The Chariot Study

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000488606

Enrollment

896

Registered

2005-09-23

Start date

2009-02-02

Completion date

2009-02-02

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the study is to compare the effectiveness of two treatment regimens in clearing the Hepatitis C Virus in patients infected with Hepatitis C genotype 1. The study aims to determine whether a higher dose of pegylated interferon given in combination with ribavirin for the first 12 weeks of therapy results in a higher rate of viral clearance and whether it is safe and tolerable.

Interventions

Pegylated interferon alfa 2a and ribavirin for 48 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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.

Outcome results