Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B

A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Telbivudine (LDT600) in Children and Adolescents With Chronic Hepatitis B

This is a Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection.

Inclusion Criteria:

• Children and adolescents patients
• HBsAg seropositive

Exclusion criteria:

• Decompensated liver disease (Child-Turcotte-Pugh (CTP) Score≥7, Class B and C)
• Prior anti-HBV therapy within 30 days of study drug dosing.

Other protocol-defined inclusion/exclusion criteria may apply.