Combined Chelation Treatment With Deferiprone and Deferoxamine in Thalassemia Major
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|ClinicalTrials.gov Identifier: NCT00103753|
Recruitment Status : Unknown
Verified February 2005 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : February 15, 2005
Last Update Posted : June 24, 2005
|Condition or disease||Intervention/treatment||Phase|
|Beta-Thalassemia||Drug: deferiprone||Phase 4|
Thalassemia Major (TM) is a hereditary anemia resulting from a single gene defect that results in abnormal red cell production. The survival of affected individuals is dependent upon lifelong blood transfusions. Unfortunately, this causes total body iron overload, and 50% of the patients in the UK are dead by the age of 35. Approximately 70% of these deaths result from heart failure which results as a consequence of cardiac iron toxicity.
A Cardiovascular Magnetic Resonance (CMR) technique (which exploits the fact that T2* signal decay relates to tissue iron) developed at the Royal Brompton Hospital provides a non-invasive and reproducible assessment of cardiac iron. CMR therefore provides a very useful method to assess response to new treatments in this condition. Using cardiac T2* as a primary endpoint, we will investigate whether the oral chelator, deferiprone in combination with traditional treatment (deferoxamine), is superior in removing cardiac iron as compared to deferoxamine alone. This trial will provide the first randomized controlled, double-blinded, evidence for the efficacy of combination treatment in TM.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Randomized, Placebo Controlled, Double Blind Trial of the Effect of Combined Therapy With Deferoxamine and Deferiprone on Myocardial Iron in Thalassemia Major Using Cardiovascular Magnetic Resonance|
|Study Start Date :||May 2004|
|Estimated Study Completion Date :||June 2005|
U.S. FDA Resources
- Myocardial T2*
- Liver T2*
- LV and RV volumes and function in systole and diastole
- Brachial artery reactivity
- B-type natriuretic peptide
- Patient compliance
- Adverse events
- Success of blinding
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103753
|Ospedale Microcitemico, Via Jenner|
|Cagliari, Sardinia, Italy, 09121|