NCT00303329

Extension Study of Iron Chelation Therapy With Deferasirox in β-thalassemia and Rare Chronic Anemia Patients

Extension Study of Iron Chelation Therapy With Deferasirox in β-thalassemia and Other Patients With Rare Chronic Anemia and Transfusional Iron Overload

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

A 1-year randomized Phase II core trial was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia and other rare chronic anemia 2 years of age and older. Patients who successfully completed the main trial may continue in the extension trial to receive chelation therapy with deferasirox for up to 3 years. Extension was prolonged to 4 years. The objective of this study is to assess the long-term safety and efficacy of deferasirox in these patient groups.

Conditions

• Anemia
• Hemosiderosis

Interventions

Type	Name	Description
DRUG	Deferasirox	Deferasirox available as 125 mg, 250 mg or 500 mg tablets

Timeline

• Start date: 2004-03-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-03-16
• Last updated: 2011-05-09
• Results posted: 2011-05-09

Locations

28 sites across 7 countries: United States, Belgium, Canada, France, Germany, Italy, United Kingdom