Status:
COMPLETED
Efficacy Study of the Use of Sequential DFP-DFO Versus DFP
Lead Sponsor:
Azienda Ospedaliera V. Cervello
Conditions:
Beta-Thalassemia
Thalassemia Major
Eligibility:
All Genders
13-60 years
Phase:
PHASE4
Brief Summary
Changes in chelation treatment and transfusion practices, during the past two decades, have dramatically improved the prognosis of thalassemia major patients.Deferiprone (DFP) has been compared with d...
Detailed Description
The trial was designed as a multicentre randomised open-label trial with blinded data management and data analyses, to assess whether either treatment was superior to the other. The trial was performe...
Eligibility Criteria
Inclusion
- Thalassemia major patients with serum ferritin concentration between 800 to 3,000 ng/ml and were over 13 years of age
Exclusion
- Known intolerance to one of the trial treatments
- Platelet count \< 100,000/mm3 or or leukocyte count \< 3,000/mm3
- Severe liver damage indicated by ascites
- Heart failure
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT00733811
Start Date
September 1 2000
End Date
January 1 2008
Last Update
August 13 2008
Active Locations (1)
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1
Ao V. Cervello
Palermo, Italy