Conditions: Chronic Hepatitis C
Keywords: Danoprevir SVR12 Chinese HCV G1 non-cirrhotic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 70
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.

Detailed description:

Arms:
arm 1: Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg) for 12 weeks.

Interventions: intervention 1: Danoprevir intervention 2: Ritonavir intervention 3: peginterferon alfa-2a intervention 4: Ribavirin (RBV)
Intervention descriptions: intervention 1: Danoprevir (DNV) 100mg tablet administered orally twice daily intervention 2: Ritonavir 100mg tablet administered orally twice daily intervention 3: PegIFN subcutaneous injection at 180 mcg weekly intervention 4: Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)

Protocol document: