CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
entecavir +2 moredrug
Likely dose
entecavir 0.5mgfrom 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/NCT00940485
NCT00940485Phase 4Completed
CompareCT.gov

A Study on Optimizing HBeAg Seroconversion in HBeAg Positive CHB Patients With Combination or Sequential Treatment of Pegylated Interferon Alpha-2a and Entecavir

Hoffmann-La Roche·interventional·Posted Jul 16, 2009·Updated Mar 25, 2016

In Brief

A Phase 4 clinical trial evaluating entecavir and peginterferon alfa-2a [Pegasys] for Hepatitis B, Chronic. Completed, enrolled 200 participants across 7 sites.

Detailed Summary

This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months.

Study Details

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

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2009
Enrollment StartApr 1, 2009
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.0 years ago

Interventions

entecavirdrug

0.5mg po daily for 8 weeks

entecavirdrug

0.5mg po daily for 48 weeks

peginterferon alfa-2a [Pegasys]drug

180 micrograms sc/week for 48 weeks