NCT05839639已完成2 期
A Multicenter, Randomized, Controlled Phase IIa Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors
Huahui Health1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2021年10月9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
- 73
- 试验地点
- 1
- 主要终点
- Changes from baseline in serum HBsAg levels
研究概览
简要总结
This is a multicenter, randomized, controlled Phase IIa study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the antiviral activity and safety in subjects with with HBeAg-negative Chronic Hepatitis B treated with nucleos(t)ide reverse transcriptase inhibitors.
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 65 Years（Adult, Older 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 65years (inclusively);
- •18 kg/m^2≤BMI≤32 kg/m^2, body weight≥45 kg for men and ≥40 kg for women;
- •At screening, etiological, clinical, or pathological evidence indicates chronic hepatitis B virus infection for at least 6 months; and negative HBeAg for more than 6 months; 10 IU/mL≤HBsAg≤3000 IU/mL; HBV DNA≤20 IU/mL; ALT≤1×ULN;
- •Participants who have been on the treatment of nucleos(t)ide reverse transcriptase inhibitors (limited to entecavir [ETV], tenofovir disoproxil fumarate [TDF], or tenofovir alafenamide fumarate [TAF]) for at least 3 years (as judged by the investigator) at screening.
排除标准
- •Females who are pregnant or lactating at screening;
- •History of alcoholic liver disease, non-alcoholic steatohepatitis, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-HBV infection;
- •History or presence of progressive liver fibrosis or cirrhosis, including but not limited to liver stiffness measurement [LSM] ≥ 9 kPa at screening, progressive liver fibrosis or cirrhosis (e.g., S ≥ 3 in GS score or METAVIR ≥ F3) by liver histopathology examination, according to the Consensus on the diagnosis and therapy of hepatic fibrosis [2019]; or the presence of ascites, hepatic encephalopathy, upper gastrointestinal bleeding, or esophageal and gastric varices.
- •History or presence of hepatocellular carcinoma, or alpha-fetoprotein (AFP) ≥ 50 ng/mL at screening; or suspicion of hepatocellular carcinoma indicated by liver ultrasound, CT, or MRI.
- •Use of antiviral therapy with interferon within 1 year prior to screening
- •Any of the following lab test 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), Serum albumin < 35 g/L; international normalized ratio (INR) of prothrombin time > 1.3; or estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2.
研究组 & 干预措施
HH-003+NrtIs
Experimental
干预措施: HH-003+NrtIs (Drug)
NrtIs
Active Comparator
干预措施: NrtIs (Drug)
HH-003
Experimental
干预措施: HH-003 (Drug)
结局指标
主要结局
Changes from baseline in serum HBsAg levels
时间窗: From treatment start to Week 24
Proportion of participants achieving sustained viral response
时间窗: From baseline to Week 24
次要结局
- Proportion of participants with undetectable HBV DNA in those with positive HBV DNA at baseline(From treatment start to Week 24)
- Proportion of participants achieving sustained viral response(From baseline to Week 48)
- Changes from baseline in serum HBsAg levels(From treatment start up to Week 48)
- Proportion of participants with HBV pgRNA negativation in those with positive HBV pgRNA at baseline(From baseline to Week 24)
- Duration of sustained viral response(From treatment start to Week 48)
- Proportion of participants with normal ALT levels(From treatment start to Week 48)
研究者
研究点 (1)
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