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

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 nucleotide 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