Status:
COMPLETED
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.
Lead Sponsor:
Ascletis Pharmaceuticals Co., Ltd.
Conditions:
HCV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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-cirrh...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2019
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT03362814
Start Date
July 1 2017
End Date
April 24 2019
Last Update
July 28 2020
Active Locations (1)
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1
Peking University People's hospital
Beijing, Beijing Municipality, China, 100044