Status:
COMPLETED
Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C
Lead Sponsor:
Sunshine Lake Pharma Co., Ltd.
Conditions:
Chronic HCV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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) infecti...
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, prov...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2023
Estimated Enrollment :
514 Patients enrolled
Trial Details
Trial ID
NCT05395416
Start Date
June 21 2021
End Date
April 11 2023
Last Update
May 14 2025
Active Locations (36)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
2
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
3
Anhui Provincial Hospital
Hefei, Anwei, China
4
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044