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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.

NCT03362814 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2020-07-28

No results posted yet for this study

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.

Conditions

  • HCV

Interventions

DRUG

Ravidasvir

Ravidasvir 200mg tablet administered orally once daily

DRUG

Danoprevir

Danoprevir 100mg tablet administered orally twice daily

DRUG

Ritonavir

Ritonavir 100mg tablet administered orally twice daily

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)

DRUG

Ravidasvir Placebo

Ravidasvir Placebo tablet administered orally once daily

DRUG

Danoprevir Placebo

Danoprevir Placebo tablet administered orally twice daily

DRUG

Ritonavir Placebo

Ritonavir Placebo tablet administered orally twice daily

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)

Sponsors & Collaborators

  • Ascletis Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yahong Chen, Master · Ascletis Pharmaceuticals Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2018-12-12
Completion
2019-04-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03362814 on ClinicalTrials.gov