NCT03801798Unknown2 期
A Double-blind, Randomized, Placebo Controlled, Parallel-group, Phase 2a Study to Evaluate the Efficacy and Safety of GC1102 in Combination With Nucleos(t)Ide Analogues (NAs) in Patients With Chronic Hepatitis B
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of GC1102 in combination of Nucleo(t)ide analogues (NAs) in patients with chronic hepatitis B
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had this study information explained to them and understood it, voluntarily decided participation, and provided written consent
- •Patients who Aged ≥19 and ≤ 65 years at the time of signing the consent form
- •Patients with chronic hepatitis B who have been taking Nucleos(t)ide analogue antivirals 24 weeks before screening
- •Patients whose HBsAg and HBV DNA in blood; 10 IU/mL ≤ HBsAg titer ≤ 1,000 IU/mL and negative(-; below the limit of detection of 10 IU/mL) HBV DNA in the screening test
排除标准
- •Patients who have Hepatic diseases (e.g., autoimmune hepatitis) from causes other than hepatitis B
- •Patients who have history of liver transplantation, or liver transplantation schedule during the study
- •Patients who co-infected with HAV, HCV, HDV and HIV
- •Patient with Vasculitis
- •Patients who had a loss of blood or donated blood of ≥ 400mL within 8 weeks before the screening
- •patient who have active infection(other than chronic hepatitis B infection) requiring continual treatment with antibiotics or antivirals (except for clinically insignificant temporary infection such as cold)
研究组 & 干预措施
NAs antivirals + GC1102 180,000 IU
Experimental
All patients are currently being treated with long-term NA treatment(more than 24 weeks) and will continue using these during the study.
Each vial contains 1mL of study drug or placebo; Single IV bolus injection of 18mL
- V2 to V17 : IV bolus injection twice a week
- V18 to V33 : IV bolus injection once a week
干预措施: GC1102 (Drug)
NAs antivirals + GC1102 Placebo
Placebo Comparator
All patients are currently being treated with long-term NA treatment(more than 24 weeks) and will continue using these during the study.
Each vial contains 1mL of study drug or placebo; Single IV bolus injection of 18mL
- V2 to V17: IV bolus injection twice a week
- V18 to V33: IV bolus injection once a week
干预措施: GC1102 Placebo (Other)
结局指标
主要结局
Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
时间窗: from baseline at Week 48 after the first dose of investigational product
HBsAg titer
次要结局
- Proportion of subjects with ≥ 1log10 reduction in HBsAg titer(from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product)
- Change in HBsAg titer(from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product)
- Proportions of subjects with ≥ 0.5log10 reduction in HBsAg titer(from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product)
- ALT response rates(from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product)
- HBeAg seroconversion rates(from baseline at Weeks 12, 24, 36 an 48 after the first dose of investigational product)
- Rate of HBsAg loss(from baseline at Weeks 12, 24, 28, 36 and 48 after the first dose of investigational product)
- Proportion of negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point(from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product)
研究者
研究点 (1)
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