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
Available: Expanded Access for Bulevirtide
The goal of this study is to provide access to bulevirtide (BLV (GS-4438), Hepcludex®) to eligible participants with chronic hepatitis delta virus infection (CHD). Contact Gilead Clinical Study Information Center at 1-833-445-3230 (GILEAD-0) or GileadClinicalTrials@gilead.com and refer to identifier NCT06780579. No location information is currently available for this program.
Recruiting: "Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases". (LivMOD) - International
Development of preclinical translational models for chronic liver tumors and diseases study, such as spheroids cultured in autologous medium and murine xenograft models to test the efficacy of new therapeutic strategies. This is an observational study and no treatment will be offered to participants. Contact Dr. Thomas Baumert at 03 68 85 37 03 or thomas.baumert@unistra.fr and refer to identifier NCT04690972.
Currently recruiting participants in:
- France (Strasbourg)
This study is designed to assess safety, tolerability, and pharmacokinetics of single ascending doses (SAD) and multiple-ascending doses (MAD) of ABI-6250 in healthy participants. Effect of food will also be evaluated in Part A. Contact Assembly Biosciences at 833-509-4583 or clinicaltrials@assemblybio.com and refer to identifier NCT06740474.
Currently recruiting participants in:
- New Zealand (Auckland)
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
- United Kingdom
Recruiting: National Cohort of Patients Co-infected with Hepatitis B and Delta Viruses (HEPDELTA) - International
This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from participants with HBV/HDV co-infection. Participants will be monitored according to the usual recommendations, depending on their status:
- Participants who have never received specific treatment for hepatitis Delta (untreated or receiving treatment with peginterferon alpha 2a alone) will be monitored according to current recommendations, once every 6 months;
- Participants treated or having been treated with a specific hepatitis Delta treatment will be monitored according to the compassionate access protocol or according to the recommendations of the AMM during treatment and according to routine follow-up after the end of treatment.
Participation in research entails the following additional procedures for patients, for each line of treatment, where applicable:
- Samples for the biobank,
- Self-administered questionnaires.
This is an observational study and no treatment will be offered to participants. Contact Fatoumata Coulibaly at +331 44 23 61 10. x33/fatoumata.coulibaly@anrs.fr or Claire Fougerou-Leurent at claire.fougerou@chu-rennes.fr and refer to identifier NCT04166266.
Currently recruiting participants in:
- France
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment. Contact 415-654-5281 or clinicaltrials@vir.bio and refer to identifer NCT06903338.
Currently recruiting participants in:
- United States
- Canada
- Georgia
- Republic of Moldova
- Romania
- Ukraine
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: 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. 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 is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug. Contact Bluejay Clinical Trials Information at +1 650 912-5231 or ClinicalTrials@bluejaytx.com and refer to identifier NCT06907290.
Currently recruiting participants in:
- United States (California, Florida, Texas)
- Republic of Moldova
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)
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
The D-SOLVE consortium ("Understanding the individual host response against Hepatitis D Virus to develop a personalized approach for the management of hepatitis D"), aims for an unbiased screening of a large multicenter cohort of well-defined individuals living with hepatitis D to better understand individual factors determining the outcome of infection and to identify participants benefitting from currently available treatments.
The D-SOLVE cohorts will be collected retrospectively as well as prospectively with clinical and virological data and biomaterial for the biomarker analysis. The aim of the cohorts is as following:
Cohort A: To define the demographic, clinical, virological, and immunological features of a large cross-sectional cohort of 750 untreated and treated HDV patients at 4 EU centers. To compare these features among patients with different origin, gender, disease severity and treatment. To collect biological material to generate translational studies, aimed to better understand pathogenesis, natural history and treatment response.
Cohort B: To identify histological and immunological features that are associated with fibrosis progression and clinical complications in people living with chronic 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, decompensated 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. 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)
Recruiting: HDV Screening Study - International
This is a territory-wide (Hong Kong) cross-sectional study of all individuals living with HIV/HBV coinfection and HBV-related HCC, testing for hepatitis delta virus. This is an observational study and no treatment will be offered to participants. Contact Angel Chim at +85235054205 or angelchim@cuhk.edu.hk and refer to identifier NCT06889805.
Currently recruiting participants in:
- Hong Kong
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.
Currenlty recruiting 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.
Currently recruiting participants in:
- Italy (Milan)
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.
Currently recruiting participants in:
- Germany (Hannover, Berlin, Frankfurt, Heidelberg)
- Italy (Milan)
Active, Not Currently Recruiting: Hepatitis Delta Virus Infection: Cross-sectional Study in Patients With Chronic Hepatitis B Virus Infection
The goal of this observational study is to determine the prevalence of hepatitis D virus (HDV) and the distribution of the HDV genotype in patients with chronic hepatitis B infection. It will also identify factors related to hepatitis D virus infection, such as characteristics of the study sample, vaccination history, drug use affecting hepatitis, family factors, environment, and lifestyle. Refer to identifier NCT06638320.
Active, Not Currently Recruiting: Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of RBD1016 in Participants With Chronic Hepatitis D - International
The goal of this clinical trial is to learn if drug RBD1016 works to treat chronic hepatitis D virus infection in adults. It will also learn about the safety of drug RBD1016. The main questions it aims to answer are: Does drug RBD106 reduce the HDV RNA levels? What medical problems may participants experience when taking drug RBD1016? Researchers will compare drug RBD1016 to a placebo to see if drug RBD1016 works to treat chronic hepatitis D. Refer to identifier NCT06649266.
The current study aims to validate the DBS tool for HDV serological and molecular testing using capillary blood. The hypothesis posits that geographical barriers to accessing hospitals and laboratories for HDV patients complicate the shipping of frozen plasma samples, increasing costs. Developing a serological screening and viral load testing technique from a drop of capillary blood on DBS paper could effectively link patients to specialized centers. Since DBS is considered non-infectious, it also mitigates administrative complications. Contact Dr. Frederic Le Gal at 01 48 95 74 03 ext +33 or frederic.legal@aphp.fr OR Valérian Delagarde at 01 48 95 55 55 Poste 52747 ext +33 or valerian.delagarde@aphp.fr and refer to identifier NCT06649396.
Will recruit participants in:
- France (Bobigny)
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)
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 laura.occhiello@unicampania.it and refer to identifier NCT06539052. No location information is yet listed for this study.
The aim of this study is to screen the Mongolian community in France for viral hepatitis, and then initiate a program of care and treatment. Contact Francois Bailly at +33 4 26 73 27 33 or francois.bailly@chu-lyon.fr and refer to identifier NCT07038863.
Will recruit participants in:
- France
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.