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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00907894

Enrollment

Registered

2009-05-25

Start date

2009-02-28

Completion date

Unknown

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis B,, telbivudine,, pharmacokinetics,, safety,, tolerability,, pediatric

Brief 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.

Interventions

DRUGLDT600 (Telbivudine)

LDT600 (Telbivudine)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

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/

Design outcomes

Primary

Measure	Time frame	Description
LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC)	6 days	To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and adolescent patients (2-18 years of age) with chronic hepatitis B (CHB) infection.

Secondary

Measure	Time frame	Description
Safety assessments will include vital signs, ECG and incidence of adverse events and serious adverse events.	6 days	To evaluate the safety and tolerability of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection

Countries

Belgium, Germany, Philippines, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026