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RECRUITING
NCT07090759
PHASE3

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

Sponsor: Fujian Akeylink Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

526

Start Date

2025-07-24

Completion Date

2027-03-01

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

DRUG

GST-HG141

GST-HG141 50 mg BID

DRUG

GST-HG141 Placebo

GST-HG141 Placebo BID

Locations (1)

Shulan(Hangzhou) Hospital

Hangzhou, Zhejiang, China