Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519701
Status:
COMPLETED
Last Update Posted:
2007-08-23
First Post:
2007-08-21
Brief Title:
Hydroxyurea in Young Children With Sickle Cell Anemia
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Effects of Hydroxyurea on the Prevention of Chronic Organ Damage in Young Children With Sickle Cell Anemia
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 MRIMRA imaging In addition we will evaluate the effects of hydroxyurea on quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None