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ACTIVE NOT RECRUITING Phase 3

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)

NCT05630807 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 981 participants
Start Date 2022-12-07
Est. Completion 2026-05-05
Phase Phase 3

Sponsor

GlaxoSmithKline

558 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 981 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05630807 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05630807?

The interventions under investigation include: Placebo (OTHER), Bepirovirsen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05630807?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial