CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 enrolled
Drug / intervention
PegIFN-2b (Sylatron®)drug
Likely dose
PegIFN-2b (Sylatron®) 4.5 μgfrom 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/NCT01432535
NCT01432535Phase 1Completed
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A Single Dose Study to Assess Pharmacokinetics of SCH 54031 in Patients With Renal Impairment (P05655)

Merck Sharp & Dohme LLC·interventional·Posted Sep 13, 2011·Updated Apr 7, 2017

In Brief

A Phase 1 clinical trial evaluating PegIFN-2b (Sylatron®) for Renal Insufficiency. Completed, enrolled 25 participants.

Detailed Summary

This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b (Sylatron®) in healthy participants to that in participants with moderate to severe impairment of kidney function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Insufficiency
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 13, 2011
Enrollment StartNov 1, 2011
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.8 years ago

Interventions

PegIFN-2b (Sylatron®)drug

Single 4.5 μg/kg dose