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

NCT01079806 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2019-05-09

Study results available
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Summary

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

Conditions

  • Chronic Hepatitis B Virus, Pediatric

Interventions

DRUG

Entecavir

Tablets/oral solution, 0.015 mg/kg up to 0.5 mg, administered orally, once daily, for 96 to144 weeks, depending on response

DRUG

Placebo

Tablets/oral solution, 0 mg, administered orally, once daily, for 48 to 96 weeks, depending on response

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-03-31
Completion
2018-03-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • Germany
  • Greece
  • India
  • Israel
  • Poland
  • Romania
  • Russia
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01079806 on ClinicalTrials.gov