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.
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Participants With Adverse Events by Primary System Organ Class (SOC)
Timeframe: 4 year extension + core 1 year
Change in Liver Iron Concentration (LIC)
Timeframe: Baseline of Core Study to End of Extension Study, up to 5 years.