Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105495
Status:
COMPLETED
Last Update Posted:
2016-01-05
First Post:
2005-03-15
Brief Title:
Efficacy Study in Removing Excess Iron From the Heart
Sponsor:
ApoPharma
Organization:
ApoPharma
Study Overview
Official Title:
Randomized Trial Comparing the Relative Efficacy of Deferiprone to That of Deferoxamine in Removing Excess Cardiac Iron in Thalassemia Major Patients
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None