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

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.
• Treatments: Interferon-alpha; Lactams; Peginterferon alfa-2a; Ribavirin; Ritonavir

Criteria

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