NCT05734807已完成2 期
A Multicenter, Randomized, Controlled Phase IIa Study to Evaluate the Antiviral Activity and Safety of HH-003 in Nucleos(t)Ide Analogues-treated Chronic Hepatitis B Subjects With Low-Level Viremia
Huahui Health8 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2022年7月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 8
- 主要终点
- Percentage of subjects with HBV DNA negativation
研究概览
简要总结
This is a multicenter, randomized, controlled Phase IIa study of HH-003 to evaluate the antiviral activity and safety in nucleos(t)ide analogues-treated chronic hepatitis B subjects with low-level viremia. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form;
- •Male or female aged from 18 to 60 years (inclusively);
- •18 kg/m^2≤BMI≤30 kg/m^2, body weight≥50 kg for men and ≥45 kg for women;
- •Subjects who have chronic HBV infection greater than or equal to 6 months at screening;
- •10 IU/mL≤HBsAg≤3000 IU/mL; HBV DNA≤2000 IU/mL; ALT≤3×ULN;
- •Subjects who have been on nucleoside reverse transcriptase inhibitors therapy for more than 1 year prior to screening.
排除标准
- •Females who are pregnant or lactating at screening;
- •History of alcoholic liver disease, moderate fatty liver, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-HBV infection;
- •History of cirrhosis at any time prior to or at time of screening, or having progressive liver fibrosis at screening ;
- •History or evidence of hepatocellular carcinoma at any time prior to or at time of screening;
- •Exclusionary laboratory results at screening: total bilirubin >2xULN or direct bilirubin >1.5xULN，hemoglobin <120 g/L for males or <110 g/L ro females，platelets count<100,000/mm^3 (100×10^9/L), and absolute neutrophils count <1,500/mm^3 (1.5×10^9/L).
研究组 & 干预措施
NrtIs
Active Comparator
干预措施: Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs) (Drug)
HH-003+NrtIs
Experimental
干预措施: HH-003 and NrtIs (Drug)
HH-003+NrtIs+PEG-IFN-α
Experimental
干预措施: HH-003, NrtIs and PEG-IFN-α (Drug)
结局指标
主要结局
Percentage of subjects with HBV DNA negativation
时间窗: Week 24
Changes from baseline in serum HBsAg
时间窗: From treatment start up to Week 48
次要结局
- Duration of MVR(From treatment start up to 48 weeks)
- Percentage of subjects achieving maintained virologic response (MVR)(From treatment start up to 48 weeks)
- Changes from baseline in serum HBeAg in subjects with positive HBeAg(From treatment start up to 48 weeks)
- Percentage of subjects with ALT normalization(From treatment start up to 48 weeks)
研究者
研究点 (8)
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