| Karen Ireland | |
| 718-741-2401 | |
| [email protected] |
| Deepa G Manwani, M.D | |
| 718-741-2342 | |
| [email protected] |
1 United States site
12 to 65 Years
Phase 1/Phase 2
Interventional
All
Drug
Other
Unknown
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)
– Documented diagnosis of sickle cell disease (SS or S-β thalassemia genotype)
– Age 12-65 years for Phase 1, 8-13.99 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