Efficacy Study in Removing Excess Iron From the Heart
Drug: Ferriprox (deferiprone)
Drug: Desferal (deferoxamine)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Trial Comparing the Relative Efficacy of Deferiprone to That of Deferoxamine in Removing Excess Cardiac Iron in Thalassemia Major Patients|
- 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
- To evaluate the relative efficacy of deferiprone with respect to that of deferoxamine as assessed by serum ferritin concentration and liver iron concentration (LIC)
|Study Start Date:||December 2002|
|Estimated Study Completion Date:||October 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105495
|1st Department of Pediatrics, Athens University, Aghia Sophia Children's Hospital|
|Athens, Greece, 11527|
|Aghia Sophia Children's Hospital|
|Athens, Greece, 11527|
|Ospedale Regionale Microcitemie, Dipartimento di Scienze|
|Cagliari, Sardegna, Italy, 09100|
|Dipartimento di Scienze e Dell' Adolescenza, University of Turin|
|Turin, Italy, 10126|
|Principal Investigator:||Renzo Galanello, M.D.||Ospedale Regionale Microcitemie, Cagliari, Italy|
|Principal Investigator:||Antonio Piga, M.D.||Dipartimento di Scienze Pediatriche e Dell'Adolescenza, University of Turin, Turin, Italy|
|Principal Investigator:||Markissia Karagiorga, M.D.||Aghia Sophia Children's Hospital, Athens, Greece|
|Principal Investigator:||Vassilis Ladis, M.D.||1st Department of Pediatrics, Athens University, Aghia Sophia Children's Hospital, Athens, Greece|