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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Danoprevir
* Drug: Ritonavir
* Drug: peginterferon alfa-2a
* Drug: RBV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Danoprevir, Ritonavir, Peg-IFN,RBV<br>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. | Drug: Danoprevir<br>* Danoprevir (DNV)administered orally 100mg BID for 12 weeks;<br>* Other names: ASC08;Drug: Ritonavir<br>* Ritonavir administered orally 100mg BID for 12 weeks;<br>Drug: peginterferon alfa-2a<br>* PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;<br>* Other names: Peg-IFN;Drug: RBV<br>* RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.<br>* Other names: Ribasphere®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Danoprevir, non-cirrhotic, Chinese HCV G1, SVR12