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.

Phase 2

Completed

• Conditions: HCV
• Interventions: Drug: Ravidasvir; Drug: Ravidasvir Placebo; Drug: Danoprevir; Drug: Danoprevir Placebo; Drug: Ritonavir; Drug: Ritonavir Placebo; Drug: Ribavirin 100 MG; Drug: Ribavirin Placebo

• Registration Number: NCT03362814
• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.

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-cirrhotic, chronic hepatitis C genotype 1 infected patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2017-11
• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-05
• Primary Completion: 2018-12-12
• Study Completion: 2019-04-24
• Last Update Submitted: 2020-07-25
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Ravidasvir	Ravidasvir + Danoprevir + Ritonavir + Ribavirin
Experimental Group	Danoprevir	Ravidasvir + Danoprevir + Ritonavir + Ribavirin
Experimental Group	Ritonavir	Ravidasvir + Danoprevir + Ritonavir + Ribavirin
Experimental Group	Ribavirin 100 MG	Ravidasvir + Danoprevir + Ritonavir + Ribavirin
Placebo Group	Ravidasvir Placebo	Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo
Placebo Group	Ritonavir Placebo	Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo
Placebo Group	Danoprevir Placebo	Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo
Placebo Group	Ribavirin Placebo	Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo

Primary Outcome Measures

Name	Time	Method
Percentage of Participants achieving sustained Virologic response 12 weeks after EOT	Post treatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks after cessation of therapy
Adverse events leading to permanent discontinuation of study drug	baseline to week 12

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants achieving sustained Virologic response 24 weeks after EOT	Post treatment Week 24	SVR24 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 24 weeks after cessation of therapy
Quatitation change of HCV RNA compared to baseline after treatment	Baseline to week 1
Percentage of participants with viral breakthrough	Baseline to week 12	Viral breakthrough was defined as HCV RNA ≥LLOQ after having previously had HCV RNA\< LLOQ while receiving treatment, confirmed with 2 consecutive values
Percentage of participants with viral relapse	End of treatment to post-treatment week 24	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.
Percentage of Participants achieving sustained Virologic response 4 weeks after EOT	Post treatment Week 4	SVR4 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 4 weeks after cessation of therapy

Trial Locations

Locations (1)

Peking University People's hospital; 🇨🇳 Beijing, Beijing, China