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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


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 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 a maximum of 8 Weeks), Intervention phase (144 Weeks for Arm A and 148 Weeks 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 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 - 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 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 Patients In: 

United States

  • California, Illinois, New York

Internationally

  • 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 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 - International

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 affects 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

Currently recruiting patients in:

United States

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

Internationally

  • Belgium, Bulgaria, Canada, 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 patients in: 

  • Lyon, France

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 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 patients in: 

  • Taiwan

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, collect clinical information, and keep those living with hepatitis delta informed about their infection. 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

Unclear If Still 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 declines 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. 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 patients in:

  • United States - Bethesda, Maryland (National Institute of Health)

 Active, Not Currently 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.


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.

Currently recruiting patients 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.

Currently recruiting patients in: 

  • Reunion Island

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 February 2022