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Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients

Myelodysplastic Syndrome Clinical Trial

Official title:
An Open Label, Safety and Tolerability Study of Deferasirox for Treatment of Transfusional Iron Overload in Low-risk and INT-1, Myelodysplastic Patients Using Serum Ferritin Monitoring

Clinical Trial Summary

The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.

Clinical Trial Description

Study entry requires a diagnosis of low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria and serum ferritin ≥ 1000 ng/mL. Patients must have had at least 30 prior red blood cell transfusions. Deferasirox will be administered at an initial dose of 20 mg/kg orally once per day. Patient transfusion history and at least three complete blood count (CBC) values must be available for the 12 weeks prior to study registration for patients with MDS and chronic iron overload from blood transfusions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00110266
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date July 25, 2005
Completion date March 28, 2008
View Details
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