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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2,Multicenter,Open-Label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis GT1

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Danoprevir
* Drug: Ritonavir
* Drug: peginterferon alfa-2a
* Drug: Ribavirin (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) ; Positive HCV antibody Serum HCV RNA of ≥ 1 × 104 IU/mL Hepatitis C virus GT1 Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV The liver biopsy methods in the protocol (non-cirrhosis is defined as: Metavir score ˂ 4), or as determined by Fibroscan defined as: ˂ 14.6 kPa. Patients who have not obtained a liver biopsy or Fibroscan in the last 1 years will have a study related Fibroscan performed in order to confirm the diagnosis 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, including but not limited to, autoimmune hepatitis, α-1-antitrypsin deficiency, C282Y homozygous hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy Patients with a history of liver cell cancer, screening before or screening suspected hepatocellular carcinoma (HCC) patients, or imaging studies found suspicious nodules, or AFP > 50 ng/mL Positive hepatitis A antibody，positive hepatitis B surface antigen，syphilis antibody or HIV antibody at screening 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 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. | Drug: Danoprevir<br>* Danoprevir (DNV) 100mg tablet administered orally twice daily<br>* Other names: ASC08;Drug: Ritonavir<br>* Ritonavir 100mg tablet administered orally twice daily<br>Drug: peginterferon alfa-2a<br>* PegIFN subcutaneous injection at 180 mcg weekly<br>* Other names: PegIFN;Drug: Ribavirin (RBV)<br>* Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)<br>* Other names: Ribasphere®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment | SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration | 24 weeks | 

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