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Virus Therapy

Participants receiving Bepirovirsen for Hepatitis B (B-Focus Trial)

Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Documented chronic HBV infection and documented HIV-1 infection greater than equal to (\>=)12 months prior to screening.
* Must be on uninterrupted ART containing at least Tenofovir disoproxil (TDF) or Tenofovir alafenamide (TAF) plus Lamivudine (3TC) or Emtricitabine (FTC) for greater than (\>)12 months, with no planned changes to the stable regimen over the duration of the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study week 60
Awards & highlights

Summary

This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with Human Immunodeficiency Virus (HIV)/Hepatitis B Virus (HBV) co-infection.

Who is the study for?
This trial is for people who have both HIV and chronic Hepatitis B. Specific details about eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to follow specific protocols related to their conditions.
What is being tested?
The study is testing the effectiveness and safety of a medication called bepirovirsen compared to a placebo in individuals with both HIV and chronic Hepatitis B virus infection.
What are the potential side effects?
While the side effects of bepirovirsen are not detailed here, common side effects for antiviral drugs can include headaches, nausea, fatigue, and sometimes more serious reactions depending on individual health factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study week 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and at study week 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of participants achieving HBV virologic response at 36 weeks after scheduled end of study treatment in absence of rescue medication
Secondary study objectives
Percentage of participants achieving HBV virologic response at the scheduled end of study treatment in absence of rescue medication

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants receiving BepirovirsenExperimental Treatment1 Intervention
Participants will receive bepirovirsen
Group II: Participants receiving PlaceboPlacebo Group1 Intervention
Participants will receive placebo

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Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,788 Previous Clinical Trials
8,176,686 Total Patients Enrolled
168 Trials studying Hepatitis B
340,645 Patients Enrolled for Hepatitis B
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,601 Previous Clinical Trials
6,144,876 Total Patients Enrolled
130 Trials studying Hepatitis B
333,172 Patients Enrolled for Hepatitis B
~100 spots leftby Jan 2027
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