Clinical Trials

Clinical trials are research studies that test new potential treatments for a disease. Talk to your doctor about possible clinical trials that could be helpful to you.

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

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: John Ferraro 650-272-6138 or DLIVR@eigerbio.com and refer to identifier NCT03719313.

Currently recruiting patients in:

United States

  • Miami, FL - University of Miami Schiff Center for Liver Disease. Contact: Katheryn Dae at 305-243-1104
  • Norman, OK - Central Sooner Research. Contact: Kurt Smith at 405-329-0474 or email ksmith@centralsooner.com

International   

Phase 3 Clinical Study to Assess Efficacy and Safety of Bulevirtide (Myrcludex B) in Patients With Chronic Hepatitis Delta - Sites To Be Announced

This study is designed to assess the long-term efficacy and safety of Bulevirtide in patients with HDV. Contact Dr. Yana Deloveri at +74957265253 or email deloveri@myr-pharma.com and refer to identifier NCT03852719.

Clinical trial sites to be announced

Phase 2b Study of Bulevirtide (With Peginterferon Alfa-2a) in Patients With CHD

A Multicenter, Open-label, Randomized Phase 2b Clinical Study. Contact: Yana Deloveri at +491777168259 or email deloveri@myr-pharma.com and refer to identifier NCT03852433.

Projected clinical trial locations:

  • Russia
  • France
  • Moldova
  • Romania

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 Wedemeyer.Heiner@mh-hannover.de or Dr. Svenja Hardtke at Hardtke.Svenja@mh-hannover.de and refer to identifier NCT02375906.

Currently recruiting patients in: 

  • Manaus, Brazil 
  • Rondonia, Brazil
  • Berlin, Germany
  • Hannover, Germany
  • Larissa, Greece
  • Karachi, Pakistan
  • Ankara, Turkey

Phase 2 Study of Ezetimibe for Patients With Chronic Hepatitis D – Pakistan

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.

Evaluation of Patients with Liver Disease, Including Hepatitis D – U.S.

Evaluate, investigate and follow-up patients suffering from acute and chronic liver disease. Qualified patients may be able to participate in other offered studies. Contact Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. T. Jake Liang at 301-496-1721 jakel@mail.nih.gov and refer to identifier NCT00001971.

Clinical Trial Process

Clinical Trial Process FlowChart

Learn more about all current HDV 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. 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 that is updated each month by the Hepatitis B Foundation of clinical trials specific for hepatitis B.

Updated April 2019.