A Phase IV, Randomised, Multi-centre, Efficacy and Safety Study Examining the Effect of Induction Dosing with the combination of peginterferon Alfa-2a and Ribavirin in Patients with Chronic Hepatitis C Infected with Hepatitis C Genotype 1.

Roche Products Pty Ltd0 个研究点目标入组 816 人开始时间: 2005年9月23日最近更新: 2020年1月13日

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•Serologic evidence of chronic hepatitis C infection (repeatedly anti-HCV positive and/or HCV-RNA positive)- Infection with HCV; meets section 100 criteria for treatment with Pegasys RBV- Compensated liver disease, Child Pugh score <7- Quantifiable Serum HCV-RNA - Patients who are naive to any hepatitis C therapy (i.e. have not been previously treated with an interferon or with IFN plus ribavirin) - Chronic liver disease consistent with chronic hepatitis C infection on a biopsy obtained within the past 18 months as judged by a local pathologist. (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy. The section 100 criteria states that in patients with coagulation disorders considered severe enough to prevent liver biopsy, evidence of abnormal serum ALT levels is required.) - Patients with transition to cirrhosis or cirrhosis (Metavir (or equivalent index) stage 3 or 4) must have an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma and a serum AFP <100 ng/mL within 2 months of randomisation- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drugAll fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end.

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