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

Novartis

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: LDT600 (Telbivudine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00907894

CLDT600A2104

EudraCT 2007-006218-40

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

Stratum 1

Experimental group

Treatment:

Drug: LDT600 (Telbivudine)

Stratum 2

Experimental group

Treatment:

Drug: LDT600 (Telbivudine)

Stratum 3

Experimental group

Treatment:

Drug: LDT600 (Telbivudine)