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Intravenous Gammaglobulin for Sickle Cell Pain Crises

Information source: Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov processed this data on November 27, 2014
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

Page last updated: November 27, 2014

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