Intravenous Gammaglobulin for Sickle Cell Pain Crises

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine of Yeshiva University
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

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