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.

Launched by ASCLETIS PHARMACEUTICALS CO., LTD. · Dec 4, 2017

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.