Intravenous Gammaglobulin for Sickle Cell Pain Crises
Information source: Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sickle Cell Disease; Pain
Intervention: Immune Globulin Intravenous (Drug); Normal saline (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Albert Einstein College of Medicine of Yeshiva University Official(s) and/or principal investigator(s): Deepa G Manwani, M.D, Principal Investigator, Affiliation: Albert Einstein College of Medicine of Yeshiva University
Overall contact: Deepa G Manwani, M.D, Phone: 718-741-2342, Email: dmanwani@montefiore.org
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)
Clinical Details
Official title: Phase 1-2 Trial of Gamunex (Intravenous Gammaglobulin) for Sickle Cell Acute Pain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Duration of pain crisis
Secondary outcome: Total opioid use in equivalent of mg of IV morphine
Eligibility
Minimum age: 12 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Documented diagnosis of sickle cell disease (SS or S-β thalassemia genotype)
- Age 12-65 years
- 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%
- 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 and Contacts
Deepa G Manwani, M.D, Phone: 718-741-2342, Email: dmanwani@montefiore.org
Montefiore Medical Center, Bronx, New York 10467, United States; Recruiting Deepa G Manwani, MD, Phone: 718-741-2342, Email: dmanwani@montefiore.org Deepa G Manwani, MD, Principal Investigator
Additional Information
Related publications: Chang J, Shi PA, Chiang EY, Frenette PS. Intravenous immunoglobulins reverse acute vaso-occlusive crises in sickle cell mice through rapid inhibition of neutrophil adhesion. Blood. 2008 Jan 15;111(2):915-23. Epub 2007 Oct 11. Turhan A, Jenab P, Bruhns P, Ravetch JV, Coller BS, Frenette PS. Intravenous immune globulin prevents venular vaso-occlusion in sickle cell mice by inhibiting leukocyte adhesion and the interactions between sickle erythrocytes and adherent leukocytes. Blood. 2004 Mar 15;103(6):2397-400. Epub 2003 Nov 20.
Starting date: November 2008
Last updated: June 20, 2014
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