Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II
Phase 2
Completed
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT03020004
- Lead Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Danoprevir,Ritonavir, Peg-IFN,RBV Ribavirin (RBV) 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. Danoprevir,Ritonavir, Peg-IFN,RBV Danoprevir 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. Danoprevir,Ritonavir, Peg-IFN,RBV Ritonavir 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. Danoprevir,Ritonavir, Peg-IFN,RBV peginterferon alfa-2a 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.
- Primary Outcome Measures
Name Time Method Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment 24 weeks SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration
- Secondary Outcome Measures
Name Time Method