CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 236 enrolled
Drug / intervention
Pegylated-interferon Alfa-2a +1 moredrug
Likely dose
Pegylated-interferon 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.

Search/NCT00483938
NCT00483938Phase 3Completed

The Individualized Management With Pegasys and Ribavirin Offering Viral Eradication (IMPROVE) Trial

Hoffmann-La Roche·interventional·Posted Jun 8, 2007·Updated Jan 23, 2017

In Brief

A Phase 3 clinical trial evaluating Pegylated-interferon Alfa-2a and Ribavirin for Hepatitis C, Chronic. Completed, enrolled 236 participants across 23 sites in 2 countries.

Detailed Summary

This study will compare the efficacy and safety of treatment with pegylated-interferon alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than or equal to (\>=) 2 log10 drop in HCV-RNA. Participants will be randomized to receive pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400 milligram \[mg\]) orally daily for the specified duration, followed by 24 weeks of treatment-free follow-up. Participants with detectable HCV-RNA and less than (\<) 2 log10 drop in HCV-RNA at week 12 will discontinue therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 8, 2007
Enrollment StartJun 1, 2007
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 19.1 years ago

Interventions

Pegylated-interferon Alfa-2adrug

Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.

Ribavirindrug

Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.