +306946330639 or gepapath@med.uoa.gr OR Spyridoula Kardara at 00302107231332 or info@eligast.gr and refer to identifier NCT05928000.
Currently recruiting participants in:
- Greece (Athens)
Recruiting: A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects with Chronic Hepatitis Delta Infection - International
This is a multicenter, randomized, controlled, open-label, Phase IIb study of HH-003 injection. HH-003 injection is a monoclonal antibody targeting hepatitis B virus. This study aims to assess efficacy and safety in participants with chronic hepatitis delta virus infection. Contact Jiaying Wen at +86-13552466248 or wenjiaying@hhhbio.com OR Mengwei Li at +86-18810689680 or limengwei@hhhbio.com and refer to identifier NCT05861674.
Currently recruiting participants in:
- China (Beijing)
Recruiting: Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD) - International
The primary objective of this study is to describe the virological response to BLV in all patients starting BLV therapy for CHD, defined as a >2 Log decline in HDV-RNA or undetectable HDV-RNA at month 12 of therapy. HDV patients who will start therapy with BLV 2 mg/day from May 2023, according to AIFA guidelines, will be consecutively enrolled. Contact Pietro Lampertico at 0255035432 or pietro.lampertico@unimi.it and refer to identifier NCT06122285.
Currently recruiting participants in:
- Italy (Milan)
This observational study will be conducted in patients with chronic co-infection with hepatitis B and D viruses, with negative PCR for HDV RNA in peripheral blood and no signs of active liver inflammation, receiving background therapy with bulevirtide for more than 48 weeks and liver biopsy performed or prescribed to be performed as part of routine practice. After the participant has signed the Informed Consent, a portion of the liver biopsy collected as part of routine practice will be sent to the laboratory for PCR testing for HDV RNA, background therapy with bulevirtide will be interrupted, and the patient will be observed in the clinic in accordance with routine medical practice, but at least one time every four weeks, for timely detection of relapse of the hepatitis D and initiation of antiviral therapy. Once a relapse of viral hepatitis D is determined via the PCR HDV RNA, the individual's participation in the study will be terminated. The collected data will be analyzed to assess the probability of relapse over time. This is an observational study and does not offer any treatment. Contact Pavel Bogomolov at +7 495 320 06 66 or bogomolov.po@ums-03.ru and refer to identifier NCT06121427.
Currently recruiting participants in:
- Russian Federation (Moscow)
Recruiting: Find HDV and Determine Its Status in Turkey - International
The aim of this study is to determine the prevalence of hepatitis delta virus (HDV) infections and the prognosis of HDV patients in Turkey's southeast. The investigators intend to arrange training sessions for 250 family physicians in Diyarbakir, Batman, Mardin, and Sanliurfa, in order to achieve this goal and to ensure that participants with simultaneous HDV infection are evaluated for HIV/HCV and have liver fibrosis detected with a non-invasive method. This is an observational study and does not offer any treatment. Contact Yaşar Bayındır at 00905323659909 or yasar.bayindir@guven.com.tr OR Mustafa Kemal Çelen at 00905336207022 and refer to identifier NCT06248580.
Currently recruiting participants in:
- Turkey
Recruiting: D-SOLVE Cohorts (Cohort A and B) (HDV750) - International
This multicenter cohort should enable a comprehensive and unbiased biomarker screening of well-defined individuals living with hepatitis delta, followed by mechanistic studies to determine the functional role of distinct molecules. Patient surveillance strategies and antiviral treatment approaches could be personalized which should reduce clinical and social disease burden, improve quality of life, and save direct and indirect costs caused by HDV infection. This is an observational study and does not offer any treatment. Contact Petra Doerge at +495115326057 or doerge.petra@mh-hannover.de OR Julia Kahlhöfer at kahlhoefer.julia@mh-hannover.de and refer to identifier NCT06160635.
Currently recruiting participants in:
- Germany
- Italy
- Romania
- Sweden
Recruiting: Standardizing Care for Hepatitis Delta in the Netherlands (DREAM-2) - International
The objective of this study is to generate prospective follow-up data to increase understanding of hepatitis delta. The study will span five years, during which researchers will collect standard clinical data as well as blood samples and quality of life questionnaires from participants living with hepatitis delta. Researchers will be looking for incidence of liver-related events (liver cancer, (decompensation of) cirrhosis, liver transplantation) during follow-up and changes in markers of viral replication, inflammatory activity, and liver stiffness over time. This is an observational study and no treatment will be offered to participants. Contact Lesley Patmore at +31629677982 or l.patmore@erasmusmc.nl and refer to identifier NCT05903742.
Currently recruiting participants in:
- Netherlands (Rotterdam)
This is a retrospective and prospective, multicenter study. Consecutive patients with HDV-related compensated cirrhosis starting Bulevirtide 2 mg/day from September 2019 to December 2025 will be enrolled in the study. The aim of this study is to investigate virological and clinical effectiveness of Bulevirtide 2 mg/day in patients with HDV-related compensated cirrhosis in the real-life setting. The primary endpoint of the study is the rate of virological response, defined as at least 2 Log decline or undetectable HDV RNA compared to baseline, at week 96 of treatment. This is an observational study and no treatment will be offered to participants. Contact Pietro Lampertico at 0255035432 or pietro.lampertico@unimi.it and refer to identifier NCT06397859.
Currently recruting participants in:
- Italy (Milan)
Recruiting: HDV-Europe: Prevalence and Outcomes of HDV in HIV/HBV Co-Infection - International
The aim of this project is to set up a cross-sectional cohort study to assess the implementation of EACS guidelines for HDV-testing among people living with HIV (PLWH) with positive HbsAg, and thereby evaluate the prevalence of HDV infection among HIV/HBV-coinfected populations in 2023, as well as corresponding risk factors. In addition to the testing itself, this study will also set up a cohort and database for future HDV studies among PLWH, including clinical, virological, and laboratory parameters. This is an observational study and no treatment will be offered to participants. Contact Jürgen Rockstroh at +491716575969 or juergen.rockstroh@ukbonn.de and refer to identifier NCT06264583.
Currently recruiting participants in:
- Germany (Bonn)
The COVID-19 global pandemic killed more than six million people worldwide. Several vaccines have been developed against the virus that causes this disease. These vaccines are effective at preventing severe symptoms and death from COVID-19. Some people with chronic liver disease, especially those with an advanced condition called cirrhosis, do not respond to many vaccines as well as healthy people do. The goal of this natural history study is to find out how well people with chronic liver disease respond to the COVID-19 vaccines and how chronic liver disease affects the body's immune response to vaccination against COVID-19.
The purpose of this Phase 3 study is to evaluate the effect of once daily dosing of lonafarnib 50 mg with ritonavir 200 mg over a 48-week treatment period with a 24-week post-treatment follow-up on HDV viral levels.
JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection via a ribonucleic acid interference mechanism. This Phase 2 study is designed to evaluate safety and efficacy of JNJ-73763989 in HBV-infected participants who are co-infected with HDV.
Not Yet Recruiting: Prevalence and Burden of Hepatitis D Virus Infection in China Through Preoperative Examination Test (Predict Study) - International
The purpose of this study is to test HDV-Ab/RNA for 5000 HBsAg reactive samples from 10 major tertiary hospitals and to understand the prevalence and disease burden of HDV in China at a national level. This is an observational study and no treatment will be offered to participants. No contacts or locations are listed for this study at this time.
Not Yet Recruiting: Registry-Based Study in Patients with Hepatitis D Virus (HDV) Infection in China - International
This is an observational, noninterventive, registry study, meaning that no treatment will be offered to participants. Patients diagnosed with HDV infection (based on positive HDV RNA) are included in this study and followed for at least 5 years to evaluate their disease progression and clinical outcomes (including liver transplantation, hepatocellular carcinoma [HCC], liver decompensation, and cirrhosis). Contact Dr. Lai Wei at +86-10 5611 8881 or weilai@mail.tsinghua.edu.cn or Feng Xue at +86-18810799293 or xuef21@mail.tsinghua.edu.cn and refer to identifier NCT05451082.
Will recruit participants in:
- China (Beijing)
This is an open-label, randomized, multi-center Phase 2 study in patients with chronic HBV and HDV co-infection. There will be two treatment groups in this study, with 15 participants per group as follows: Group 1: TAF (Tenofovir) 25 mg orally (PO) QD for 60 weeks with P1101 450 µg subcutaneously (SC) Q2W add-on at treatment week 12 for 48 weeks; Group 2: Ursodeoxycholic Acid (UDCA)* 15 mg/kg orally (PO) QD plus TAF 25 mg orally (PO) QD for 60 weeks, with P1101 450 µg subcutaneously (SC) Q2W add-on at treatment week 12 for 48 weeks. Both groups will have a post-treatment follow-up of 24 weeks. Contact Pei-Jer Chen at 886-2-23123456 ext 67072 or peijerchen@ntu.edu.tw and refer to identifier NCT05467553.
Will recruit participants in:
- Taiwan (Taipei)
Not Yet Recruiting: Patient Knowledge, Beliefs & Barriers to Hepatitis D Care - International
This is a project to understand the determinants of health behavior among those with chronic hepatitis D virus (HDV) infection, under the care of the viral hepatitis service at Kings College Hospital (KCH). This is to improve and implement pathways and patient information distribution to improve access to care in an ethnically diverse population living with HDV in the UK. This is an observational study and no treatment will be offered to participants. Contact Sital Shah at 02032999000, x35714 or sitalshah@nhs.net and refer to identifier NCT06017375.
Will recruit participants in:
- UK (London)
This is a multicenter, prospective, single-arm, discontinuation study in which patients who have been treated with bulevirtide (BLV) for at least 48 weeks, are intentionally discontinued from the treatment. Currently, the treatment duration has not yet been defined and BLV can be given as long as a clinical benefit is evident. In patients with advanced liver disease, maintenance treatment is recommended by most experts.
In pivotal phase II studies in which patients were treated with BLV for 24-48 weeks, some patients (10-20%) maintained a reduced HDV viral load with normal liver enzymes after the end of treatment. However, it is completely unclear which patients are able to control HDV infection without antiviral therapies. Biomarkers (physical signs in the body) would be needed to identify patients in whom treatment can stopped safely. Thus, the main aim of this study is to explore biomarkers in blood and liver associated with maintained virological control of HDV after at least 24 weeks of HDV-RNA levels below 100 IU/ml, with at least two tests plus one test at screening, on BLV treatment. Treatment will be stopped with the beginning of the study and patients will be followed for 48 weeks. The investigators hypothesize that biomarker-based criteria should be able to identify patients with a sustained immune control. This information would be highly relevant to personalize treatment duration (or stopping) of BLV treatment, could reduce long-term disease burden, would enable safer treatments and also reduce treatment costs. This is an observational study of participants already taking BLV - no new treatment will be offered. Contact Heiner Wedemeyer at +49 511 532 ext 3005 or Wedemeyer.heiner@mh-hannover.de OR Esther Grahl at +4917615327247 or bul-stop.zks@mh-hannover.de and refer to identifier NCT06603311.
Will recruit participants in:
- Germany (Hannover)
Not Yet Recruiting: MIGrant Reflex Test HDV (MIGRED) Project - International
The research team for this project has executed a robust strategy to improve viral hepatitis detection and linkage to care in migrants. The hypothesis for this study is that the extension of the model to three other large university clinical centers operating in southern Italy and the use of HDV reflex testing for participants living with hepatitis B will improve knowledge about the prevalence of HDV in migrants living in southern Italy and coming from areas where HDV is common. It is expected to enroll at least 7500 participants. The project will last 18 months. This is an observational study and no treatment will be offered to participants. It is meant only to diagnose individuals living with hepatitis delta and connect them to appropriate care. Contact Nicola Coppola at +390815666223 or nicola.coppola@unicampania.it OR Laura Occhiello at +393282715100 or laura.occhiello@unicampania.it and refer to identifier NCT06539052. No location information is yet listed for this study.
The goal of this phase two clinical trial is to evaluate the efficacy and safety of the drug L47 in the treatment of chronic hepatitis D (CHD). Participants with compensated CHD who satisfy the eligibility criteria are sorted by the presence or absence of liver cirrhosis and randomized into three groups at a 1:1:1 ratio. The participants will receive continuous L47 (2.1 mg/d and 4.2 mg/d, subcutaneously (under the skin)) treatment for 48 weeks (groups A and B), or delayed treatment for 48 weeks (group C). Primary endpoint evaluation will be performed after the participants complete the 48-week treatment. Contact Xiaolu Tang at 86-21-68412368 ext 609 or tangxiaolu@heppharma.com OR Xian Gao at 86-21-68412368 ext 605 or gaoxian@heppharma.com and refer to identifier NCT06505928.
Will recruit participants in:
- Mongolia (Ulaanbaatar)
This study is divided into two substudies (cross-sectional and longitudinal). The primary objective of the cross-sectional study is to calculate the prevalence of HDV-specific T-cell responses in patients with chronic HBV-HDV infection who have not been treated with bulevirtide before. The primary objective of the longitudinal study is to understand the change in the prevalence of HDV-specific T-cell responses in patients with chronic HBV-HDV infection during treatment with bulevirtide compared to baseline (pre-treatment). This is an observational study and no treatment will be offered to participants. Contact Pietro Lampertico at 0255035432 or pietro.lampertico@unimi.it and refer to identifier NCT06504485.
Will recruit participants in:
- Italy (Milan)
Clinical Trial Process
Learn more about all current hepatitis delta clinical trials.
Additional Resources
www.clinicaltrials.gov is a service of the National Institutes of Health that provides a list of all the clinical trials that are being carried out in the United States and abroad. You can search for a clinical trial by disease, drug therapy, or trial location.
https://www.ciscrp.org/services/search-clinical-trials/ offers a free search service by the Center for Information and Study on Clinical Research Participation (CISCRP) to help you find a clinical trial that may be right for you.
Hepatitis B Clinical Trials Page is a list of clinical trials specific for hepatitis B that is updated each month by the Hepatitis B Foundation.