Efficacy Study in Removing Excess Iron From the Heart
Tracking Information | |||||||||||||||||
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First Received Date ICMJE | March 15, 2005 | ||||||||||||||||
Last Updated Date | March 13, 2007 | ||||||||||||||||
Start Date ICMJE | December 2002 | ||||||||||||||||
Primary Completion Date | |||||||||||||||||
Current Primary Outcome Measures ICMJE |
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 Measures ICMJE | Same as current | ||||||||||||||||
Change History | Complete list of historical versions of study NCT00105495 on ClinicalTrials.gov Archive Site | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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 Measures ICMJE | Same as current | ||||||||||||||||
Current Other Outcome Measures ICMJE | |||||||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Efficacy Study in Removing Excess Iron From the Heart | ||||||||||||||||
Official Title ICMJE | 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. |
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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. |
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Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase | Phase 4 | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) | |||||||||||||||||
Publications * | |||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||
Enrollment ICMJE | 60 | ||||||||||||||||
Completion Date | October 2004 | ||||||||||||||||
Primary Completion Date | |||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||||||
Ages | 18 Years to 36 Years | ||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Location Countries ICMJE | Greece, Italy | ||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT00105495 | ||||||||||||||||
Other Study ID Numbers ICMJE | LA16-0102 | ||||||||||||||||
Has Data Monitoring Committee | |||||||||||||||||
Responsible Party | |||||||||||||||||
Study Sponsor ICMJE | ApoPharma | ||||||||||||||||
Collaborators ICMJE | |||||||||||||||||
Investigators ICMJE |
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Information Provided By | ApoPharma | ||||||||||||||||
Verification Date | October 2006 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |