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NCT00907894 Clinical Trial

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

Chronic Hepatitis B Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00907894
Other study ID # CLDT600A2104
Secondary ID EudraCT 2007-006
Status Completed
Phase Phase 1
First received
Last updated
Start date February 2009

Study information
Verified date September 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LDT600 (Telbivudine)
LDT600 (Telbivudine)

Locations
Country Name City State
Belgium Novartis Investigative Site Brussels
Germany Novartis Investigator Site Frankfurt
Germany Novartis Investigator Site Starnberg
Germany Novartis Investigator Site Wuppertal
Philippines Novartis Investigator Site Manila
Philippines Novartis Investigator Site Quezon City
United Kingdom Novartis Investigator Site Birmingham

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Germany,  Philippines,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC) To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and adolescent patients (2-18 years of age) with chronic hepatitis B (CHB) infection. 6 days
Secondary Safety assessments will include vital signs, ECG and incidence of adverse events and serious adverse events. To evaluate the safety and tolerability of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection 6 days
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