Phase 1-2 Trial of Gamunex (Intravenous Gammaglobulin) for Sickle Cell Acute Pain

About the study

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)

Study point of contact

Karen Ireland
718-741-2401
kireland@montefiore.org
Deepa G Manwani, M.D
718-741-2342
dmanwani@montefiore.org

Locations

1 United States site

Age

12 to 65 Years

Phase

Phase 1/Phase 2

Study type

Interventional

Gender

All

Interventions

Drug

Other

Compensation

Unknown

participation requirements

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

participation restrictions

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

Locations

  • Bronx, New York, United States, Montefiore Medical Center, 10467 [Recruiting]
Last updated 2021-06-09