Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07588009
PHASE3

Phase IIIB Extension Clinical Trial of Efficacy and Safety of GST-HG141 (Nairevir) Combined With NAs in Chronic Hepatitis B

Sponsor: Fujian Akeylink Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a multicenter, single-arm, open-label, phase IIIb extension clinical trial designed to evaluate the long-term safety and tolerability of GST-HG141 (nerlecovir, 50 mg BID) in combination with nucleos(t)ide analogues (NAs) in patients with chronic hepatitis B (CHB) who completed 48 weeks of treatment in the phase III study (GST-HG141-III-01), did not discontinue prematurely, had an overall medication compliance rate of ≥80%, and were willing to continue treatment. A maximum of 578 eligible participants will be enrolled at 64 centers, including those who completed the preceding study, had ALT ≤5× upper limit of normal (ULN), and had no severe comorbidities (e.g., decompensated cirrhosis, other viral infections, or malignant tumors)

Official title: A Single-Arm, Open-Label, Multicenter Phase IIIB Extension Clinical Trial to Evaluate the Efficacy and Safety of GST-HG141 (Nairecovir) in Combination With Nucleos(t)Ide Analogs (NAs) in Patients With Chronic Hepatitis B

Key Details

Gender

All

Age Range

18 Years - 71 Years

Study Type

INTERVENTIONAL

Enrollment

576

Start Date

2026-06-26

Completion Date

2028-03-01

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

DRUG

GST-HG141

GST-HG141 50 mg BID + NAs