Trials / Completed
CompletedNCT04676724
Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB)
A Phase IIb Multi-Center, Randomised, Open Label Study to Assess the Efficacy and Safety of Sequential Treatment With GSK3228836 Followed by Pegylated Interferon Alpha 2a in Participants With Chronic Hepatitis B Virus (B-Together)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is intended to evaluate if 12 or 24 weeks of treatment with GSK3228836 followed by up to 24 weeks of pegylated interferon (PegIFN) can increase the rate of hepatitis B virus surface antigen (HBsAg) loss in participants on stable nucleos(t)ide analogue (NA) therapy, and whether virologic response can be sustained once PegIFN treatment is discontinued. Participants will be randomized to receive GSK3228836 for 12 or 24 weeks followed by up to 24 weeks of PegIFN.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK3228836 | Participants will be administered GSK3228836. |
| DRUG | PegIFN | Participants will be administered PegIFN. |
| DRUG | NA therapy | Participants will continue to receive their NA therapy for the duration of the study. |
Timeline
- Start date
- 2021-01-28
- Primary completion
- 2023-02-17
- Completion
- 2023-02-17
- First posted
- 2020-12-21
- Last updated
- 2024-05-02
- Results posted
- 2024-05-02
Locations
49 sites across 11 countries: United States, Canada, China, Italy, Japan, Poland, Russia, South Africa, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04676724. Inclusion in this directory is not an endorsement.