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.

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

425

Participants

Timeline

Start Date

July 1, 2017

Primary Completion Date

December 12, 2018

Study Completion Date

April 24, 2019

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)

Trial Locations (1)

100044

Peking University People's hospital, Beijing

All Listed Sponsors
lead

Ascletis Pharmaceuticals Co., Ltd.

INDUSTRY

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. | Biotech Hunter | Biotech Hunter