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.

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.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 425 (actual)
• Sponsor: Ascletis Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-12-12
• Completion: 2019-04-24
• First posted: 2017-12-05
• Last updated: 2020-07-28

Locations

1 site across 1 country: China