Overview

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

Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Treatments:
Hydroxyurea
Zileuton