Clinical Trial: Efficacy Study in Removing Excess Iron From the Heart
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized Trial Comparing the Relative Efficacy of Deferiprone to That of Deferoxamine in Removing Excess Cardiac Iron in Thalassemia Major Patients
Brief 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 Summary:
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.
Sponsor: ApoPharma
Current Primary Outcome: To determine whether deferiprone exhibits superior efficacy in removing excess iron from the heart compared to that of deferoxamine, as reflected by MRI T2* assessments in the heart in participants treated with either chelator
Original Primary Outcome: Same as current
Current Secondary Outcome: To evaluate the relative efficacy of deferiprone with respect to that of deferoxamine as assessed by serum ferritin concentration and liver iron concentration (LIC)
Original Secondary Outcome: Same as current
Information By: ApoPharma
Dates:
Date Received: March 15, 2005
Date Started: December 2002
Date Completion: October 2004
Last Updated: January 4, 2016
Last Verified: October 2006
