Hydroxyurea in Young Children With Sickle Cell Anemia

This study has been completed.
Sponsor:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00519701
First received: August 21, 2007
Last updated: August 22, 2007
Last verified: August 2007

August 21, 2007
August 22, 2007
April 2002
Not Provided
  • Transcranial doppler ultrasound velocity [ Time Frame: 2 years ]
  • Magnetic resonance imaging/angiography [ Time Frame: 2 years ]
  • Glomerular Filtration Rate [ Time Frame: 2 years ]
  • Quality of Life [ Time Frame: 2 years ]
  • Neurocognitive outcomes [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00519701 on ClinicalTrials.gov Archive Site
  • Growth parameters [ Time Frame: 2 years ]
  • Hematological parameters [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
Hydroxyurea in Young Children With Sickle Cell Anemia
Effects of Hydroxyurea on the Prevention of Chronic Organ Damage in Young Children With Sickle Cell Anemia

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.

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

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Sickle Cell Anemia
Drug: hydroxyurea
Experimental: 1
hydroxyurea
Intervention: Drug: hydroxyurea
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
February 2007
Not Provided

Inclusion Criteria:

  • Clinical diagnosis of Sickle Cell Anemia (Hb SS or Hb S beta zero-thalassemia)
Both
18 Months to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00519701
3297
No
Not Provided
Duke University
Not Provided
Principal Investigator: Courtney D Thornburg, MD mS Duke University
Duke University
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP