A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Trial of GST-HG141（Neracorvir）for Combination Therapy (add-on) in Patients With Inadequate Response to Antiviral Drugs in Chronic Hepatitis B (CHB)
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.
• Male or female individuals aged 18-70 years (inclusive of the boundaries);
• Male weight ≥ 50 kg, female weight ≥ 45 kg, with a body mass index (BMI) within the range of 18-35 kg/m2 (inclusive of the boundaries);
• Have been continuously taking nucleoside analogues (entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\], emivirofavir \[TMF\], or propivirofavir \[TAF\]) as monotherapy or in combination therapy 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
• HBeAg positive, serum HBV DNA can be detected by high-sensitivity PCR, and HBV DNA \> 50 IU/mL;
• At the time of screening, ALT ≤ 5×ULN;
• Male participants with a fertile female partner or female participants of childbearing age who are willing to voluntarily take effective contraceptive measures from the time of screening until 28 days after the completion of the study ;
• Sign the informed consent form before the trial and be able to complete the study as required by the trial protocol.