drugset

drugset / Trial / NCT01079806

A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection

NCT01079806 ↗

Phase 3 Completed 180 enrolled Bristol-Myers Squibb

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection

Timeline

Start: 2010-06-30
Primary completion: 2013-03-31
Completion: 2018-03-31

Publications

Jonas MM, Chang MH, Sokal E, Schwarz KB, Kelly D, Kim KM, Ling SC, Rosenthal P, Oraseanu D, Reynolds L, Thiry A, Ackerman P. Randomized, controlled trial of entecavir versus placebo in children with hepatitis B envelope antigen-positive chronic hepatitis B. Hepatology. 2016 Feb;63(2):377-87. doi: 10.1002/hep.28015. Epub 2015 Oct 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Entecavir	Small molecule	0.015 mg/kg	Oral

Indications