CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 150 enrolled
Drug / intervention
peginterferon alfa-2a [Pegasys]drug
Likely dose
peginterferon alfa-2a [Pegasys] 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/NCT01519921
NCT01519921Phase 4Completed
CompareCT.gov

An Open Label Phase IV Multicenter Study for Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Patients With HBeAg Positive Chronic Hepatitis B

Hoffmann-La Roche·interventional·Posted Jan 27, 2012·Updated Apr 21, 2016

In Brief

A Phase 4 clinical trial evaluating peginterferon alfa-2a [Pegasys] for Hepatitis B, Chronic. Completed, enrolled 150 participants across 7 sites.

Detailed Summary

This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.

Study Details

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

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2012
Enrollment StartOct 1, 2005
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.4 years ago

Interventions

peginterferon alfa-2a [Pegasys]drug

Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks