A Randomized Prospective Comparative Study of Efficacy and Safety of Continued Iron Chelation Therapy In Poly-transfused Thalassemia Patients With Low Serum Ferritin (< 500 ng/ml)
Sponsor study identifier
interventional
50
1 country
1
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
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Study Completion
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
safety and efficacy of different iron chelation therapy in transfusion dependent beta-thalaasemia patients with low serum ferritin and continued regular transfusion regimen.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
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November 22, 2013
Actual (reported)November 27, 2013
Actual (reported)November 2014
Date type not reportedThis date has not been verified as actual or estimated.
November 2015
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November 2015
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downward-trend of SF(serum ferritin) over previous 6 months after reduction of chelation dose with continuation of regular transfusion regimen.
non inferiority of discounting chelation compared with continuing chelation in thalassemia patients with low serum ferritin and/or showing a downward-trend of SF(serum ferritin) over previous 6 months after reduction of chelation dose with continuation of regular transfusion regimen.
6 month
safety and occurrence of AEs in both studied groups (with and without chelation) in relation to different chelation therapy.
12 month
Included 25 thalassemia patients with low serum ferritin (\< 500) or downward ferritin trend inspite of reduction of chelation dose over the last 6 months. They will continue their chelation therapy.
Included 25 thalassemia patients with low serum ferritin (\< 500) or downward ferritin trend inspite of reduction of chelation dose over the last 6 months. They will be subjected to discontinuation of their chelation therapy.
Deferiprone (75-100 mg/kg/d) and deferoxamine (20-60 mg/kg/d) aimed at achieving "normal" body iron stores in poly-transfued arm1. Arm 2 will only recieve blood transfusion with no chelation
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Pediatric Hematology clinic, Ain Shams University
Cairo, Egypt
Mohsen S. Elalfy, professour
Ain Shams University
First Submitted
November 22, 2013
First Posted
November 27, 2013
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 14, 2015
Record last verified: 2015-01
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