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Completed

NCT Number: NCT03362814

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.

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.

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Key information

Conditions

HCV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Peking University People's hospital

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ravidasvir

Drug

Ravidasvir 200mg tablet administered orally once daily

Other names: ASC16

Danoprevir

Drug

Danoprevir 100mg tablet administered orally twice daily

Other names: ASC08

Ritonavir

Drug

Ritonavir 100mg tablet administered orally twice daily

Ribavirin 100 MG

Drug

Ribavirin tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(<75kg = 1000mg and ≥75kg = 1200mg)

Ravidasvir Placebo

Drug

Ravidasvir Placebo tablet administered orally once daily

danoprevir placebo

Drug

Danoprevir Placebo tablet administered orally twice daily

ritonavir placebo

Drug

Ritonavir Placebo tablet administered orally twice daily

Ribavirin Placebo

Drug

Ribavirin Placebo tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(<75kg = 5 tablets and ≥75kg = 6 tablets)

Primary outcomes

  1. Percentage of Participants achieving sustained Virologic response 12 weeks after EOT

    Time frame: Post treatment Week 12

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks after cessation of therapy

  2. Adverse events leading to permanent discontinuation of study drug

    Time frame: baseline to week 12

Secondary outcomes

  1. Percentage of Participants achieving sustained Virologic response 4 weeks after EOT

    Time frame: Post treatment Week 4

    SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks after cessation of therapy

  2. Percentage of Participants achieving sustained Virologic response 24 weeks after EOT

    Time frame: Post treatment Week 24

    SVR24 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 24 weeks after cessation of therapy

  3. Quatitation change of HCV RNA compared to baseline after treatment

    Time frame: Baseline to week 1

  4. Percentage of participants with viral breakthrough

    Time frame: 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

  5. Percentage of participants with viral relapse

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ascletis Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Dec 5, 2017
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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