Therapeutic Effect and Safety of Combined Hydroxyurea With Recombinant Human Erythropoietin.
Status:
Unknown status
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
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.