Study of antaitavir hasophate capsules plus yiqibuvir for Chronic Hepatitis C

The company Sunshine Lake Pharma Co., Ltd is enrolling patients into the clinical trial investigating Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C.

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

The trial is designed to enroll male and female 18 Years and older.

The study start date is June 21, 2021.

Inclusion Criteria: 1. Willing and able to provide written informed consent; 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: 1. Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage); 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.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT05395416.

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