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

NCT04449029 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 457

Last updated 2023-05-16

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2022-03-18
Completion
2022-03-18
FDA Drug
Yes

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

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04449029 on ClinicalTrials.gov