Hydroxyurea in Young Children With Sickle Cell Anemia
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sickle Cell Anemia
Intervention: hydroxyurea (Drug)
Phase: N/A
Status: Completed
Sponsored by: Duke University Official(s) and/or principal investigator(s): Courtney D Thornburg, MD mS, Principal Investigator, Affiliation: Duke University
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.
Clinical Details
Official title: Effects of Hydroxyurea on the Prevention of Chronic Organ Damage in Young Children With Sickle Cell Anemia
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Transcranial doppler ultrasound velocityMagnetic resonance imaging/angiography Glomerular Filtration Rate Quality of Life Neurocognitive outcomes
Secondary outcome: Growth parametersHematological parameters
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
Eligibility
Minimum age: 18 Months.
Maximum age: 5 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of Sickle Cell Anemia (Hb SS or Hb S beta zero-thalassemia)
Locations and Contacts
Duke University Medican Center, Durham, North Carolina 27710, United States
Additional Information
Starting date: April 2002
Last updated: August 22, 2007
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