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NCT05630807 · ClinicalTrials.gov registry record · Phase 3
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)
A Phase 3 study of Chronic Hepatitis B and Hepatitis B， Chronic, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 3
- Development phase
- 981
- Enrollment target
- 20
- Study locations
NCT05630807: Active Phase 3 study of Chronic Hepatitis B and Hepatitis B， Chronic, sponsored by GlaxoSmithKline.
NCT05630807 is a Phase 3 study of Chronic Hepatitis B and Hepatitis B， Chronic that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 981 participants, above the 224-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (338% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05630807, a Phase 3 study of Chronic Hepatitis B and Hepatitis B， Chronic, is active but no longer recruiting, sponsored by GlaxoSmithKline.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 981 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48. The arms will be stratified based on HBsAg level (HBsAg greater than or equal to \[≥\] 100 international unit per milliliter \[IU/mL\] to less than or equal \[≤\]1000 IU/mL or greater than \[\>\] 1000 IU/mL to ≤3000 IU/mL) at screening. The total duration of the study, including screening (up to 60 days), the double-blind treatment stage (24 weeks), the On NA only stage (24 weeks), and the NA cessation and durability stages (48 weeks) is up to approximately 104 weeks at maximum for each participant.
Primary Outcome
The number of participants who achieved FC after discontinuation of all chronic HBV treatment (bepirovirsen/placebo and NA) in the absence of rescue medication will be reported. The FC for HBV is defined as Sustained suppression (24 weeks or longer) of HBV DNA \< Lower limit of quantification (LLOQ) off all HBV treatment and HBsAg not detected with or without HBsAb after a finite duration of therapy.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Bepirovirsen
Study Locations (20)
Other
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Capital Federal
- GSK Investigational Site - Pilar
- GSK Investigational Site - Rosario
- GSK Investigational Site - Aracaju
- GSK Investigational Site - Campinas
California
- GSK Investigational Site - Davis
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Palo Alto
- GSK Investigational Site - San Jose
Virginia
- GSK Investigational Site - Richmond
- GSK Investigational Site - Richmond
Arizona
- GSK Investigational Site - Chandler
Colorado
- GSK Investigational Site - Littleton
Florida
- GSK Investigational Site - Miami
Iowa
- GSK Investigational Site - Iowa City
Maryland
- GSK Investigational Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 981 participants |
| Start Date | 2022-12-07 |
| Est. Completion | 2026-05-05 |
| Phase | Phase 3 |
What the registry record for NCT05630807 still lists
NCT05630807 is an interventional study that assigns participants to a tested intervention. The registered 981 participants enrollment target is mid-sized for trials with a published cap, above the 224-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (338% higher).
The record links to 2 conditions, with Chronic Hepatitis B appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05630807 names 20 study sites across 9 states, led by Other, California, Virginia.
Frequently Asked Questions
What is clinical trial NCT05630807 about?
NCT05630807 is a clinical study titled "Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)". This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blin...
What is the current status of trial NCT05630807?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 981 participants. The study started on 2022-12-07. Estimated completion is 2026-05-05.
What conditions does trial NCT05630807 study?
This clinical trial studies the following conditions: Chronic Hepatitis B, Hepatitis B， Chronic.
What interventions are being tested in trial NCT05630807?
The interventions under investigation include: Placebo (OTHER), Bepirovirsen (DRUG).
Who is sponsoring clinical trial NCT05630807?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05630807 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Hepatitis B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05630807's enrollment target sits among peer trials
981 1st of 14 higher than 14 of 14 other Chronic Hepatitis B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Hepatitis B trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)
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Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed
COMPLETED · Phase 3
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A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine
COMPLETED · Phase 3
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VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B
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Intrahepatic and Peripheral Responses to Imdusiran (AB-729) in Chronic Hepatitis B
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