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

• Status: Recruiting
• Trial end date: 2022-12-20
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Criteria

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.