Clinical trials: Chronic Hepatitis Delta Virus Infection
Viral Hepatitis
A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide
- Trial name
- NCT07128550
- Testing
- Tobevibart, Elebsiran, Bulevirtide
- Where
- 38 sites in Austria, France and 5 more
- Volunteers
- 150 people
- Sponsor
- Vir Biotechnology, Inc.
Hepatitis D, Chronic, Hepatitis B, Chronic
Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)
The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected with hepatitis virus B and D.
- Trial name
- NCT00686790
- Testing
- Peginterferon alfa-2b (PegIntron, SCH 54031)
- Volunteers
- 68 people
- Sponsor
- Merck Sharp & Dohme LLC
Glucose Metabolism Disorders, Liver Fibrosis
Change of Glucose Metabolism and Fibrosis Markers in Patients With Hepatitis C Under Treatment With Antiviral Agents
Chronic hepatitis C infection is associated with changes of glucose metabolism end increased frequency of impaired glucose tolerance. This might be a additional risk factor for disease and fibrosis progression.
- Conditions
- Glucose Metabolism Disorders, Liver Fibrosis, Hepatitis C
- Trial name
- NCT03908294
- Testing
- Lab tests, non-invasive fibrosis (Fibroscan/ARFI)
- Where
- Germany
- Volunteers
- 46 people
- Sponsor
- Johann Wolfgang Goethe University Hospital
Chronic Hepatitis D Infection
Lonafarnib With and Without Ritonavir in HDV (LOWR-1)
To Evaluate the Safety and Efficacy of Lonafarnib with and without Ritonavir Boosting in Adults With Genotype 1 Chronic Hepatitis D Virus (HDV) Infection (LOWR-1).
- Trial name
- LOWR-1 (NCT02430181)
- Testing
- lonafarnib, peginterferon alfa-2a, ritonavir
- Where
- Turkey (Türkiye)
- Volunteers
- 21 people
- Sponsor
- EIT Pharma, Inc.
Chronic Hepatitis D Infection
Lonafarnib Boosted With Ritonavir With and Without Peginterferon Alfa-2a (PEG IFN-a) in HDV (LOWR-2)
An Open-label, Dose-ranging Study to Evaluate the Safety and Efficacy of Lonafarnib with Ritonavir Boosting +/- Peginterferon alfa-2a in Patients Chronically Infected with Delta Hepatitis (HDV) (LOWR-2).
- Trial name
- LOWR-2 (NCT02430194)
- Testing
- lonafarnib, ritonavir, Pegylated interferon-alfa-2a
- Where
- Turkey (Türkiye)
- Volunteers
- 55 people
- Sponsor
- EIT Pharma, Inc.
Hepatitis D, Chronic
An Observational Study on the Prevalence of Chronic Hepatitis D in Romania and the Efficacy of Treatment With Pegasys (Peginterferon Alfa-2a)
This prospective, multicenter, observational study will assess the prevalence of chronic hepatitis D in patients with chronic hepatitis B in Romania and evaluate the efficacy of Pegasys (peginterferon alfa-2a) in patients with…
- Trial name
- NCT01861444
- Where
- Romania
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis D Infection
A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection
This study is designed to assess safety, pharmacokinetics, and efficacy ABI-6250 in participants with Chronic Hepatitis D Virus Infection.
- Trial name
- NCT07762027
- Testing
- ABI-6250
- Where
- 22 sites in France, Georgia and 9 more
- Volunteers
- 80 people
- Sponsor
- Assembly Biosciences
Hepatitis B, Hepatitis D
Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)
Patients with chronic HBV infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF) and/or pegylated interferon (PEG IFN) alpha 2a therapy, and be…
- Trial name
- MONARCH (NCT02577029)
- Testing
- ARC-520, entecavir, pegylated interferon alpha 2a
- Where
- 33 sites in Australia, Bulgaria and 6 more
- Volunteers
- 79 people
- Sponsor
- Arrowhead Pharmaceuticals
Hepatitis Delta With Hepatitis B Carrier State, Chronic Hepatitis b
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.
- Trial name
- NCT06638320
- Where
- 3 sites in Vietnam
- Volunteers
- 2,452 people
- Sponsor
- Tam Anh Research Institute
Viral Hepatitis
A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
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.
- Trial name
- NCT06903338
- Testing
- Tobevibart, Elebsiran
- Where
- 39 sites in United States, Canada and 8 more
- Volunteers
- 124 people
- Sponsor
- Vir Biotechnology, Inc.
Evaluate Response to Treatment Both Biochemically and Virologically to Determine the Safety and Effectiveness of Bulevirtide Therapy in HDV Patients
Assessment of Response and Safety of Bulevirtide Treatment in Patients With Chronic Delta Virus Infection
1. The study is non-interventional, multicenter, non-profit 2. The primary objective of the study is to evaluate the safety and efficacy in clinical practice of the drug Bulevirtide in the treatment of patients with chronic HDV…
- Trial name
- ARISTOTLE (NCT07116044)
- Testing
- virological tests diagnostic tests
- Where
- Italy
- Volunteers
- 160 people
- Sponsor
- University of Molise
Chronic Hepatitis D Infection
A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)
This is an international, multicenter, randomized, controlled, open-label Phase III trial. It will evaluate the efficacy and safety of libevitug in participants with chronic HDV infection.
- Trial name
- NCT07499544
- Testing
- Libevitug 20 mg/kg, Libevitug 10 mg/kg, Delayed treatment with libevitug
- Where
- 7 sites in United States, China and 1 more
- Volunteers
- 160 people
- Sponsor
- Huahui Health
Chronic Hepatitis D
Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide
This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).
- Trial name
- NCT07454837
- Testing
- Brelovitug (BJT-778), Bulevirtide
- Where
- 46 sites in Austria, Czechia and 6 more
- Volunteers
- 120 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Chronic Hepatitis Delta
Peginterferon Lambda and Lonafarnib Boosted With Ritonavir 48-Week Combination Therapy for Delta Hepatitis
Background: Chronic hepatitis D is a serious liver disease caused by a virus. Currently, no medications are approved to treat chronic hepatitis D. Objective: To test a combination of 3 drugs in people with chronic hepatitis D.
- Trial name
- NCT05953545
- Testing
- Peginterferon Lambda
- Where
- United States
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Chronic Hepatitis Delta Virus Infection
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).
- Trial name
- NCT06780579
- Testing
- Bulevirtide
- Sponsor
- Gilead Sciences
Chronic Hepatitis Delta
Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
The goals of this clinical study are to first learn more about safety and dosing of the study drug GS-4321 in healthy participants.
- Trial name
- NCT07096193
- Testing
- GS-4321
- Where
- 28 sites in United States, Bulgaria and 7 more
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Viral Hepatitis B, Viral Hepatitis D
Replicor Compassionate Access Program
The goal of this compassionate access program is to provide early access to REP 2139-Mg for patients with HBV mono-infection or HBV / HDV co-infection who either have advanced (decompensated) cirrhosis or who have failed to…
- Conditions
- Viral Hepatitis B, Viral Hepatitis D, Cirrhosis, Liver, Decompensated Cirrhosis
- Trial name
- RCAP (NCT05683548)
- Testing
- REP 2139-Mg, Tenofovir Disoproxil Fumarate, Pegylated interferon alpha2a
- Where
- 13 sites in Austria, France and 3 more
- Sponsor
- Replicor Inc.
Chronic Hepatitis B
Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF
In Chronic hepatitis B (CHB) patients receiving long-term sequential Neucleos(t)ides(NAs), majority of these CHB patients experienced drug resistance and switched to Tenofovir disoproxil fumaratate(TDF).
- Trial name
- SWITAF (NCT03356834)
- Testing
- Tenofovir alafenamide(TAF), Tenofovir disoproxil fumarate(TDF)
- Where
- Hong Kong
- Volunteers
- 575 people
- Sponsor
- Humanity and Health Research Centre
Chronic Hepatitis B, Chronic Hepatitis D
Pegylated Interferon Alfa-2b Plus Ribavirin in Chronic Hepatitis B and Delta
The treatment of choice for chronic hepatitis D is uncertain. The investigators hypothesize that pegylated interferon (IFN) alfa-2b in combination with ribavirin (RBV) may be effective in the treatment of chronic hepatitis D…
- Trial name
- NCT00117533
- Testing
- pegylated IFN alfa-2b plus ribavirin
- Where
- 2 sites in Taiwan
- Volunteers
- 20 people
- Sponsor
- National Taiwan University Hospital
Hepatitis D
Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir
Background: Chronic hepatitis D is a liver disease caused by the hepatitis D virus (HDV). It can be severe and progressive. Most people with hepatitis D will develop scarring and damage to the liver.
- Trial name
- NCT02511431
- Testing
- Lonafarnib, Ritonavir
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)