Status:
UNKNOWN
Combined Chelation Treatment With Deferiprone and Deferoxamine in Thalassemia Major
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborating Sponsors:
CORDA, The Heart Charity
The Cooley's Anemia Foundation,
Conditions:
Beta-Thalassemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Detailed Description
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 tr...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00103753
Start Date
May 1 2004
End Date
June 1 2005
Last Update
June 24 2005
Active Locations (1)
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1
Ospedale Microcitemico, Via Jenner
Cagliari, Sardinia, Italy, 09121