Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection

Summary

The purpose of the study was to assess the efficacy and safety of telbivudine at a dose of 20 mg/kg up to a maximum of 600 mg q.d. in compensated pediatric HBeAg-positive and negative CHB patients aged 2 to \<18 years with the indication of antiviral CHB treatment. This study was part of the commitments of the pediatric development plan for telbivudine in Europe and US.

Timeline

Start

2014-10-31

Primary completion

2019-01-09

Completion

2019-01-09

Outcome

Missed primary endpoint

Stopped: “Study terminated on the recommendation of an independent Data Monitoring Committee (DMC) subsequent to an interim efficacy analysis for futility.\]”

registry analysis (other test); Telbivudine vs Placebo; p = 1.0000; Mean Difference (Net) -0.30 (95% CI -37.03 to 36.75); Fisher Exact NCT02058108 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Telbivudine	Small molecule	20 mg/kg	Oral
Subject	Telbivudine	Small molecule	600 mg	Oral

Indications