At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 60 enrolled
Drug / intervention
Entecavir and peginterferondrug
Likely dose
Entecavir and peginterferon 0.015 mg/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.
Clinical Trial of Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic HBV Infection (HBRN)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Jun 8, 2011·Updated May 26, 2022
In Brief
A Phase 3 clinical trial evaluating Entecavir and peginterferon for Hepatitis B. Completed, enrolled 60 participants across 7 sites in 2 countries.
Detailed Summary
The purpose of this study is to determine the safety and efficacy of treatment using a combination of drugs (entecavir and pegylated interferon) in children ages 3-\<18 years old with immunotolerant chronic hepatitis B.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartSep 2012
Primary CompletionDec 2016
TodayJul 2026
First PostedJun 8, 2011
Enrollment StartSep 1, 2012
Primary CompletionDec 23, 2016
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 15.1 years ago
Interventions
Entecavir and peginterferondrug
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 µg/1.73m2 subcutaneously once weekly for 40 weeks beginning 8 weeks after entecavir monotherapy).