A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

Inclusion Criteria:

- Male or female patients, 3 years to <18 years of age at baseline

- Positive HBsAg for more than 6 months

- Positive HBeAg and detectable HBV DNA at screening

- Negative anti-HBs and anti-HBe at screening

- A liver biopsy obtained within the past 2 years prior to baseline (and more than 6
months after the end of previous therapy for hepatitis B) to confirm the presence of
advanced fibrosis or exclude cirrhosis

- Compensated liver disease (Child-Pugh Class A)

- Elevated serum alanine transferase (ALT)

- Normal thyroid gland function at screening

Exclusion Criteria:

- Subjects with cirrhosis

- Subjects must not have received investigational drugs or licensed treatments with
anti-HBV activity within 6 months of baseline. Subjects who are expected to need
systemic antiviral therapy other than that provided by the study at any time during
their participation in the study are also excluded

- Known hypersensitivity to peginterferon

- Positive test results at screening for hepatitis A, hepatitis C, hepatitis D or HIV
infection

- History or evidence of medical condition associated with chronic liver disease other
than chronic hepatitis B

- History or evidence of bleeding from esophageal varices

- Decompensated liver disease (e.g. ascites, Child-Pugh Class B or C)

- History of immunologically mediated disease

- Pregnant or lactating females