Anemia, Sickle Cell Clinical Trial
Official title:
Protocol for the Administration of Hydroxyurea During Painful Vaso-occlusive Crisis in Sickle Cell Anemia
This study will investigate the safety, tolerability and potential for the use of up to three daily doses of 30-40 mg/kg HU (daily) upon hospitalization for painful vaso-occlusive crises .
Sickle cell anemia (SCA) is a hereditary hemoglobinopathy; complications of the disease
include, spleen enlargement, acute chest syndrome, pulmonary hypertension, stroke and
cumulative damage to multiple organs, and painful vaso-occlusive crises (VOC). In Brazil,
about 3,500 children are born each year with DF, and the number of individuals with sickle
cell disease (DF) in the country is estimated between 25,000 and 30,000 (ANVISA 2012;
BRAZIL, 2012).
Hydroxyurea (HU, or hydroxycarbamide) is the only drug approved to date by the American FDA
for use in adults with sickle cell disease. The drug modifies the disease process, improving
hematological parameters and the hospitalization time of patients, as well as the frequency
of vaso-occlusive crises.In addition to its proven effects during chronic use, experimental
data indicate that HU has immediate anti-inflammatory effects.
In addition to its proven effects during chronic use, experimental data indicate that HU has
immediate anti-inflammatory effects. This study will investigate the safety, tolerability
and potential for the use of up to three daily doses of 30-40 mg/kg HU (daily) upon
hospitalization for VOC.
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