CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 457 enrolled
Drug / intervention
GSK3228836 +2 moredrug
Likely dose
GSK3228836 150 mgfrom 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/NCT04449029
NCT04449029Phase 2Completed
CompareCT.gov

Phase IIb Multi-Center, Randomised, Partial-Blind Parallel Cohort Study to Assess the Efficacy and Safety of Treatment With GSK3228836 in Participants With Chronic Hepatitis B Virus (B-Clear)

GlaxoSmithKline·interventional·Posted Jun 26, 2020·Updated May 16, 2023

In Brief

A Phase 2 clinical trial evaluating GSK3228836, Placebo, and 1 other intervention for Hepatitis B. Completed, enrolled 457 participants across 121 sites in 22 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesArgentina, Bulgaria, Canada, China, France, Germany, Hong Kong, Italy, Japan, Malaysia, Philippines, Poland, Romania, Russia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJun 26, 2020
Enrollment StartJul 27, 2020
Primary CompletionMar 18, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.0 years ago

Interventions

GSK3228836drug

GSK3228836 will be available as a clear colorless to slightly yellow solution for injection at a unit dose strength of 150 mg/mL to be administered subcutaneously once weekly.

Placebodrug

Placebo will be available as a clear colorless solution for injection to be administered subcutaneously once weekly.

Nucleos(t)ide therapydrug

Participants receiving nucleos(t)ide therapy upon entry in the study will continue to receive nucleotide therapy for the duration of the study.