HCV Clinical Trial
Official title:
A Phase2/3, Multi-center, Randomized, Double-blind, Placebo-parallel Controlled Study to Investigate the Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Genotype 1 Infected Subjects.
Verified date | November 2017 |
Source | Ascletis Pharmaceuticals Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 425 |
Est. completion date | April 24, 2019 |
Est. primary completion date | December 12, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University People's hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Ascletis Pharmaceuticals Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants achieving sustained Virologic response 12 weeks after EOT | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks after cessation of therapy | Post treatment Week 12 | |
Primary | Adverse events leading to permanent discontinuation of study drug | baseline to week 12 | ||
Secondary | Percentage of Participants achieving sustained Virologic response 4 weeks after EOT | SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks after cessation of therapy | Post treatment Week 4 | |
Secondary | Percentage of Participants achieving sustained Virologic response 24 weeks after EOT | SVR24 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 24 weeks after cessation of therapy | Post treatment Week 24 | |
Secondary | Quatitation change of HCV RNA compared to baseline after treatment | Baseline to week 1 | ||
Secondary | Percentage of participants with viral breakthrough | Viral breakthrough was defined as HCV RNA =LLOQ after having previously had HCV RNA< LLOQ while receiving treatment, confirmed with 2 consecutive values | Baseline to week 12 | |
Secondary | Percentage of participants with viral relapse | Viral relapse was defined as HCV RNA =LLOQ during the post treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values. | End of treatment to post-treatment week 24 |
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