NCT00235391

Expanded Access of Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload

A Study to Provide Expanded Access of (Exjade®) Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload From Blood Transfusions Who Cannot Adequately be Treated With Other Locally Approved Iron Chelators

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,683 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, non-randomized, multi-center trial designed to provide expanded access of deferasirox to patients with congenital disorders of red blood cells and chronic iron overload from blood transfusions who cannot adequately be treated with locally approved iron chelators.

Conditions

• Thalassemia
• Sickle Cell Disease
• Diamond Blackfan Anemia
• Myelofibrosis

Interventions

Type	Name	Description
DRUG	Deferasirox	125 mg, 250 mg and 500 mg tablets. Dosage was calculated based on participant's body weight. Tablets were dispersed in water, orange or apple juice and taken orally once a day.

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2005-10-10
• Last updated: 2011-06-07
• Results posted: 2011-05-02

Locations

141 sites across 12 countries: United States, Belgium, Canada, Germany, Greece, Italy, Netherlands, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom