The Chariot Study

Phase 4

Completed

• Conditions: Chronic Hepatitis C genotype 1; Inflammatory and Immune System - Liver

• Registration Number: ACTRN12605000488606
• Lead Sponsor: Roche Products Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 816

Inclusion Criteria

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.

Exclusion Criteria

Standard exclusion criteria for pegylated interferon and ribavirin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of peginterferon alfa-2a (Pegasys) plus ribavirin combination therapy induction dosing versus no induction dosing on the clearance of HCV viremia in patients with chronic hepatitis C (CHC) infected with HCV genotype 1.[24 weeks after completion of a 48 week treatment period (sustained virological response).]

Secondary Outcome Measures

Name	Time	Method
To compare the effect of Pegasys plus ribavirin induction dosing versus no induction dosing on serum ALT.[24 weeks after completion of a 48 week treatment period (sustained biochemical response).];To compare the effect of Pegasys plus ribavirin induction dosing versus no induction dosing on the combined endpoint of clearance of HCV viraemia and normalization of serum ALT.[24 weeks after completion of a 48 week treatment period (sustained virological and biochemical response).];To evaluate the effect of induction dosing versus no induction dosing on the reduction of HCV viremia.[After 4, 8, 12, 24 weeks of treatment with Pegasys plus ribavirin.];To compare the safety of Pegasys plus ribavirin induction dosing versus no induction dosing.[];To evaluate the predictors of sustained virological response to treatment with Pegasys plus ribavirin induction dosing versus no induction dosing.[]