At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 180 enrolled
Drug / intervention
Entecavir +1 moredrug
Likely dose
Entecavir 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.
A Comparative Study of the Antiviral Efficacy and Safety of Entecavir (ETV) Versus Placebo in Pediatric Subjects With Chronic Hepatitis B Virus (HBV) Infection Who Are HBeAg-Positive
In Brief
A Phase 3 clinical trial evaluating Entecavir and Placebo for Chronic Hepatitis B Virus, Pediatric. Completed, enrolled 180 participants across 44 sites in 14 countries.
Detailed Summary
The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B Virus, Pediatric
CountriesArgentina, Belgium, Canada, Germany, Greece, India, Israel, Poland, Romania, Russia, South Korea, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartJun 2010
Primary CompletionMar 2013
Study CompletionMar 2018
TodayJul 2026
First PostedMar 3, 2010
Enrollment StartJun 30, 2010
Primary CompletionMar 31, 2013
Study CompletionMar 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.3 years ago
Interventions
Entecavirdrug
Tablets/oral solution, 0.015 mg/kg up to 0.5 mg, administered orally, once daily, for 96 to144 weeks, depending on response
Placebodrug
Tablets/oral solution, 0 mg, administered orally, once daily, for 48 to 96 weeks, depending on response