Hydroxyurea in Young Children With Sickle Cell Anemia
- Registration Number
- NCT00519701
- Lead Sponsor
- Duke University
- Brief Summary
The purpose of this study is to asses prospectively the safety and efficacy of hydroxyurea therapy in children with Sickle cell Anemia between ages 18 months and 5 years, with special emphasis on the ability of hydroxyurea to prevent or reverse chronic organ damage.
- Detailed Description
Previous studies have shown that hydroxyurea therapy in adults and older children with SCA improves laboratory parameters and ameliorates the clinical severity of disease. Little is known, however, about the effects of hydroxyurea on the chronic organ damage that occurs in patients with SCA and leads to significant morbidity and mortality in young adults. The objectives of this study are to assess the safety and efficacy of HU in young children with SCA and to determine whether HU preserves renal function, reduces transcranial doppler ultrasound (TCD) values, and prevents development of brain ischemia as evidenced by MRI/MRA imaging. In addition, we will evaluate the effects of hydroxyurea on quality of life
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Clinical diagnosis of Sickle Cell Anemia (Hb SS or Hb S beta zero-thalassemia)
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 hydroxyurea hydroxyurea
- Primary Outcome Measures
Name Time Method Transcranial doppler ultrasound velocity 2 years Magnetic resonance imaging/angiography 2 years Glomerular Filtration Rate 2 years Quality of Life 2 years Neurocognitive outcomes 2 years
- Secondary Outcome Measures
Name Time Method Growth parameters 2 years Hematological parameters 2 years
Trial Locations
- Locations (1)
Duke University Medican Center
🇺🇸Durham, North Carolina, United States