Intravenous Gammaglobulin for Sickle Cell Pain Crises

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Information provided by (Responsible Party):
Deepa Manwani, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01757418
First received: November 8, 2012
Last updated: June 20, 2014
Last verified: June 2014

November 8, 2012
June 20, 2014
November 2008
July 2014   (final data collection date for primary outcome measure)
Duration of pain crisis [ Time Frame: Number of days from study drug infusion to end of crisis, average 4 days and maximum 30days ] [ Designated as safety issue: No ]
End of crisis defined as either 1) Pain score consistently ≤ 5 (on the visual analog or Wong-Baker FACES scale) AND off of IV opioids or 2) Hospital discharge
Same as current
Complete list of historical versions of study NCT01757418 on ClinicalTrials.gov Archive Site
Total opioid use in equivalent of mg of IV morphine [ Time Frame: From study drug infusion to end of crisis, average 4 days and maximum 30days ] [ Designated as safety issue: No ]
End of crisis defined as either: 1)Pain score consistently ≤ 5 (on the visual analog or Wong-Baker FACES scale AND off of IV opioids or 2) Hospital discharge
Same as current
Not Provided
Not Provided
 
Intravenous Gammaglobulin for Sickle Cell Pain Crises
Phase 1-2 Trial of Gamunex (Intravenous Gammaglobulin) for Sickle Cell Acute Pain

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)

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Sickle Cell Disease
  • Pain
  • Drug: Immune Globulin Intravenous
    A single dose of intravenous immune globulin or saline placebo administered within 18 hours of hospital presentation. The current maximum dose planned is 800 mg/kg.
    Other Name: GAMUNEX (Talecris Biotherapeutics)
  • Drug: Normal saline
  • Experimental: Immune Globulin Intravenous
    IVIG used in the trial is the GAMUNEX brand, at doses up through 800 mg/kg.
    Intervention: Drug: Immune Globulin Intravenous
  • Placebo Comparator: Normal saline
    An equivalent volume (weight-based)of normal saline
    Intervention: Drug: Normal saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
12 Years to 65 Years
No
Contact: Deepa G Manwani, M.D 718-741-2342 dmanwani@montefiore.org
Contact: Karen Ireland 718-741-2401 kireland@montefiore.org
United States
 
NCT01757418
7R01FD003447-03, FD-R-003447-01-A1
Yes
Deepa Manwani, Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
Not Provided
Principal Investigator: Deepa G Manwani, M.D Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP