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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05630807
The ClinicalTrials.gov registry entry for NCT05630807 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 981 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 224-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (338% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.
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