NCT03020082

Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III

A Multi-centered, Open Label, Phase III Study on Efficacy, Safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Ascletis Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Danoprevir	Danoprevir (DNV)administered orally 100mg BID for 12 weeks;
DRUG	Ritonavir	Ritonavir administered orally 100mg BID for 12 weeks;
DRUG	peginterferon alfa-2a	PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;
DRUG	RBV	RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2017-01-13
• Last updated: 2021-03-23
• Results posted: 2021-03-23