Sponsor study identifier
interventional
40
1 country
1
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The study hypothesis that treatment with Erythropoietin (EPO) combined with Human Erythropoietin (HUO) therapy will result in hematologic improvement in thalassemia intermedia patients. Second is to determine whether any of the following correlate with improved hematologic response: A decrease in hemolysis, as assayed by a decrease in LDH, compared to baseline levels,baseline Erythropoietin levels,baseline hemoglobin levels and baseline reticulocyte counts (or % circulating nucleated erythroblasts/100 WBCs). Goal: The aim is to assess the possibility of steady increase of hemoglobin levels in thalassemia intermedia patients by at least 1g/dl above baseline levels during therapy using Hydroxyurea and Erythropoietin, growth evaluation,quality of life (QoL) and decline transfusion requirements during study period. Also to report and compare adverse events with other published data regarding.
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December 2012
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April 13, 2012
Actual (reported)June 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 20, 2012
Actual (reported)December 2012
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December 2012
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Change in baseline transfusion frequency with increase of pre-transfusion hemoglobin
Decrease in baseline transfusion frequency with increase of pre-transfusion hemoglobin by calculation of transfusion index and mean hemoglobin level
baseline and 6 month hemoglobin level and transfusion frequency
Change in baseline quality of life assessment.
baseline and 6 month QOL questionaire
Hydroxyurea (Myers-Squibb, USA) was administered in dosages ranging from 15 up to 35 mg/kg/day orally over 7 days/week.
* Hydroxyurea (Myers-Squibb, USA) was administered in dosages ranging from 15 up to 35 mg/kg/day orally over 7 days/week. Hydroxyurea toxicity was defined as a white cell count of less than 2500/μL or a platelet count of less than 100,000/μL, in which case the drug was discontinued. White cell count and platelet count were determined on a monthly basis. Side effects such as nausea, vomiting, diarrhea, rashes, and malaise, experienced during the first 6 h after taking the HU will be considered as clinical toxicity. * Erythropiotien therapy (rHuEPO - Epiao) from 250 to 500 IU/kg rHuEPO subcutaneously three times a week.
Hydroxyurea (Myers-Squibb, USA) was administered in dosages ranging from 15 up to 35 mg/kg/day orally over 7 days/week. Erythropiotien therapy (rHuEPO - Epiao) from 250 to 500 IU/kg rHuEPO subcutaneously three times a week.
* Hydroxyurea was administered in dosages ranging from 15 up to 35 mg/kg/day orally over 7 days/week. Hydroxyurea toxicity was defined as a white cell count of less than 2500/μL or a platelet count of less than 100,000/μL, in which case the drug was discontinued.
hematology clinic ,pediatrics hospital, Ain Shams University hospital
Cairo, Egypt
Elalfy MS, Adly AA, Ismail EA, Elhenawy YI, Elghamry IR. Therapeutic superiority and safety of combined hydroxyurea with recombinant human erythropoietin over hydroxyurea in young beta-thalassemia intermedia patients. Eur J Haematol. 2013 Dec;91(6):522-33. doi: 10.1111/ejh.12182. Epub 2013 Oct 5.
Mohsen S Elalfy, professor
Ain Shams University
First Submitted
April 13, 2012
First Posted
June 20, 2012
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Estimated (date passed)"Iron Overload and Endocrinological Diseases"
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Study Completion
December 2012
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Last Updated
June 20, 2012
Record last verified: 2012-06
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