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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 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


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


Minimum age: 12 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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


- 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: August 23, 2015

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