A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase

Inclusion Criteria:

- Positive for HBsAg and HBeAg for more than 6 months prior to baseline

- Detectable HBV-DNA (>20,000 IU/mL) as measured by polymerization chain reaction (PCR)
or hybridization on at least 2 occasions at least one month apart with the latest
determination obtained less than or equal to (
- Compensated liver disease (Child-Pugh Class A clinical classification)

- Either Liver biopsy performed within 2 years prior to baseline showing no or minimal
fibrosis (Liver Biopsy Scores and stable normal ALT levels (less than or equal to
upper limit of normal [ULN]) during the 6 months leading up to baseline (including two
separate occasions at least 1 month apart over the 6 months prior to baseline).
Screening ALT levels must be normal ( during the 1 year leading up to baseline (including three separate occasions at least
1 month apart over the 1 year prior to baseline) and no signs of hepatocellular
carcinoma (HCC), advanced fibrosis/cirrhosis, or splenomegaly on liver abdominal
ultrasound at screening. Screening ALT levels must be normal (
Exclusion Criteria:

- Participants who have received investigational drugs or licensed treatments with anti
HBV activity (Exception: Participants who have had a limited [ acyclovir for herpetic lesions more than 1 month before the study baseline visit are
not excluded)

- Participants who have participated in any other clinical trial or who have received
any investigational drug within 6 months prior to baseline

- Known hypersensitivity to interferon (IFN), pegylated interferon-alfa-2a or lamivudine
or entecavir

- Positive test results at screening for hepatitis A virus Immunoglobulin M (IgM)
antibody (Ab), anti-hepatitis C virus (HCV) Ab, anti- hepatitis D (HDV) Ab or
anti-human immunodeficiency virus (HIV) Ab

- Decompensated liver disease (e.g., Child-Pugh Class B or C clinical classification or
clinical evidence such as ascites or varices)

- Advanced fibrosis or cirrhosis

- Suspicion of HCC on liver abdominal ultrasound (all patients to have liver abdominal
ultrasound within 6 months prior to baseline)

- History or other evidence of a medical condition associated with chronic liver disease
other than CHB including metabolic liver diseases such as hemochromatosis, Wilson's
disease or alpha-1 anti-trypsin deficiency

- Active substance abuse within 6 months prior to screening

- Sexually active females of childbearing potential and sexually active males who are
not willing to utilize reliable contraception during treatment and for 90 days
following the end of treatment

- Females who are pregnant or who are breastfeeding (females of childbearing potential
who have a positive urine or serum pregnancy test result within 24 hours of baseline
are excluded)