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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, CHB = Chronic hepatitis B, HDV = Hepatitis D, 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


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

JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection via 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 Week up to a maximum of 8 Week), Intervention phase (144 Week for Arm A and 148 Week for Arm B) and Follow-up phase (48 Week). The duration of individual study participation will be between 196 and 204 weeks. Contact 844.434.4210 or JNJ.CT@sylogent.com for more information and refer to identifier NCT04535544.

Currently recruiting patients in:

United States

  • California, Maryland, Massachusetts, New Jersey

Internationally

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

 Recruiting - Improvement of Portal Hypertension During Viral Suppression in Patients with Hepatitis Delta (IMPHROVE-D) 

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 supression in these patients. This study investigates the potential effects of viral supression on PH 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-hanover.de for more information and refer to identifier NCT04863703

Currently Recruiting Patients In:

  • Germany

 Recruiting - A Study of Safety and Efficacy of ATI-2173 in Combination with Tenofovir Disoproxil Fumarate in Subjects with Chronic Hepatitis B Virus Infection and in Subjects with Hepatitis D Virus Coinfection

This is a randomized, double-blinded, placebo-controlled, multi center, dose ranging study of safety and efficacy in both volunteers with chronic hepatitis B virus infection and in volunteers with hepatitis D virus coinfection. Volunteers will be administered multiple oral doses of ATI-2173 and assessed for safety and efficacy including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the drug effects the virus infection. The contact for this study in MOLDOVA is Andrei Colesnic, who can be reached at +37379689636 or andrei.colesnic@arensia-em.com. The contact for this study in UKRAINE is Valeriia Shtepa, who can be reached at 380669411231 or valeriia.shtepa@arensia-em.com. Please refer to identifier NCT04847440.

Currently Recruiting Patients In:

  • Republic of Moldova
  • Ukraine

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 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. Also visit www.d-livrstudy.com for more information. 

Currently recruiting patients in:

United States

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

Internationally

  • Belguim, Bulgaria, Canada, France, Germany, Greece, Israel, Italy, Republic of Moldova, Mongolia, New Zealand, Pakistan, Romania, Russia, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom

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

This study is designed to assess the long-term efficacy and safety of Bulevirtide in patients with HDV. 


Active, Not Currently Recruiting - Phase 2b Study of Bulevirtide (With Peginterferon Alfa-2a) in Patients With Chronic Hepatitis Delta - International

This is a Phase 2b clinical study to assess efficacy and safety of bulevirtide in combination with pegylated interferon alfa-2a in patients with chronic hepatitis delta.


Recruiting - The Hepatitis Delta International Network - International

Multicenter, observational study (patients will not receive any treatment) that will build a registry of HDV patients around the world and collect clinical information. Contact: Dr. Heiner Wedemeyer at Heiner.Wedemeyer@uk-essen.de or Dr. Petra Doerge at Doerge.Petra@mh-hannover.de and refer to identifier NCT02375906.

Currently recruiting patients in: 

  • Austria
  • Belgium
  • Brazil
  • Georgia
  • Germany
  • Greece
  • Italy
  • Republic of Moldova
  • Pakistan
  • Romania
  • Spain
  • Vietnam

May Still Be Recruiting - Phase 2 Study of Ezetimibe for Patients With Chronic Hepatitis Delta – International

Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and HDV hepatocyte entry, that include two hydrophobes and one hydrogen bond acceptor. Therapy with ezetimibe may lead to decline in HDV levels. The aim of the study is to evaluate the utility of ezetimibe in patients with CHD. Contact: Zaigham Abbas at 922135862937 or email drzabbas@gmail.com and refer to identifier NCT03099278.

Currently recruiting patients in:

  • Sindh, Pakistan

Recruiting - Evaluation of Patients with Liver Disease, Including Hepatitis Delta – U.S.

Evaluate, investigate and follow-up with patients suffering from acute and chronic liver disease. Qualified patients may be able to participate in other offered studies. 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 patients in:

  • Bethesda, Maryland (National Institute of Health)

 Active, Not Recruiting - Hepatitis B Research Network Adult Cohort Study (HBRN) - U.S. and Canada

The primary purpose of this study is to describe participants with hepatitis B virus (HBV) infection and identify factors that may cause the disease to activate or worsen. This study includes people who also have hepatitis delta or have tested positive for the hepatitis delta antibody. This is an observational study where no treatment will be administered.


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.

www.searchclinicaltrials.org 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 June 2021