Status:
COMPLETED
Trial of Zileuton CR in Children and Adults With Sickle Cell Disease
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to test the safety of Zileuton and see what effects (good and bad) it has on you, other children and adults with Sickle Cell Disease (SCD). The investigators also...
Detailed Description
Inflammation is now recognized as central to the pathophysiology of sickle cell disease (SCD), and is manifest as leukocytosis, elevated levels of inflammatory cytokines, and activation of monocytes, ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of SCD (HbSS,HbSC,HBS Beta thalassemia, or HBS 0 thalassemia)
- Absence of an acute sickle event or ACS in the last 4 wks
- Not on hydroxyurea
- Ability to swallow pills
- Ability to comply with pulmonary function testing
Exclusion
- History of active hepatitis
- HIV positivity
- Pregnant or nursing
- Unable to comply with contraceptive measures
- On an investigational drug within 4 weeks
- On hydroxyurea, leukotriene antagonists (e.g., Singulair) or steroids, theophylline, coumadin, terfenadine or beta-2 blockers that affect the airway: carteolol, carvedilol, labetalol, nadolol, penbutolol, pindolol, sotalol and timolol, or on propranolol for the last four weeks
- On chronic transfusion therapy
- A serious, concurrent illness that would limit ability to complete or comply with the study requirements
- Males who drink alcoholic beverages \>5-6 drinks/day or females who drink alcoholic beverages \>3-4 drinks/day
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01136941
Start Date
September 1 2010
End Date
April 1 2013
Last Update
June 18 2014
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229