Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C
- Conditions
- Chronic HCV Infection
- Interventions
- Drug: HEC74647PA+HEC110114Drug: Placebo
- Registration Number
- NCT05395416
- Lead Sponsor
- Sunshine Lake Pharma Co., Ltd.
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 514
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HEC74647PA+HEC110114 100 mg/200 mg HEC74647PA+HEC110114 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 HEC74647PA+HEC110114 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 Placebo Placebo Phase III: HCV GT 1-6 participants were medicated with HEC74647PA Placebo Capsules once daily and HEC110114 Placebo tablets once daily
- Primary Outcome Measures
Name Time Method Sustained virologic response at 12 weeks after end of treatment (SVR12) 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 Up to posttreatment week 24 Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
- Secondary Outcome Measures
Name Time Method Percentage of subjects with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) Posttreatment Weeks 4 and 24 SVR4 and SVR24 were defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 4 and 24 weeks after stopping study treatment, respectively
Percentage of subjects with virologic failure Up to posttreatment week 24 1. On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥the lower limit of quantitation (LLOQ) after having previously had HCV RNA \<the lower limit of quantitation (LLOQ) while on treatment), or Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment);
2. Virologic relapse: Confirmed HCV RNA ≥the lower limit of quantitation (LLOQ) during the posttreatment period having achieved HCV RNA \<the lower limit of quantitation (LLOQ) at last on-treatment visit.
Related Research Topics
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Trial Locations
- Locations (36)
Hainan Provincial People's Hospital
🇨🇳Haikou, Hainan, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Anhui Provincial Hospital
🇨🇳Hefei, Anwei, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, Beijing, China
The 900th Hospital of the Joint Logistics Support Force Hospital
🇨🇳Fuzhou, Fujian, China
Foshan First People's Hospital
🇨🇳Foshan, Guangdong, China
Guangzhou Eighth People's Hospital
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The Third Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Wuhan University People's Hospital
🇨🇳Wuhan, Hebei, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Haerbin, Heilongjiang, China
Luoyang Central Hospital
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical College
🇨🇳Xinxiang, Henan, China
Henan Infectious Diseases Hospital
🇨🇳Zhengzhou, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Zhengzhou People's Hospital
🇨🇳Zhengzhou, Henan, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of South China
🇨🇳Hengyang, Hunan, China
The First People's Hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
Jiangsu Provincial Hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing Second Hospital
🇨🇳Nanjing, Jiangsu, China
Wuxi No.5 People's Hospital
🇨🇳Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Zhenjiang Third People's Hospital
🇨🇳Zhenjiang, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanyang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Tonghua Central Hospital
🇨🇳Tonghua, Jilin, China
Yanbian University Hospital
🇨🇳Yanbian, Jilin, China
The Sixth People's Hospital Of Shenyang
🇨🇳Shenyang, Liaoning, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
Huashan Hospital of the Fudan University
🇨🇳Shanghai, Shanghai, China
Tianjin Third Central Hospital
🇨🇳Tianjin, Tianjin, China
Beijing You'an Hospital,Capital Medical University
🇨🇳Beijing, China