Intravenous Gammaglobulin for Sickle Cell Pain Crises

STATUS

Recruiting
End date

Jul 20, 2024
participants needed

94
sponsor

Albert Einstein College of Medicine

Updated on 4 October 2022

See if I qualify

narcotics

acute pain

thalassemia

Summary

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)

Description

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.

Details

Condition	Sickle Cell Disease, Pain
Treatment	Normal saline, Immune Globulin Intravenous
Clinical Study Identifier	NCT01757418
Sponsor	Albert Einstein College of Medicine
Last Modified on	4 October 2022

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Eligibility		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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Intravenous Gammaglobulin for Sickle Cell Pain Crises