Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C

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  • sponsor
    Sunshine Lake Pharma Co., Ltd.
Updated on 4 June 2022


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


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.

Condition Chronic HCV Infection
Treatment Placebo, HEC74647PA+HEC110114
Clinical Study IdentifierNCT05395416
SponsorSunshine Lake Pharma Co., Ltd.
Last Modified on4 June 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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