Clinical trials: Chronic Hepatitis Delta Virus Infection, active
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.
Chronic Hepatitis D Infection
A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection
This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection.
- Trial name
- NCT06907290
- Testing
- Brelovitug 300 mg, Brelovitug 900 mg, Delayed Treatment with Brelovitug 300mg
- Where
- 30 sites in United States, Australia and 9 more
- Volunteers
- 150 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
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.
Hepatitis D, Chronic
SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.
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
- Trial name
- NCT05461170
- Testing
- VIR-2218, VIR-3434, NRTI
- Where
- 20 sites in Bulgaria, France and 7 more
- Volunteers
- 95 people
- Sponsor
- Vir Biotechnology, Inc.
Hepatitis D
Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
Multicenter pharmacological observational prospective, no-profit, study. This study was designed to get a "real-life" snapshot across several Italian Hepatology centers.
- Trial name
- D-SHIELD (NCT06122285)
- Testing
- Bulevirtide
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Hepatitis D, Chronic, Hepatitis B, Chronic
National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from patients with HBV/HDV co-infection.
- Trial name
- HEPDELTA (NCT04166266)
- Testing
- Blood draw for the laboratory assessment
- Where
- 38 sites in France
- Volunteers
- 800 people
- Sponsor
- ANRS, Emerging Infectious Diseases
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.
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
Viral Hepatitis
A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection
A Study to Evaluate Tobevibart+Elebsiran versus Bulevirtide in Chronic HDV Infection
- Trial name
- NCT07142811
- Testing
- Tobevibart, Elebsiran, Bulevirtide
- Where
- 31 sites in Belgium, Bulgaria and 9 more
- Volunteers
- 100 people
- Sponsor
- Vir Biotechnology, Inc.
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 D, Chronic, Hepatitis B Chronic Infection
Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a Phase 1b, Open-label Trial in Individuals With Chronic Hepatitis D Infection
Hepatitis D virus (HDV) is a major global health issue, with an estimated 12 million people living with the infection worldwide.
- Trial name
- NCT07610772
- Testing
- HepB mAb19
- Where
- 2 sites in Denmark, Germany
- Volunteers
- 15 people
- Sponsor
- Aarhus University Hospital
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
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
Chronic Hepatitis D Infection
A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD).
- Trial name
- NCT07200908
- Testing
- Brelovitug 300 mg, Bulevirtide 2 mg and Brelovitug - 300 mg
- Where
- 57 sites in Austria, Czechia and 10 more
- Volunteers
- 172 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Chronic Hepatitis D Infection
A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection.
- Trial name
- NCT07298330
- Testing
- Brelovitug 300 mg, Brelovitug 900 mg, Delayed Treatment with Brelovitug 300mg
- Where
- 27 sites in United States, Belgium and 8 more
- Volunteers
- 80 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Compensated Liver Disease (Disorder), Hepatitis D, Chronic
Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of HDV Infection
Finding biomarkers for stopping bulevirtide treatment of patients with hepatitis delta
- Trial name
- BUL-STOP (NCT06603311)
- Testing
- Stop Treatment with Bulevertide in patients with compensated liver disease and chronic HDV infection
- Where
- 5 sites in Germany, Italy
- Volunteers
- 20 people
- Sponsor
- Hannover Medical School
Chronic Hepatitis D
Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of RBD1016 in Participants With Chronic Hepatitis D
The goal of this clinical trial is to learn if drug RBD1016 works to treat chronic hepatitis D virus infection in adults. It will also learn about the safety of drug RBD1016.
- Trial name
- NCT06649266
- Testing
- RBD1016
- Where
- 2 sites in Sweden
- Volunteers
- 14 people
- Sponsor
- Ribocure Pharmaceuticals AB
Chronic Hepatitis B Infection
Hepatitis B Infection Surveillance
France is a low-endemicity country for hepatitis B virus (HBV) infection. In 2016, the prevalence of chronic HBV infection in the general population was estimated at 0.3%, corresponding to more than 135,000 HBsAg-positive…
- Trial name
- HEPB-SURVEY (NCT07727187)
- Where
- France
- Volunteers
- 1,360 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
HDV, HDV Infection
D-SOLVE Cohorts (Cohort A and B)
Hepatitis D is by far the most severe form of chronic viral hepatitis, frequently leading to liver failure, hepatocellular carcinoma and death.
- Conditions
- HDV, HDV Infection, Chronic Liver Disease
- Trial name
- HDV750 (NCT06160635)
- Where
- 4 sites in Germany, Italy and 2 more
- Volunteers
- 750 people
- Sponsor
- Hannover Medical School