A Clinical Study to Evaluate the Efficacy and Safety of HT-101 Injection Combined With HT-102 Injection in Patients With Chronic Hepatitis B
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Proportion of participants achieving HBsAg < lower limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at W60
研究概览
简要总结
This study is A multicenter, randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the efficacy and safety of HT-101 injection combined with HT-102 injection in patients with chronic hepatitis B. It consists of two phases: the main trial and the extension period. The main trial phase aims to explore the efficacy of different courses of HT-101 injection combined with HT-102 injection in treating patients with chronic hepatitis B and evaluate the optimal treatment strategy. The extension period phase, based on the main trial, assesses the long-term safety and efficacy of HT-101 injection combined with HT-102 injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects were eligible for inclusion into the study if they met each of the following criteria:
- •Patient with CHB Male subjects weighed ≥ 45.0 kg, female subjects weighed ≥ 40.0 kg, with a body mass index (BMI) between 19.0 and 30.0 kg/m^2 (inclusive); Chronic HBV infection for >/= 6 months; The quantitation level of HBsAg was > 100 IU/mL and <3000 IU/mL; The quantitation level of HBV DNA <LLOQ;
- •· On Nas therapy for >/= 6 months at the time of screening Subjects promised to use effective contraception for at least 1 month before screening, and have no fertility, donate sperm or eggs and voluntarily take highly effective physical contraception (including partners) during the trial and within 3 months after the end of the trial;
排除标准
- •Subjects were excluded from the study if one or more of the following criteria were applicable Participants with history of drug allergy or specific allergy; Participants who had psychiatric conditions or diseases in cardiovascular, respiratory, endocrine, kidney, liver, digestive tract, skin, immune, blood, nerve and other systems; Participants with history of active pathological bleeding, or bleeding tendency; Participants with abnormal results of physical examination, vital sign examination, ECG examination, laboratory test in the screening period which were judged as clinically significant by clinicians; Participants with significant liver fibrosis or cirrhosis; Participants with symptoms or a history of hepatic decompensation; Participants with a history or suspected risk of liver cancer;
研究组 & 干预措施
Cohort B （placebo；HT-101+HT-102）
Participants will receive Placebo injection, administered Q4W for 8 weeks and sequential dosed with HT-101 injection combined with HT-102 injection, administered once every 4 weeks for another 16 weeks
干预措施: HT-101 (Drug)
Cohort A (HT-101 + HT-102)
Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks
干预措施: HT-101 (Drug)
Cohort A (HT-101 + HT-102)
Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks
干预措施: HT-102 (Drug)
Cohort B （placebo；HT-101+HT-102）
Participants will receive Placebo injection, administered Q4W for 8 weeks and sequential dosed with HT-101 injection combined with HT-102 injection, administered once every 4 weeks for another 16 weeks
干预措施: HT-102 (Drug)
Cohort B （placebo；HT-101+HT-102）
Participants will receive Placebo injection, administered Q4W for 8 weeks and sequential dosed with HT-101 injection combined with HT-102 injection, administered once every 4 weeks for another 16 weeks
干预措施: HT-101 placebo (Drug)
Cohort B （placebo；HT-101+HT-102）
Participants will receive Placebo injection, administered Q4W for 8 weeks and sequential dosed with HT-101 injection combined with HT-102 injection, administered once every 4 weeks for another 16 weeks
干预措施: HT-102 placebo (Drug)
结局指标
主要结局
Proportion of participants achieving HBsAg < lower limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at W60
时间窗: From enrollment to the end of treatment at up to 60 weeks
次要结局
- Proportion of participants achieving HBV DNA lower than LLOQ after stopping all anti-HBV treatment(From enrollment to the end of treatment at up to 60 weeks)
- HBsAg loss rate at W24, W36, W60(From enrollment to the end of treatment at up to 60 weeks)
- Maximum Change of Serum HBsAg From Baseline Description(Up to 36 weeks)
- Maximum Change of Serum HBV DNA From Baseline Description(Up to 36 weeks.)
- Incidence of adverse events (AEs) and serious adverse events (SAEs)(From enrollment to the end of treatment at up to 60 weeks)
- Clinically significant abnormalities(From enrollment to the end of treatment at up to 60 weeks)
- Maximum Plasma Concentration (Cmax)(HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.)
- Time to Reach Maximum Plasma Concentration (Tmax)(HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.)
- Area Under the Plasma Concentration Versus Time Curve (AUC)(HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.)
- Titers of Anti-drug Antibody (ADA) to HT-102 or HT-101(UP to 36 weeks)