Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Virus Genotype1 Infected Subjects.

• Status: Completed
• Trial end date: 2019-04-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of Ravidasvir in combination with Danoprevir/r and ribavirin(RBV) by sustain virologic response 12 (SVR12), in treatment-naive, non-cirrhotic, chronic hepatitis C genotype 1 infected patients.

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

Details

• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.
• Treatments: Lactams; Ribavirin; Ritonavir

Criteria

Inclusion Criteria:

• Infection with Chronic hepatitis C genotype 1confirmed at screening;

• Anti-HCV positive；

• HCV RNA ≥1 × 10000IU / mL;

• Not treated with interferon and / or any other direct-acting antiviral (DAA) drug;

• Non-cirrhotic;

• Voluntarily sign informed consent.

Exclusion Criteria:

• HCV genotypes 2 to 7 or undetectable HCV genotype or mixed HCV genotype;

• Fibroscan detection result > 12.9kPa or Histopathological examination result of patients is with cirrhosis;

• Past or existing evidence of the presence of non-HCV-induced chronic liver disease;

• Previous history of hepatocellular carcinoma, or suspected hepatocellular carcinoma found prior to screening, or suspected abdominal hepatoblastoma at screening or AFP>100ng/mL;

• Anti-HAV (IgM) 、HBsAg 、anti-HEV (IgM) or anti-HIV is positive;

• BMI<18 or≥30 kg/m2;

• ANC<1.5×109/L、PLT<100×109/L、HB<110g/L（female）or<120g/L（male）；INR>1.5；ALT or AST≥5*ULN；TBIL≥2*ULN（DBIL≥ 35%TBIL）；Cr≥1.5*ULN;

• Others as specified in detailed protocol.