CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Pegylated interferon and ribavirindrug
Likely dose
Pegylated interferon and ribavirin 1200 mgfrom 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.

Search/NCT00575224
NCT00575224Phase 4Completed
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Pegasys and Copegus for Asian Patients With Treatment-naive Hepatitis C Genotypes 6, 7, 8, 9: a Phase IV, Randomized, Open-labeled, Multicenter Trial Comparing 24-week vs. 48-week Therapy

Pacific Health Foundation·interventional·Posted Dec 18, 2007·Updated Nov 25, 2009

In Brief

A Phase 4 clinical trial evaluating Pegylated interferon and ribavirin for Chronic Hepatitis C and 3 related conditions. Completed, enrolled 60 participants across 5 sites.

Detailed Summary

The purpose of this research study is to test the safety, tolerability, and effectiveness of the drugs Pegasys and Copegus when used for hepatitis C genotypes 6, 7, 8, and 9. Patients are randomly assigned (by chance) to either Treatment Group A (Pegasys and Copegus for 24 weeks) or Treatment Group B (Pegasys and Copegus for 48 weeks).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C, Asian Americans, Novel Genotypes, Treatment
CountriesUnited States
CollaboratorsHoffmann-La Roche

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 18, 2007
Enrollment StartOct 1, 2004
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 18.5 years ago

Interventions

Pegylated interferon and ribavirindrug

180 ug of peg-IFN per week and 1000-1200 mg of ribavirin per day (weight-dependent). Treatment duration is determined by treatment arm.