Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C
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
1 other identifier
interventional
514
1 country
36
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2021
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 21, 2021
CompletedFirst Submitted
Initial submission to the registry
May 20, 2022
CompletedFirst Posted
Study publicly available on registry
May 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2023
CompletedMay 14, 2025
May 1, 2022
1.8 years
May 20, 2022
May 12, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Sustained virologic response at 12 weeks after end of treatment (SVR12)
Percentage of subjects with plasma HCV RNA not detected or below the lower limit of quantitation (15 IU/mL)
Posttreatment Week 12
Type and frequencies of Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Up to posttreatment week 24
Secondary Outcomes (2)
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
Study Arms (3)
HEC74647PA+HEC110114 100 mg/200 mg
EXPERIMENTALPhase 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
EXPERIMENTALPhase 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 COMPARATORPhase III: HCV GT 1-6 participants were medicated with HEC74647PA Placebo Capsules once daily and HEC110114 Placebo tablets once daily
Interventions
administered orally once daily for 12 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
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, 100044, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102200, 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
Study Officials
- STUDY CHAIR
Lai Wei, Doctor
Beijing Tsinghua Changgeng Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2022
First Posted
May 27, 2022
Study Start
June 21, 2021
Primary Completion
April 11, 2023
Study Completion
April 11, 2023
Last Updated
May 14, 2025
Record last verified: 2022-05