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Hydroxyurea in Young Children With Sickle Cell Anemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519701
First Posted: August 23, 2007
Last Update Posted: August 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Duke University
August 21, 2007
August 23, 2007
August 23, 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
No Changes Posted
  • 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
Intervention Model: Single Group Assignment
Masking: None (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)
Sexes Eligible for Study: All
18 Months to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00519701
3297
No
Not Provided
Not Provided
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