Therapeutic Effect and Safety of Combined Hydroxyurea With Recombinant Human Erythropoietin.
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.
Timeline
- Start
- 2012-06
- Primary completion
- 2012-12
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxyurea | Other / unclassified | 15 mg/kg | Oral |
| Subject | Hydroxyurea | Other / unclassified | 35 mg/kg | Oral |
| Subject | epoetin alfa | Protein / enzyme biologic | 250 iu/kg | Subcutaneous |
| Subject | epoetin alfa | Protein / enzyme biologic | 500 iu/kg | Subcutaneous |