Authors
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Nanfang Hospital, Southern Medical University -More
Category
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Primary study
Registry of Trials»Chinese Clinical Trial Register
Year
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2026
INTERVENTION: Trial group A:HT‐101 injection + HT‐102 injection for 24 weeks;Trial group B:Placebo for 8 weeks + HT‐101 injection + HT‐102 injection for 16 weeks; CONDITION: Chronic hepatitis B who have received NAs treatment PRIMARY OUTCOME: Proportion of participants achieving functional cure at week 60 [defined as HBsAg clearance (<0.05 IU/mL) and undetectable serum HBV DNA]; SECONDARY OUTCOME: HBsAg clearance rate at week 8;Proportion of participants achieving functional cure at weeks 24 and 36;HBsAg clearance rate at weeks 24, 36, and 60;Quantitative HBsAg levels and relative change from baseline at weeks 24, 36, 48, and 60;HBsAg seroconversion rate at weeks 24, 36, and 60;HBsAb seroconversion rate at weeks 24, 36, and 60;Quantitative HBsAb levels and relative change from baseline at weeks 24, 36, and 60;Quantitative HBV DNA levels and relative change from baseline in participants with detectable HBV DNA at weeks 24, 36, and 60;Quantitative HBV RNA, HBcrAg, and HBcAb levels and relative change from baseline in participants with detectable levels at weeks 24, 36, and 60;Positive rate of HBeAb in HBeAb‐negative patients at weeks 24, 36, and 60;Proportion of participants meeting stopping criteria for nucleos(t)ide analogues (NAs) at week 36; INCLUSION CRITERIA: 1. Age: 18 ‐ 70 years old (inclusive of 18 and 70); 2. Gender: Male or female; 3. Male subjects: Body weight >= 45.0 kg; 4. Female subjects: Body weight >= 40.0 kg; 5. Body Mass Inde X(BMI) should be within 19.0 ‐ 30.0 kg/m^2 (including boundary values), [BMI = weight (kg) / height^2 (m^2)]; 6. Patients who have been treated with NAs and are clinically diagnosed with chronic hepatitis B (serum HBsAg positive for >= 6 months) are defined as follows: NAs‐treated patients: Have a continuous >= 6‐month history of nucleoside (acid) analogues anti‐hepatitis B treatment, and at the screening stage, are receiving stable antiviral treatment with a single nucleoside (acid) analog [such as emtricitabine‐foxpine (TAF), aemifovipirine (TMF), emtricitabine‐ethyl (TDF), or entecavir (ETV), etc.] for at least 3 months, with HBeAg negative, and the HBV DNA test result before the first use of the investigational drug was lower than the quantitative limit (research cent
Epistemonikos ID: 265a3414ca9ed3af800432380bee1738e482f56f
First added on: Oct 08, 2026