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

Novartis Pharmaceuticals22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

LDT600 (Telbivudine)DRUG

LDT600 (Telbivudine)

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Novartis Investigative Site

Brussels, Belgium

Novartis Investigator Site

Frankfurt, Germany

Novartis Investigator Site

Starnberg, Germany

Novartis Investigator Site

Wuppertal, Germany

Outcomes

Primary Outcomes

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.

Time frame: 6 days

Secondary Outcomes

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

Time frame: 6 days

Data from ClinicalTrials.gov

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