At a glance
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Assessing Combination Hydroxyurea and Exogenous Erythropoietin in Sickle Cell Disease
In Brief
A Phase 2 clinical trial evaluating Hydroxyurea and Epoetin Alfa-BioSimilar for Anemia, Sickle Cell and Sickle Cell Disease. Completed, enrolled 17 participants across 2 sites in 2 countries.
Detailed Summary
The proposed study is a Phase 1/2 multi-center study evaluating the safety and efficacy of erythropoietin (EPO) in combination with hydroxyurea in the treatment of chronic anemia in patients with sickle cell disease (SCD).
Study Details
Timeline
Interventions
Hydroxyurea is an orally available antimetabolite medication that has been shown to reduce the frequency of painful crises and acute chest syndrome in adults and children with sickle cell disease. Hydroxyurea treats sickle cell disease by a number of different mechanisms, including increasing the expression of fetal hemoglobin (HbF), which reduces sickling of red blood cells.
Epoetin alfa and its biosimilars are first-generation erythropoiesis-stimulating agents (ESAs), which are recombinant versions of erythropoietin (EPO) produced using recombinant DNA technology. Erythropoietin (EPO) is a glycoprotein hormone, naturally produced mainly in the kidneys in response to hypoxia and stimulates red blood cell production (erythropoiesis) in the bone marrow.