A Phase Ⅱ/Ⅲ Study to Evaluate Efficacy and Safety of Antaitavir Hasophate Capsules in Combination With Yiqibuvir Tablets in Adult Subject With Chronic HCV Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 514
- 试验地点
- 36
- 主要终点
- Sustained virologic response at 12 weeks after end of treatment (SVR12)
研究概览
简要总结
The safety, tolerability and antiviral activity of Antaitavir Hasophate in Combination With Yiqibuvir in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) infection
详细描述
Phase II: Exploring the efficacy and safety of different doses of Antaitavir Hasophate combined with fixed-dose Yiqibuvir in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of phase III clinical trials.
Phase III: Confirmation of the efficacy and safety of Antaitavir Hasophate combined with Yiqibuvir in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a sufficient basis for drug registration and clinical use.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent;
- •Male or female, age≥18 years;
- •Body mass index (BMI)≥18.0 and≤32.0 kg/m2, and Weight≥40 kg;
- •Serological detection of anti-HCV antibodies was positive at screening;
- •HCV RNA≥1×104 IU/mL at Screening;
- •HCV genotype 1~6, mixed genotype or indeterminate assessed at Screening by the Central Laboratory.
排除标准
- •Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage);
- •Chronic liver disease of a non-HCV etiology (Including but not limited to hemochromatosis, Wilson's disease,alfa-1 antitrypsin deficiency);
- •Significant cardiac disease(Including but not limited to myocardial infarction, bradycardia) ;
- •Psychiatric illness or psychological disease or relevant medical history;
- •Solid organ transplantation;
- •Subjects have any other medical disorder that may interfere with subjects treatment, assessment or compliance with the protocol.
研究组 & 干预措施
HEC74647PA+HEC110114 100 mg/200 mg
Phase II: HCV GT 1-6 participants were medicated with HEC74647PA Capsules 100 mg or200 mg once daily and HEC110114 tablets 600 mg once daily
干预措施: HEC74647PA+HEC110114 (Drug)
HEC74647PA+HEC110114
Phase III: HCV GT 1-6 participants were medicated with HEC74647PA Capsules 100 mg /200 mg once daily and HEC110114 tablets 600 mg once daily
干预措施: HEC74647PA+HEC110114 (Drug)
Placebo
Phase III: HCV GT 1-6 participants were medicated with HEC74647PA Placebo Capsules once daily and HEC110114 Placebo tablets once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Sustained virologic response at 12 weeks after end of treatment (SVR12)
时间窗: Posttreatment Week 12
Percentage of subjects with plasma HCV RNA not detected or below the lower limit of quantitation (15 IU/mL)
Type and frequencies of Adverse events
时间窗: Up to posttreatment week 24
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
次要结局
- Percentage of subjects with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of subjects with virologic failure(Up to posttreatment week 24)