CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 671 enrolled
Drug / intervention
pegylated interferon alpha-2b +2 moredrug
Likely dose
pegylated interferon alpha-2b 1.0 mcg/kgfrom 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/NCT00536263
NCT00536263Phase 3Completed
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An Open-label, Randomized Study of PegIntron in the Treatment of HBeAg Positive Chronic Hepatitis B Patients

Merck Sharp & Dohme LLC·interventional·Posted Sep 27, 2007·Updated Apr 7, 2017

In Brief

A Phase 3 clinical trial evaluating pegylated interferon alpha-2b for Hepatitis B, Chronic. Completed, enrolled 671 participants.

Detailed Summary

The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks. This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks after their treatment ends.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 27, 2007
Enrollment StartSep 1, 2007
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.8 years ago

Interventions

pegylated interferon alpha-2bdrug

1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks

pegylated interferon alpha-2bdrug

1.5 mcg/kg S.C. QW for 24 weeks

pegylated interferon alpha-2bdrug

1.5 mcg/kg S.C. QW for 48 weeks