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COMPLETEDPHASE2/PHASE3

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.

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.

NCT03362814•Ascletis Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

July 1, 2017

Primary Completion Date

December 12, 2018

Completion Date

April 24, 2019

Last Updated

July 28, 2020

Enrollment

425

ACTUAL participants

Conditions

HCV

Interventions

Ravidasvir

DRUG

Danoprevir

DRUG

Ritonavir

DRUG

Ribavirin 100 MG

DRUG

Ravidasvir Placebo

DRUG

Danoprevir Placebo

DRUG

Ritonavir Placebo

DRUG

Ribavirin Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 28, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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.

Inclusion Criteria

Exclusion Criteria

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