- ongoing, recruitingTherapeutic confirmatory (Phase III)
Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in Nucleos(t)ide Analogue-treated Participants with Chronic Hepatitis B Virus (B-Well 1)
This study is testing a new medicine, bepirovirsen, for adults with long-term hepatitis B. We want to see if it can help people stop all their hepatitis B treatment and stay well, hoping for a 'functional cure' where the virus is controlled.
Spain · Romania · France - ongoing, recruitingTherapeutic confirmatory (Phase III)
Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in Nucleos(t)ide Analogue-treated Participants with Chronic Hepatitis B Virus (B-Well 2)
This study is looking into a new treatment called Bepirovirsen for people with long-term Hepatitis B. It's hoped this treatment could help some people stop all their Hepatitis B medicines. Researchers want to see if it works well and is safe.
Romania · Germany · Poland - ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humans
A first-time-in human (FTIH), Phase I/II, randomized, multi-centric, single-blind, controlled dose-escalation study to evaluate the reactogenicity, safety, immunogenicity and efficacy of GSK Biologicals’ HBV viral vector vaccines given in a prime-boost schedule with sequential or co-administration of adjuvanted proteins therapeutic vaccine (GSK3528869A) in chronic Hepatitis B patients (18-65 years old) well controlled under nucleo(s)tide analogue (NA) therapy.
This study is testing a new vaccine for chronic Hepatitis B in adults aged 18 to 65. We want to see how safe it is, if it causes side effects, and if it helps the body fight the virus. Participants are already managing their condition with medication.
Belgium · Germany · Spain - ongoing, recruitingTherapeutic exploratory (Phase II)
A phase 2, single-blinded, randomised, controlled multi-country study to evaluate the safety, reactogenicity, efficacy and immune response following sequential treatment with an anti-sense oligonucleotide (ASO) against chronic Hepatitis B (CHB) followed by chronic Hepatitis B targeted immunotherapy (CHB-TI) in CHB patients receiving nucleos(t)ide analogue (NA) therapy.
Researchers are testing a new treatment for long-term hepatitis B in people already on medication. The study will look at how safe the new treatment is and if it helps reduce the virus in the body.
Belgium · Italy · Germany - ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humans
Four-part, Randomized, Double-blind (Parts 1, 2A, 3 and 4), Multi-center, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK3965193 Monotherapy in Healthy Participants and in Participants Living with Chronic Hepatitis B Infection; and GSK3965193 in Combination with Bepirovirsen in Participants Living with Chronic Hepatitis B Infection
This study is testing a new medicine, GSK3965193, for people with chronic hepatitis B. We want to see if it's safe, how it works, and if it can help reduce the virus, especially when combined with another treatment called bepirovirsen.
France · Italy - ongoing, recruitingHuman Pharmacology (Phase I)- Other
A study to investigate the safety and tolerability of dostarlimab in adult participants with chronic HBV infection on nucleos(t)ide analogue (NA) treatment
This study is looking at a new medicine called dostarlimab for adults with long-term hepatitis B. Participants are already taking other hepatitis B medicines. The main aim is to see if dostarlimab is safe and whether people can comfortably take it alongside their current treatment.
Bulgaria · France · Italy - active not recruitingPHASE2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
This study is testing new medicines, daplusiran/tomligisiran (DAP/TOM) and bepirovirsen, for people with long-term Hepatitis B. It aims to find the best dose of DAP/TOM to use with bepirovirsen to improve treatment.
United States · Australia · Belgium - enrolling by invitation
EuroSIDA - Clinical and Virological Outcome of European Patients Infected With HIV
The EuroSIDA study looks at how HIV affects people in Europe and how treatments work over time. It helps us understand health changes and the impact of new medicines for HIV and related conditions like hepatitis.
Argentina · Austria · Belarus - recruitingPHASE2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
This study is checking if the benefits of bepirovirsen for Hepatitis B last over time. It's for people who previously took part in a bepirovirsen trial and showed good results. No new treatment is given in this follow-up study, just monitoring.
United States · Argentina · Bulgaria - active not recruitingPHASE2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
This study is looking into a new medication called Bepirovirsen for people who have both HIV and long-term Hepatitis B. It will compare Bepirovirsen to a dummy treatment (placebo) to see if it's safe and effective in improving their health.
United States · Argentina · Brazil