Trial of Zileuton CR in Children and Adults With Sickle Cell Disease

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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 want to see how Zileuton is handled by your body at different doses.

Zileuton is a drug that is approved by the Food and Drug Administration (FDA) for the treatment of asthma for people age 12 and older. The FDA has not approved Zileuton for the treatment of SCD, so it is being studied as an investigational drug for SCD through an application to the FDA. In asthma patients, Zileuton helps by reducing inflammation. This study will see if Zileuton helps to reduce inflammation associated with SCD.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Hydroxyurea; Zileuton

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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