Status:
APPROVED_FOR_MARKETING
Compassionate Use of Deferiprone for Patients With Thalassemia and Iron-Induced Heart Disease
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
ApoPharma
Conditions:
Iron Overload
Eligibility:
All Genders
Brief Summary
Patients who have iron overload due to chronic blood transfusions and have developed heart failure or who are at high risk of heart failure because of the high levels of iron in their hearts, will be ...
Detailed Description
Repeated red cell transfusions lead to transfusional iron overload because the body lacks an efficient mechanism to excrete excess iron. Without treatment, iron accumulates in the liver, heart and end...
Eligibility Criteria
Inclusion
- Transfusional iron overload
- Overt cardiac failure or significant arrhythmia, OR high risk of developing cardiac failure as determined by T2\* \< 10 ms by magnetic resonance imaging (MRI)
- Signed consent form
- Patient regularly followed at The Children's Hospital of Philadelphia
- Unwillingness to participate in, or lack of suitability for, a clinical trial providing similar therapy
Exclusion
- Previously treated with deferiprone and had severe adverse reactions necessitating discontinuation
- Receiving other investigational drugs
- Receiving other drugs known to cause neutropenia
- Unexplained occurrences of neutropenia in past two years
- Pregnant or breastfeeding; or want to become pregnant.
- Sexually active but unwilling to use reliable birth control
- Other conditions which, in the opinion of the investigator, would make patient unsuitable for enrollment
Key Trial Info
Start Date :
March 1 2006
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00293098
Start Date
March 1 2006
Last Update
February 9 2012
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104