A Phase 3 interventional study of GST-HG141 in Chronic Hepatitis b, sponsored by Fujian Akeylink Biotechnology Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 71 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Fujian Akeylink Biotechnology Co., Ltd. · Phase 3, Interventional, and Treatment
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)
942 studies on the registry are indexed under Hepatitis B, Chronic; 145 are open to participants now.
This study's planned enrollment of 576 is above the median of 100 across 683 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Fujian Akeylink Biotechnology Co., Ltd. is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laboratory test abnormalities:
GST-HG141+NAs
Drug: GST-HG141
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fujian Akeylink Biotechnology Co., Ltd.