Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection

Inclusion Criteria:

- Clinical history compatible with compensated chronic hepatitis B

- Documented compensated chronic hepatitis B defined by the following:

oPositive serum HBsAg at screening and at least one other documentation of HBsAg positive
at least 6 months prior to screening oFor HBeAg positive patients at screening,
significant biologic and/or histologic signs of disease activity following EASL guidelines
recommendations for CHB pediatric patients (serum HBV DNA level ≥ 5 log10 copies/mL (or 20
000 IU/mL) (COBAS Taqman®) at screening ; serum ALT ≥ 1.5×ULN and < 10×ULN (pediatric ULN)
for two times during the screening period or within 6 months prior to screening oFor HBeAg
negative patients at screening, significant biologic and/or histologic signs of disease
activity following EASL guidelines recommendations for CHB pediatric patients (serum HBV
DNA level ≥ 4 log10 copies/mL (or 2 000 IU/mL) (COBAS Taqman®) at screening) ; serum ALT ≥
1.0 ×ULN and < 10×ULN (pediatric ULN) for two times during the screening period or within
12 months prior to screening)

Exclusion Criteria:

- Patients with acute or chronic infection of HCV, HDV, HIV, or with acute infection of
HAV, HEV, CMV, EBV, or HSV.

- Patient has received treatment of interferon or any other immunomodulatory agents
within the last 12 months prior to screening or any nucleoside or nucleotide drugs or
other anti-CHB treatment (approved or investigational) at any time before screening

- Patient has a medical condition that requires frequent use of systemic acyclovir or
famciclovir, systemic corticosteroids, potentially hepatotoxic drugs or nephrotoxic
drugs or chemotherapy

- Patient has one or more additional known primary or secondary causes of liver
disease, other than CHB; has a decompensated liver disease ; is a Liver transplant
recipient or organ or bone marrow transplant recipient.

- History of any other acute or chronic medical condition (that in the opinion of the
investigator would make the patient unsuitable for inclusion into the study.

- Patient has a history of myopathy, myositis, persistent muscle weakness or persistent
high serum CK levels (≥7×ULN), any muscular disease

- Patient receiving any drugs potentially associated with myopathy within 3 months
prior to screening

- Any other clinical significant disease, condition or abnormality, unrelated to their
HBV infection at screening, as assessed by the investigator