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

Study point of contact

Karen Ireland
718-741-2401
[email protected]
Deepa G Manwani, M.D
718-741-2342
[email protected]

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

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)

participation requirements

– 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

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]