CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 108 enrolled
Drug / intervention
GSK3228836 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04676724
NCT04676724Phase 2Completed
CompareCT.gov

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)

GlaxoSmithKline·interventional·Posted Dec 21, 2020·Updated May 2, 2024

In Brief

A Phase 2 clinical trial evaluating GSK3228836, PegIFN, and 1 other intervention for Hepatitis B. Completed, enrolled 108 participants across 49 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesCanada, China, Italy, Japan, Poland, Russia, South Africa, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 21, 2020
Enrollment StartJan 28, 2021
Primary CompletionFeb 17, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.5 years ago

Interventions

GSK3228836drug

Participants will be administered GSK3228836.

PegIFNdrug

Participants will be administered PegIFN.

NA therapydrug

Participants will continue to receive their NA therapy for the duration of the study.