At a glance
ClinicalIndex Comparison Record- ✓Chronic hepatitis C infection, genotype 1
- ✓Chronic liver disease consistent with CHC documented on liver biopsy within 36 months (or Australian Section 100 criteria)
- ✓Compensated liver disease
- ✓No prior interferon-based therapy for hepatitis C
- ✕Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of study drug
- ✕Coinfection with hepatitis A, hepatitis B, or HIV
- ✕Chronic liver disease other than hepatitis C
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IV, Randomised, Multicentre, 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
In Brief
A Phase 4 clinical trial evaluating PEG-IFN alfa-2a and Ribavirin for Hepatitis C, Chronic. Completed, enrolled 896 participants across 51 sites in 6 countries.
Detailed Summary
This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection.
Study Details
Timeline
Interventions
PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.