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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2018-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Chronic Hepatitis B Virus, Pediatric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Entecavir

Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response

Group Type ACTIVE_COMPARATOR

Entecavir

Intervention Type DRUG

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

Placebo

Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Entecavir

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Baraclude BMS-200475

Eligibility Criteria

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Inclusion Criteria

* Males and females, aged 2 to \<18 years
* Hepatitis B surface antigen-positive
* Detectable hepatitis B e (HBe) antigen, and no detectable anti-HBe antibodies
* Alanine aminotransferase (ALT) 1.5 to \<10 times the upper limit of normal at screening and within 8 to 24 weeks prior to screening
* Evidence of the presence of hepatitis B virus DNA at least 4 weeks before screening and \>100,000 copies/mL at screening

Exclusion Criteria

* Any prior therapy with entecavir
* At least 12 weeks of prior therapy with any nucleoside or nucleotide antiviral agent
* Therapy with interferon alpha, thymosin alpha, or nucleototide antiviral agents within 24 weeks of screening
* Coinfection with HIV, hepatitis C virus, or hepatitis D virus
* Decompensated liver disease
* Liver transplant recipients
* Other forms of acute and chronic conditions which may cause increased ALT levels
* Children who were breastfed while their mothers received lamivudine or whose mothers received lamivudine during pregnancy

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No