NCT05674448终止2 期
An Open-label Phase IIa Study to Evaluate the Antiviral Effect and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and D Co-infection
Huahui Health1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2021年8月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Percentage of Participants with HDV RNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24
研究概览
简要总结
This is an open-label phase IIa study of HH-003 to evaluate its antiviral activity and safety in subjects with chronic hepatitis B and hepatitis D co-infection. 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/HDV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 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 subjects aged from 18 to 70 years inclusively;
- •18 kg/m2≤BMI≤32 kg/m2, body weight ≥45 kg for men and ≥40 kg for women;
- •Positive HBsAg, anti-HDV IgG antibody and HDV RNA at screening;
- •Women of childbearing potential or male subjects with female partners of childbearing potential should agree to use an adequate and highly effective contraceptions from screening to the end of study or until 12 weeks after last dose of the study drug (whichever is longer).
排除标准
- •Be pregnant or lactating at screening;
- •Subjects with decompensated liver cirrhosis;
- •Subjects with liver dysfunction (including but not limited to ascites, hepatic encephalopathy and upper gastrointestinal bleeding) within 3 months prior to screening;
- •Average daily alcohol consumption >40g for men and >20g for women or drug abuse within 6 months prior to screening;
- •Subjects with other serious diseases that is inappropriate for study participation per the Investigator's or the Sponsor's discretion (including but not limited to serious cardiac or pulmonary disease, chronic or recurrent urinary disorders, uncontrolled diabetes and autoimmune diseases, epilepsy requiring treatment);
- •History of hepatocellular carcinoma (HCC) or hepatocellular carcinoma suggested by liver histopathology or liver imaging;
- •Interferon antiviral therapy within 1 year prior to screening.
研究组 & 干预措施
HH-003 20mg/kg
Experimental
HH-003 20mg/kg, intravenously, Q2W
干预措施: HH-003 20mg/kg (Biological)
HH-003 3mg/kg
Experimental
HH-003 3mg/kg, intravenously, Q2W
干预措施: HH-003 3mg/kg (Biological)
结局指标
主要结局
Percentage of Participants with HDV RNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24
时间窗: Week 24
Percentage of Participants with HBV DNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24
时间窗: Week 24
Change from Baseline in Serum HBsAg Levels at Week 24
时间窗: from baseline to Week 24
次要结局
- Percentage of participants with ALT normalization at week 24(Week 24)
- Changes from Baseline in Serum HBsAg Levels during the Study Period(from baseline to Week 48)
- Changes from Baseline in Serum HDV RNA Levels during the Study Period(from baseline to Week 48)
- Changes from Baseline in Serum HBV RNA Levels during the Study Period(from baseline to Week 48)
- Changes from Baseline in Serum HBV DNA Levels during the Study Period(from baseline to Week 48)
- Changes from Baseline in Serum HBeAg Levels in HBeAg-positive Subjects at Screening(from baseline to Week 48)
研究者
研究点 (1)
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