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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-04-24

Brief Summary

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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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Detailed Description

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Conditions

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HCV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Group

Ravidasvir + Danoprevir + Ritonavir + Ribavirin

Group Type EXPERIMENTAL

Ravidasvir

Intervention Type DRUG

Ravidasvir 200mg tablet administered orally once daily

Danoprevir

Intervention Type DRUG

Danoprevir 100mg tablet administered orally twice daily

Ritonavir

Intervention Type DRUG

Ritonavir 100mg tablet administered orally twice daily

Ribavirin 100 MG

Intervention Type DRUG

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

Placebo Group

Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo

Group Type PLACEBO_COMPARATOR

Ravidasvir Placebo

Intervention Type DRUG

Ravidasvir Placebo tablet administered orally once daily

Danoprevir Placebo

Intervention Type DRUG

Danoprevir Placebo tablet administered orally twice daily

Ritonavir Placebo

Intervention Type DRUG

Ritonavir Placebo tablet administered orally twice daily

Ribavirin Placebo

Intervention Type 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)

Interventions

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Ravidasvir

Ravidasvir 200mg tablet administered orally once daily

Intervention Type DRUG

Danoprevir

Danoprevir 100mg tablet administered orally twice daily

Intervention Type DRUG

Ritonavir

Ritonavir 100mg tablet administered orally twice daily

Intervention Type DRUG

Ribavirin 100 MG

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

Intervention Type DRUG

Ravidasvir Placebo

Ravidasvir Placebo tablet administered orally once daily

Intervention Type DRUG

Danoprevir Placebo

Danoprevir Placebo tablet administered orally twice daily

Intervention Type DRUG

Ritonavir Placebo

Ritonavir Placebo tablet administered orally twice daily

Intervention Type DRUG

Ribavirin Placebo

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)

Intervention Type DRUG

Other Intervention Names

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ASC16 ASC08

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No