A Phase 3 interventional study of GST-HG141 and GST-HG141 Placebo in Chronic Hepatitis b, sponsored by Fujian Akeylink Biotechnology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Fujian Akeylink Biotechnology Co., Ltd. · Phase 3, Interventional, and Treatment
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.
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.
This research project enrolled a total of 526 CHB patients who have an inadequate response to hepatitis B antiviral treatment. They were divided into two groups, with 263 patients in each group.
The qualified participants were randomly assigned to the GST-HG141 group and the placebo group at a ratio of 1:1.
942 studies on the registry are indexed under Hepatitis B, Chronic; 145 are open to participants now.
This study's planned enrollment of 526 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.
Have been continuously taking nucleoside analogues (entecavir [ETV], tenofovir disoproxil fumarate [TDF], emivirofavir [TMF], or propivirofavir [TAF]) for more than one year (with a break of less than one month in the past year), and are receiving treatment at the time of screening and agree to accept the treatment plan provided by this study during the study period;
* Have maintained the same NA monotherapy for more than 3 months before screening
Exclusion Criteria:
Laboratory tests:
Drug: GST-HG141
Drug: GST-HG141 Placebo
GST-HG141 50 mg BID
GST-HG141 Placebo BID
Proportion of participants with serum Hepatitis B Virus (HBV) DNA
Proportion of participants with serum Hepatitis B Virus (HBV) DNA \< lower limit of quantification (LLOQ) treatment period;
Time frame: Up to 48 weeks
Serum HBV DNA
The changes of HBV DNA level compared to baseline;
Time frame: Up to 48 weeks
Plan to share: No
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Fujian Akeylink Biotechnology Co., Ltd.