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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
576
GST-HG141 50 mg BID + NAs
To evaluate the safety of GST-HG141 combined with NAs treatment
Treatment-emergent AE incidence rate
Time frame: up to 52 weeks
The percentage of participants in the experimental group of Study GST-HG141-III-01 with HBV DNA < 20 IU/mL after completing this study and receiving 48 weeks of GST-HG141 combined with NAs treatment.
Time frame: up to 48 weeks
Among participants of Study GST-HG141-III-01 who had HBV DNA ≥ 20 IU/mL after completing double-blind treatment, the percentage of participants with serum HBV DNA < 20 IU/mL following 48 weeks of treatment in this study.
Time frame: up to 48 weeks
The percentage of participants with serum HBV DNA < 20 IU/mL at each visit time point.
Time frame: up to 48 weeks
The percentage of participants with serum HBV DNA < 10 IU/mL at each visit time point.
Time frame: up to 48 weeks
Changes from baseline in quantitative serum HBV DNA levels at each visit time point.
Time frame: up to 48 weeks
Time to achieve serum HBV DNA < 20 IU/mL in each group.
Time frame: up to 48 weeks
The percentage of participants with serum HBsAg seroclearance at each visit time point.
Time frame: up to 48 weeks
Changes from baseline in quantitative hepatitis B surface antigen (HBsAg) levels at each visit time point.
Time frame: up to 48 weeks
Changes from baseline in quantitative serum hepatitis B virus pregenomic RNA (HBV pgRNA) levels at each visit time point.
Time frame: up to 48 weeks
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