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

• Status: Completed
• Trial end date: 2018-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Entecavir

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