Hydroxyurea in Young Children With Sickle Cell Anemia

Sickle Cell Anemia Clinical Trial

Official title:

Effects of Hydroxyurea on the Prevention of Chronic Organ Damage in Young Children With Sickle Cell Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519701
• Other study ID #: 3297
• Status: Completed
• Phase: N/A
• First received: August 21, 2007
• Last updated: August 22, 2007
• Start date: April 2002
• Est. completion date: February 2007

Study information

• Verified date: August 2007
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 5 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Sickle Cell Anemia (Hb SS or Hb S beta zero-thalassemia)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Sickle Cell Anemia

Intervention

Drug:
• hydroxyurea

Locations

Country	Name	City	State
United States	Duke University Medican Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcranial doppler ultrasound velocity		2 years
Primary	Magnetic resonance imaging/angiography		2 years
Primary	Glomerular Filtration Rate		2 years
Primary	Quality of Life		2 years
Primary	Neurocognitive outcomes		2 years
Secondary	Growth parameters		2 years
Secondary	Hematological parameters		2 years