CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 27 enrolled
Drug / intervention
peginterferon alfa-2a [Pegasys]drug
Likely dose
peginterferon alfa-2a [Pegasys] 180 microgramsfrom 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/NCT00474955
NCT00474955Phase 4Completed
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Multicenter Open-label Observation Program in Patients With Chronic Hepatitis C and With Chronic Renal Failure (CRF) Receiving Peginterferon Alpha-2a (40 kDa) Pegasys

Hoffmann-La Roche·interventional·Posted May 17, 2007·Updated Jul 25, 2016

In Brief

A Phase 4 clinical trial evaluating peginterferon alfa-2a [Pegasys] for Hepatitis C, Chronic. Completed, enrolled 27 participants across 5 sites.

Detailed Summary

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular filtration rate of \<15mL/min will receive a reduced dose of 135 micrograms weekly. Following 48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesRussia
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 17, 2007
Enrollment StartJul 1, 2007
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 19.1 years ago

Interventions

peginterferon alfa-2a [Pegasys]drug

180 micrograms or 135 micrograms sc weekly for 48 weeks