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.
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 cotransporting 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 response 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 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, Israel, Italy, 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 to describe the long-term effects of bulevirtide treatment and evaluate the safety of participants treated with bulevirtide. 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
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
The Phase 3 LIMT-2 study will evaluate the safety and efficacy of Peginterferon Lambda treatment for 48 weeks with 24 weeks follow-up compared to no treatment for 12 weeks in participants chronically infected with HDV. The primary analysis will compare the proportion of participants with HDV RNA < LLOQ (lower limit of quantitation or the lowest amount of a substance that can be detected in a sample) at the 24-week post-treatment visit in the Peginterferon Lambda treatment group vs the proportion of participants with HDV RNA < LLOQ at the Week 12 visit in the no-treatment comparator group. Contact Nicole Ramza or Monica Gangal at 650-272-6138 or LIMT-2@eigerbio.com for more information and refer to identifier NCT05070364.
Currently recruiting participants in:
United States
- California, Illinois, New York
International
- Belgium, Bulgaria, France, Georgia, Germany, Israel, Italy, Republic of Moldova, Romania, Spain, Turkey
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, Minnesota
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 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 bulevirtide 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)
The objective of this study is to learn how chronic liver disease affects the body s immune response to vaccination against COVID-19. This is an observational study and no treatment will be offered to participants. Contact Anna L. Rivero at 301.451.7007 or anna.rivero@nih.gov OR Marc G. Ghany at 301.402.5115 or mg228m@nih.gov and reference identifier NCT05669677.
Currently recruiting participants in:
United States
- Bethesda, Maryland (National Institutes of Health)
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 Lucie Marchand at +331 53 94 80 92 or lucie.marchand@anrs.fr and refer to identifier NCT04166266.
Currently recruiting participants in:
- Lyon, 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
The primary objective of this Phase 1 study is to evaluate the safety and tolerability of sequential administration of P1101 and anti-PD1 (a group of drugs that assist the immune system in fighting off cancers) in participants with chronic hepatitis B or D infection. The secondary objectives are: 1. To explore HBsAg loss and kinetics during the study period, 2. To assess the anti-viral effect during the study period, and 3. To evaluate the rate of ALT normalization. Contact Wendy Hung at +886-2-2655-7688 ext 1397 or Wanchu_Hung@pharmaessentia.com, or Erwin Teng at +886-2-2655-7688 ext 1374 or erwin_teng@pharmaessentia.com and refer to identifier NCT04638439.
Currently recruiting participants in:
- 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 (Auckland)
- United Kingdom (London, Birmingham)
- Romania
- Moldova
Will recruit participants in:
- United Kingdom (Manchester)
- Netherlands
- Italy
- Germany
- France
- Bulgaria
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 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.
Will recruit participants in:
- Thailand
This study is designed to assess the long-term efficacy and safety of bulevirtide for treatment of CHD in comparison with delayed treatment.
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.
This is an open-label phase IIa study of HH-003 to evaluate its antiviral activity and safety in participants with chronic hepatitis B and hepatitis D co-infection. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV/HDV.
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. The study consists of 2 parts: Part 1 will evaluate safety, tolerability and antiviral activity of JNJ-73763989 + NA while Part 2 will evaluate the safety and efficacy of the JNJ-73763989 + NA regimen in the treatment of HBV/HDV co-infection. Each part includes 3 phases: Screening phase (from 4 weeks up to maximum of 8 weeks), Intervention phase (up to Week 144 for Arm A and up to Week 148 for Arm B), and Follow-Up phase (48 Weeks). The duration of individual study participation will be between 196 and 204 weeks.
Not Yet Recruiting: Testing and Epidemiology of Delta Hepatitis - US
The purpose of this study is to understand the pattern of hepatitis delta screening among medical providers for Asian patients with chronic hepatitis B, determine the proportion of Asian hepatitis B patients who have been screened and who have chronic hepatitis delta, and determine the pattern of hepatitis delta screening after education of medical providers on hepatitis delta. This is an observational study and does not offer any treatment. Contact Mimi Chang or Tse-Ling Fong at 2133871009 or mimi.chang@cimtoday.org or tselingf@usc.edu and refer to identifier NCT05181956.
Will recruit participants in:
- United States - Los Angeles, California
Not Yet Recruiting: Study of Hepalatide in Chronic Hepatitis D (CHD) Patients - International
This is a phase 2a clinical study of Hepalatide for injection in individuals living with chronic hepatitis D. This is a four-arm parallel-group, randomized, placebo-controlled, double-blind, multicenter study. The CHD participants who meet the eligibility criteria will be randomly assigned 1:1:1:1 to receive either the placebo or investigational drug (2.1 mg, 4.2 mg, or 6.3 mg), with 6 participants per group. The placebo or the corresponding dose of the investigational drug will be given for 4 consecutive weeks, followed by a 4-week follow-up period. Participants will be given entecavir for the treatment of hepatitis B infection during and after the end of the trial. 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 NCT05827146.
Will recruit participants in:
- Changchun, China
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 Lai Wei at +86-10 5611 8881 or weilai@mail.tsinghua.edu.cn of Feng Xue at (+86)18810799293 or xuef21@mail.tsinghua.edu.cn and refer to identifier NCT05451082.
Will recruit participants in:
- China (Beijing)
Not Yet Recruiting: A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects with Chronic Hepatitis Delta Infection
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. No contacts or locations have yet been provided for this study.
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)
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.
Updated May 2023