Back to resultsHydroxyurea in Young Children With Sickle Cell Anemia
Primary Purpose
Sickle Cell Anemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hydroxyurea
Sponsored by
About this trial
This is an interventional prevention trial for Sickle Cell Anemia focused on measuring sickle cell anemia, hydroxyurea
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Sickle Cell Anemia (Hb SS or Hb S beta zero-thalassemia)
Sites / Locations
- Duke University Medican Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
hydroxyurea
Outcomes
Primary Outcome Measures
Transcranial doppler ultrasound velocity
Magnetic resonance imaging/angiography
Glomerular Filtration Rate
Quality of Life
Neurocognitive outcomes
Secondary Outcome Measures
Growth parameters
Hematological parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00519701
Brief Title
Hydroxyurea in Young Children With Sickle Cell Anemia
Official Title
Effects of Hydroxyurea on the Prevention of Chronic Organ Damage in Young Children With Sickle Cell Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Anemia
Keywords
sickle cell anemia, hydroxyurea
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
hydroxyurea
Intervention Type
Drug
Intervention Name(s)
hydroxyurea
Primary Outcome Measure Information:
Title
Transcranial doppler ultrasound velocity
Time Frame
2 years
Title
Magnetic resonance imaging/angiography
Time Frame
2 years
Title
Glomerular Filtration Rate
Time Frame
2 years
Title
Quality of Life
Time Frame
2 years
Title
Neurocognitive outcomes
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Growth parameters
Time Frame
2 years
Title
Hematological parameters
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Sickle Cell Anemia (Hb SS or Hb S beta zero-thalassemia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney D Thornburg, MD mS
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medican Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hydroxyurea in Young Children With Sickle Cell Anemia
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