NCT04449029

A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 457 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	GSK3228836	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.
DRUG	Placebo	Placebo will be available as a clear colorless solution for injection to be administered subcutaneously once weekly.
DRUG	Nucleos(t)ide therapy	Participants receiving nucleos(t)ide therapy upon entry in the study will continue to receive nucleotide therapy for the duration of the study.

Timeline

• Start date: 2020-07-27
• Primary completion: 2022-03-18
• Completion: 2022-03-18
• First posted: 2020-06-26
• Last updated: 2023-05-16
• Results posted: 2023-05-16

Locations

121 sites across 22 countries: United States, Argentina, Bulgaria, Canada, China, France, Germany, Hong Kong, Italy, Japan, Malaysia, Philippines, Poland, Romania, Russia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study