Intravenous Gammaglobulin for Sickle Cell Pain Crises

  • End date
    Jul 20, 2024
  • participants needed
  • sponsor
    Albert Einstein College of Medicine
Updated on 4 October 2022
acute pain


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)


Patients will be randomized to a single dose of IVIG versus normal saline placebo during an uncomplicated pain crisis. Length of VOC and other secondary endpoints will be monitored.

Condition Sickle Cell Disease, Pain
Treatment Normal saline, Immune Globulin Intravenous
Clinical Study IdentifierNCT01757418
SponsorAlbert Einstein College of Medicine
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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