To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment
NCT07090759 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 526
Last updated 2026-01-23
Summary
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GST-HG141 in patients with chronic hepatitis B who have an inadequate response to antiviral drug treatment.
Conditions
Interventions
- DRUG
-
GST-HG141
GST-HG141 50 mg BID
- DRUG
-
GST-HG141 Placebo
GST-HG141 Placebo BID
Sponsors & Collaborators
-
Fujian Akeylink Biotechnology Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-24
- Primary Completion
- 2026-12-01
- Completion
- 2027-03-01
Countries
- China
Study Locations
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