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NCT04449029 · ClinicalTrials.gov registry record · Phase 2
A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 457
- Enrollment target
NCT04449029: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT04449029 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 457 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (244% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04449029, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 457 participants
- Enrollment target
Study Summary
Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem. GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and in CHB participants on stable nucleos(t)ide therapy. This study is intended to evaluate if treatment with GSK3228836 can achieve sustained virologic response (SVR), that is hepatitis B virus surface antigen (HBsAg) less than (\<) lower limit of quantitation (LLOQ) and HBV deoxyribonucleic acid (DNA) \<LLOQ sustained for 24 weeks post-GSK3228836 treatment end. In addition, the study will also evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of GSK3228836 in the 4 dosing regimens. This study will assess the efficacy and safety of treatment with GSK3228836 in two populations of participants with CHB; participants on stable nucleos(t)ide treatment (Cohort 1) and participants who are not currently on nucleos(t)ide therapy (Cohort 2). For each population, participants will be randomized into one of the 4 different parallel arms to receive treatment. The study will consist of a screening, treatment, and post-treatment follow-up phase. Approximately, 440 participants will be enrolled in the study.
Primary Outcome
The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication.
Interventions
- DRUG Placebo
- DRUG GSK3228836
- DRUG Nucleos(t)ide therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 457 participants |
| Start Date | 2020-07-27 |
| Est. Completion | 2022-03-18 |
| Phase | Phase 2 |
What the finished NCT04449029 record still lists
NCT04449029 is an interventional study that assigns participants to a tested intervention. The registered 457 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (244% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04449029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04449029 about?
NCT04449029 is a clinical study titled "A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)". Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem. GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and in CHB participants on stable nucleos(t)ide therapy. This study is intended to evaluate if treatment with GSK3228836 can a...
What is the current status of trial NCT04449029?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 457 participants. The study started on 2020-07-27. Estimated completion is 2022-03-18.
What interventions are being tested in trial NCT04449029?
The interventions under investigation include: Placebo (DRUG), GSK3228836 (DRUG), Nucleos(t)ide therapy (DRUG).
Who is sponsoring clinical trial NCT04449029?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04449029's enrollment target sits among peer trials
457 84th of 2000 higher than 1,917 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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