NCT07090759

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

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Trial of GST-HG141（Neracorvir）for Combination Therapy (add-on) in Patients With Inadequate Response to Antiviral Drugs in Chronic Hepatitis B (CHB)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 526 (estimated)
• Sponsor: Fujian Akeylink Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. This research project enrolled a total of 526 CHB patients who have an inadequate response to hepatitis B antiviral treatment. They were divided into two groups, with 263 patients in each group. The qualified participants were randomly assigned to the GST-HG141 group and the placebo group at a ratio of 1:1.

Conditions

• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	GST-HG141	GST-HG141 50 mg BID
DRUG	GST-HG141 Placebo	GST-HG141 Placebo BID

Timeline

• Start date: 2025-07-24
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2025-07-29
• Last updated: 2026-01-23

Locations

1 site across 1 country: China