NCT00105495

Efficacy Study in Removing Excess Iron From the Heart

Randomized Trial Comparing the Relative Efficacy of Deferiprone to That of Deferoxamine in Removing Excess Cardiac Iron in Thalassemia Major Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: ApoPharma · Industry
• Sex: All
• Age: 18 Years – 36 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether deferiprone has superior efficacy in removing excess iron from the heart when compared with deferoxamine.

Detailed description

This study is a multi-center, randomized, open-label, controlled clinical trial. The study population is participants with thalassemia major who are receiving regular chelation therapy with deferoxamine. A total of sixty (60) participants will be enrolled among the investigative sites. The primary objective of this study is to determine whether deferiprone exhibits superior efficacy in removing excess iron from the heart compared to that of the standard therapy, deferoxamine. The secondary objective is to evaluate the relative efficacy of deferiprone with respect to that of deferoxamine as assessed by serum ferritin concentration and liver iron concentration. The primary efficacy measure in this study will be the participants' cardiac iron status, as determined by heart MRI T2\* assessments. The secondary efficacy measure will be by serum ferritin concentration and liver iron concentration. This will be measured by the Superconducting Quantum-Interference Device (SQUID) BioSusceptometer. The duration of treatment is 12 months.

Conditions

• Thalassemia Major
• Hemosiderosis

Interventions

Type	Name	Description
DRUG	Ferriprox (deferiprone)
DRUG	Desferal (deferoxamine)

Timeline

• Start date: 2002-12-01
• Completion: 2004-10-01
• First posted: 2005-03-16
• Last updated: 2016-01-05

Locations

4 sites across 2 countries: Greece, Italy