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

Ascletis

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C

Treatments: Drug: Danoprevir; Drug: peginterferon alfa-2a; Drug: RBV; Drug: Ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT03020082

ASC08201503

Details and patient eligibility

About

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.

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to provide written informed consent
• Chronic HCV infection (≥ 6 months)
• Serum HCV RNA of ≥ 1 × 104 IU/mL are documented
• Hepatitis C virus GT1
• Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
• Non-cirrhosis patients: Non-cirrhosis is defined (1)Fibroscan defined as: ˂ 14.6 kPa during screening period, or liver biopsy determined 1 year before recruiting (Metavir score ˂ 3);(2) during screening period 9.6<Fibroscan indicator ≤12.9, liver biopsy need to confirm non-cirrhosis.
• Others as specified in the detailed protocol

Exclusion criteria

• Patients with Fibroscan detection value > 12.9 kPa, or histologic examination for liver cirrhosis patients
• Presence or history of non-hepatitis C chronic liver disease (e.g. HH, AIH, Wilson's disease, α1 antitrypsin deficiency, drug- or toxin-induced liver disease)
• History of liver cell cancer, or suspected hepatocellular carcinoma (HCC) patients before or during screening , or imaging studies found suspicious nodules, or AFP > 50 ng/mL
• Positive hepatitis A antibody，positive hepatitis B surface antigen，HIV antibody
• Presence or history of nervous system diseases and/or mental illness, inability to control oneself or express oneself.
• Patients with obvious cardiovascular dysfunction
• Pregnant or nursing female, nor unwilling to take reliable contraception
• Others as specified in the detailed protocol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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141 participants in 1 patient group

Danoprevir, Ritonavir, Peg-IFN,RBV

Experimental group

Description:

Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks.

Treatment:

Drug: RBV

Drug: peginterferon alfa-2a

Drug: Danoprevir

Drug: Ritonavir