drugset / Trial / NCT00390858

A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.

NCT00390858

Phase 2 Completed 40 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed. Patients who successfully completed the main 1 year trial (NCT00390858) were eligible to continue in this extension trial and receive chelation therapy with deferasirox for up to 4 years.

Timeline

Start
2003-09
Primary completion
2008-02
Completion
2008-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Deferasirox Unknown 10 mg/kg Oral