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

• Conditions: Chronic hepatitis B; MedDRA version: 14.1Level: LLTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2007-006218-40-Outside-EU/EEA
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-09
• Last Update Posted: 3 July 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

•Children and adolescents patients
•HBsAg seropositive
Other protocol-defined inclusion/exclusion criteria may apply.

Are the trial subjects under 18? yes
Number of subjects for this age range: 28
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and adolescent patients (2-18 years of age) with chronic hepatitis B infection<br>- To evaluate the safety and tolerability of LDT600 in pediatric and adolescent patients with CHB infection;Secondary Objective: ;Primary end point(s): - LDT600 plasma concentration and PK parameters of exposure (Cmax and AUC)<br>- Incidence of AEs and SAEs

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To evaluate the safety and tolerability of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection