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.

Ascletis Pharmaceuticals Co., Ltd.425 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

425

Conditions

HCV

Interventions

RavidasvirDRUG

Ravidasvir 200mg tablet administered orally once daily

DanoprevirDRUG

Danoprevir 100mg tablet administered orally twice daily

RitonavirDRUG

Ritonavir 100mg tablet administered orally twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking University People's hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

Time frame: Post treatment Week 12

Adverse events leading to permanent discontinuation of study drug

Time frame: baseline to week 12

Secondary Outcomes

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

Time frame: Post treatment Week 4

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

Time frame: Post treatment Week 24

Quatitation change of HCV RNA compared to baseline after treatment

Time frame: Baseline to week 1

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

Time frame: Baseline to week 12

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.

Time frame: End of treatment to post-treatment week 24

Data from ClinicalTrials.gov

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