Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III
Phase 3
Completed
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT03020082
- Lead Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 141
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Danoprevir, Ritonavir, Peg-IFN,RBV Danoprevir 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. Danoprevir, Ritonavir, Peg-IFN,RBV Ritonavir 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. Danoprevir, Ritonavir, Peg-IFN,RBV peginterferon alfa-2a 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. Danoprevir, Ritonavir, Peg-IFN,RBV RBV 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.
- Primary Outcome Measures
Name Time Method Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) 12 weeks
- Secondary Outcome Measures
Name Time Method