Table 6

NHLBI-sponsored clinical trials that involve hydroxyurea treatment for children and adolescents with sickle cell disease, as of January 2010

Protocolwww.ClinicalTrials.gov NCTDescriptionEnrollmentTreatment
BABY HUG 00006400 Phase 3 Completed Completed 
  Hydroxyurea versus placebo   
  HbSS, age 9-18 mo   
SWiTCH 00122980 Phase 3 Completed Ongoing 
  Hydroxyurea/phlebotomy versus transfusion/chelation   
  HbSS, age 5-19 y with previous stroke and iron overload   
HUSTLE 00305175 Observational longitudinal Recruiting Ongoing 
  Open-label hydroxyurea therapy   
  HbSS, age < 30 y   
CHAMPS 00532883 Phase 3 Terminated Completed 
  Hydroxyurea and magnesium pidolate versus placebo   
  HbSC, all ages   
TWiTCH Pending Phase 3 Not yet opened Not yet opened 
  Hydroxyurea versus transfusion   
  HbSS, age 4-16 y   
Protocolwww.ClinicalTrials.gov NCTDescriptionEnrollmentTreatment
BABY HUG 00006400 Phase 3 Completed Completed 
  Hydroxyurea versus placebo   
  HbSS, age 9-18 mo   
SWiTCH 00122980 Phase 3 Completed Ongoing 
  Hydroxyurea/phlebotomy versus transfusion/chelation   
  HbSS, age 5-19 y with previous stroke and iron overload   
HUSTLE 00305175 Observational longitudinal Recruiting Ongoing 
  Open-label hydroxyurea therapy   
  HbSS, age < 30 y   
CHAMPS 00532883 Phase 3 Terminated Completed 
  Hydroxyurea and magnesium pidolate versus placebo   
  HbSC, all ages   
TWiTCH Pending Phase 3 Not yet opened Not yet opened 
  Hydroxyurea versus transfusion   
  HbSS, age 4-16 y   

NHLBI indicates National Heart, Lung, and Blood Institute.