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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis B Virus, Pediatric

Treatments: Drug: Placebo; Drug: Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01079806

AI463-189 ST

Details and patient eligibility

About

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

Enrollment: 180 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

Entecavir

Active Comparator group

Description:

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

Treatment:

Drug: Entecavir

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo