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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.

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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


Recruiting: Once Daily Dosing of Lonafarnib Co-Administered with Ritonavir for Treatment of Chronic Hepatitis D Virus Infection (LOWR6) - International

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. Contact Ohad Etzion at +972-8-6403330/ohadet@clalit.org.il or Ruthie Bekore at +972-8-6244240/ruthieb@clalit.org.il for more information and refer to identifier NCT05229991.

Currently recruiting participants in:

  • Israel, New Zealand, Turkey

Recruiting: A Study of JNJ-73763989 + Nucleos(t)ide Analog in Participants Co-Infected with Hepatitis B and Hepatitis Delta Virus (REEF-D) - US & International

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 patients 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. Contact 844.434.4210 or Participate-In-This-Study@its.jnj.com for more information and refer to identifier NCT04535544.

Currently recruiting participants in:

United States

  • California, Maryland, Massachusetts, New Jersey

International

  • Australia, Brazil, China, France, Germany, Italy, Japan, New Zealand, Russian Federation, Spain, Sweden, Taiwan, Turkey, United Kingdom

Recruiting: Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients with Chronic HDV (LIMT-2) - US & International

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 patients chronically infected with HDV. The primary analysis will compare the proportion of patients 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 patients 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, Germany, Israel, Italy, Republic of Moldova, Romania, Russian Federation, Spain, Turkey, Ukraine

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 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 patients 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)

Recruiting: Phase 3 Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon-Alfa-2a (D-LIVR) - U.S. and International

Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG IFN-alfa-2a and (2) LNF/RTV. Each of these arms will have efficacy endpoints that measure clinical benefit with regard to viral suppression and alanine aminotransferase (ALT) normalization. For each LNF-containing regimen, a composite endpoint of EOT (48 weeks) virologic response and ALT normalization will be used. Virologic response will be defined as a 2 log10 IU/mL reduction from baseline. Contact: Sue Speyer 650-272-6138 or DLIVR@eigerbio.com and refer to identifier NCT03719313

Currently recruiting participants in:

United States

  • California, Connecticut, Florida, Illinois, Iowa, Maryland, Michigan, New York, Oklahoma, Texas

International

  • Belgium, Bulgaria, Canada (Alberta, Ontario, and Quebec), France, Germany, Greece, Israel, Italy, Republic of Moldova, Mongolia, New Zealand, Pakistan, Romania, Russia, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom

Recruiting: Observatory Study of Efficacy and Safety of Bulevirtide (Hepcludex) in Patients with Chronic HBV/HDV Co-Infection (BuleDelta) - International

This is a prospective, multicentric, non-comparative study, with a retrospective data collection aiming at evaluating the efficacy and safety of bulevirtide in patients with chronic HBV/HDV co-infection with severe fibrosis injuries, or moderate fibrosis injuries associated with persistent increase of ALT. 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

Recruiting: The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults with Chronic Hepatitis B or D Infection - International

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 patients 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, subjects 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. Subjects that qualify for medications presently being studied may be offered the opportunity to benefit from experimental therapy. Contact Patricia E. Alcivar at 301-435-6121/patricia.alcivar@nih.gov or Dr. T. Jake Liang at 301-496- 1721/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)

Active, Not Currently Recruiting: Phase 3 Clinical Study to Assess Efficacy and Safety of Bulevirtide (Hepcludex) in Patients With Chronic Hepatitis Delta

This study is designed to assess the long-term efficacy and safety of Bulevirtide for treatment of CHD in comparison with delayed treatment. 


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: Epidemiology of Hepatitis B, C, and Delta in Reunion Island (HEPEPID) - International

This study aims to better understand the characteristics of patients with hepatitis B, C and Δ in Reunion Island, their follow-up, their evolution and complications. This is an observational study and does not offer any treatment. Contact Olivier Maillard at +262693025589 or olmaillard@yahoo.fr and refer to identifier NCT03362866.

Recruiting participants in: 

  • Reunion Island

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: 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.

Recruiting participants in:

  • Thailand

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 (Bejing)

Not Yet Recruiting: A Study to Compare P1101 Plus TAF With or Without UDCA in Patients with HBV and HDV Coinfection - International

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 subjects 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

Clinical Trial Process FlowChart

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 November 2022