The purpose of this study is to determine whether intravenous immune globulin is safe and effective in the acute treatment of pain crises in sickle cell disease.
Funding Source: Food and Drug Administration (FDA), Office of Orphan Products Development (OOPD)
| Deepa G Manwani, M.D | |
| 718-741-2342 | |
| [email protected] |
| Karen Ireland | |
| 718-741-2401 | |
| [email protected] |
31 United States site
12 Years - 65 Years
Phase 1/Phase 2
Interventional
All
Drug
Other
Documented diagnosis of sickle cell disease (SS or S-β thalassemia genotype)
Age 12-65 years for Phase 1, 6-13.99 years for Phase 2
Uncomplicated acute pain episode requiring hospital admission and parenteral narcotics
Increased stroke risk as assessed by transcranial Doppler or magnetic resonance imaging (all subjects undergo testing)
Concomitant acute process, including fever > 38.5° C with clinical suspicion of infection
Increased ALT > 2X ULN
Serum creatinine ≥1.3 mg/dL, >300 mg/dL protein in spot urinalysis, or known condition associated with renal dysfunction
Hb > 10 g/dL and Hct > 30%
Hb< 5 g/dl
Known IgA deficiency or known allergy to gamma globulin
Pregnancy or breastfeeding
Vaccination with a live attenuated virus in the preceding 6 weeks
Documented history of illicit (eg. heroin, cocaine) drug abuse or drug-seeking behavior
Current participation in another investigational drug study
Current treatment with chronic transfusion
Prior thromboses or current estrogen use