At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 129 enrolled
Drug / intervention
peginterferon alfa-2a +1 moredrug
Likely dose
peginterferon alfa-2a 180 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Trial Comparing the Sustained Virological Response in Terms of Expression Profile of IL- 28B in Genotype 1 HCV-Infected Treatment-Naïve Subjects With Chronic Hepatitis C on Pegasys® (Peginterferon Alfa-2A) Plus Copegus® (Ribavirin)
In Brief
A Phase 4 clinical trial evaluating peginterferon alfa-2a and ribavirin [Copegus] for Hepatitis C, Chronic. Completed, enrolled 129 participants across 15 sites.
Detailed Summary
This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesBrazil
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2011
First PostedOct 2011
Primary CompletionNov 2012
TodayJul 2026
First PostedOct 6, 2011
Enrollment StartFeb 1, 2011
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.7 years ago
Interventions
peginterferon alfa-2adrug
180 mcg sc weekly, 48 weeks
ribavirin [Copegus]drug
1'000 or 1'200 mg orally daily, 48 weeks