Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C
NCT ID: NCT05395416
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
514 participants
INTERVENTIONAL
2021-06-21
2023-04-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
HEC74647PA+HEC110114
administered orally once daily for 12 weeks
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
HEC74647PA+HEC110114
administered orally once daily for 12 weeks
Placebo
Phase III: HCV GT 1-6 participants were medicated with HEC74647PA Placebo Capsules once daily and HEC110114 Placebo tablets once daily
Placebo
administered orally once daily for 12 weeks
Interventions
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HEC74647PA+HEC110114
administered orally once daily for 12 weeks
Placebo
administered orally once daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female, age≥18 years;
3. Body mass index (BMI)≥18.0 and≤32.0 kg/m2, and Weight≥40 kg;
4. Serological detection of anti-HCV antibodies was positive at screening;
5. HCV RNA≥1×104 IU/mL at Screening;
6. HCV genotype 1\~6, mixed genotype or indeterminate assessed at Screening by the Central Laboratory.
Exclusion Criteria
2. Chronic liver disease of a non-HCV etiology (Including but not limited to hemochromatosis, Wilson's disease,alfa-1 antitrypsin deficiency);
3. Significant cardiac disease(Including but not limited to myocardial infarction, bradycardia) ;
4. Psychiatric illness or psychological disease or relevant medical history;
5. Solid organ transplantation;
6. Subjects have any other medical disorder that may interfere with subjects treatment, assessment or compliance with the protocol.
18 Years
ALL
No
Sponsors
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Sunshine Lake Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Lai Wei, Doctor
Role: STUDY_CHAIR
Beijing Tsinghua Changgeng Hospital
Locations
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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 Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 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
Hainan Provincial People's Hospital
Haikou, Hainan, 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 Municipality, China
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, China
Beijing You'an Hospital,Capital Medical University
Beijing, , China
Countries
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Other Identifiers
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HEC74647/HEC110114-Ⅱ/Ⅲ-01
Identifier Type: -
Identifier Source: org_study_id
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