Combined Chelation Treatment With Deferiprone and Deferoxamine in Thalassemia Major
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
1 other identifier
interventional
65
1 country
1
Brief Summary
Thalassemia major is a genetic disorder affecting hemoglobin synthesis, rendering individuals dependent upon lifelong blood transfusions. Consequently, iron overload occurs and patients have shortened life expectancy with the most common cause of death being heart failure. This trial tests whether the combination of traditional therapy (deferoxamine) with a newer drug (deferiprone) will prove more effective in removing cardiac iron than deferoxamine alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2004
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 14, 2005
CompletedFirst Posted
Study publicly available on registry
February 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedJune 24, 2005
February 1, 2005
February 14, 2005
June 23, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myocardial T2*
Secondary Outcomes (7)
Liver T2*
LV and RV volumes and function in systole and diastole
Brachial artery reactivity
B-type natriuretic peptide
Patient compliance
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Beta thalassemia major
- Maintaining pre-transfusion hemoglobin of 9 g/dL
- Myocardial T2\* between 8 and 20 ms
- Ability to give informed consent
- Male or female
- Age \>18 years
- Any ejection fraction
- Confirmation of effective contraception throughout the trial (both men and women)
You may not qualify if:
- Implant incompatible with MR (magnetic resonance), such as pacemaker, claustrophobia, or other condition making CMR impossible or inadvisable
- Neutropenia within 12 months (ANC \<1.5 x10\^9/L), unless normal at screening
- Thrombocytopenia within 12 months (\<50 x10\^9/L), unless normal at screening
- Liver enzymes \> 3 times upper limit of normal
- Patients who have previously received deferiprone for a total of more than 6 months over the last 5 years.
- Patients with a previous reaction to deferiprone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal Brompton & Harefield NHS Foundation Trustlead
- CORDA, The Heart Charitycollaborator
- The Cooley's Anemia Foundation,collaborator
- Apotex Inc.collaborator
- The UK Thalassemia Societycollaborator
Study Sites (1)
Ospedale Microcitemico, Via Jenner
Cagliari, Sardinia, 09121, Italy
Related Publications (1)
Tanner MA, Galanello R, Dessi C, Smith GC, Westwood MA, Agus A, Pibiri M, Nair SV, Walker JM, Pennell DJ. Combined chelation therapy in thalassemia major for the treatment of severe myocardial siderosis with left ventricular dysfunction. J Cardiovasc Magn Reson. 2008 Feb 25;10(1):12. doi: 10.1186/1532-429X-10-12.
PMID: 18298856DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 14, 2005
First Posted
February 15, 2005
Study Start
May 1, 2004
Study Completion
June 1, 2005
Last Updated
June 24, 2005
Record last verified: 2005-02