At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 64 enrolled
Drug / intervention
Entecavirdrug
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.
Evaluation of the Pharmacokinetics, Safety, Tolerability and Efficacy of Entecavir (ETV) in Pediatric Subjects With Chronic Hepatitis B Virus (HBV) Infection Who Are HBeAg-Positive
In Brief
A Phase 2 clinical trial evaluating Entecavir for Hepatitis B, Chronic. Completed, enrolled 64 participants across 19 sites in 8 countries.
Detailed Summary
The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic
CountriesArgentina, Belgium, Brazil, Canada, South Korea, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2007
Enrollment StartJun 2007
Primary CompletionAug 2013
Study CompletionSep 2017
TodayJul 2026
First PostedJan 18, 2007
Enrollment StartJun 30, 2007
Primary CompletionAug 31, 2013
Study CompletionSep 4, 2017
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 19.5 years ago
Interventions
Entecavirdrug
Tablets / Oral Solution, Oral, Naïve: 0.015 mg/kg up to 0.5 mg; Experienced: 0.030 mg/kg up to 1 mg, once daily, 48 - 120 weeks depending on response