Clinical Research Directory
Browse clinical research sites, groups, and studies.
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.
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
Conditions
Interventions
GST-HG141
GST-HG141 50 mg BID + NAs