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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Telbivudine

Criteria

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.