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

Phase 1 Completed 22 enrolled Novartis Pharmaceuticals

Non-randomizedParallel-groupOpen-labelOther

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.

Timeline

Start: 2009-02
Primary completion: 2012-03
Completion: —

Publications

Stein DS, Ke J, Uy G, Bosheva M, Qi Y, Praestgaard J; LDT600A2104 Study Team. Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of telbivudine in children and adolescents with chronic hepatitis B. Antimicrob Agents Chemother. 2013 Sep;57(9):4128-33. doi: 10.1128/AAC.00117-13. Epub 2013 Jun 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Telbivudine	Small molecule	15 mg/kg	Oral
Subject	Telbivudine	Small molecule	25 mg/kg	Oral
Subject	Telbivudine	Small molecule	600 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications