Intravenous Gammaglobulin for Sickle Cell Pain Crises

This study is currently recruiting participants.

Verified December 2012 by Albert Einstein College of Medicine of Yeshiva University

Sponsor:

Collaborator:

Food and Drug Administration (FDA)

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: December 21, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 8, 2012

Last Updated Date

December 21, 2012

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01757418 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intravenous Gammaglobulin for Sickle Cell Pain Crises

Official Title ^ICMJE

Phase 1-2 Trial of Gamunex (Intravenous Gammaglobulin) for Sickle Cell Acute Pain

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Sickle Cell Disease
Pain

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Deepa G Manwani, M.D	718-741-2342	dmanwani@montefiore.org
Contact: Karen Ireland	718-741-2401	kireland@montefiore.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01757418

Other Study ID Numbers ^ICMJE

7R01FD003447-03

Has Data Monitoring Committee

Yes

Responsible Party

Deepa Manwani, Albert Einstein College of Medicine of Yeshiva University

Study Sponsor ^ICMJE

Albert Einstein College of Medicine of Yeshiva University

Collaborators ^ICMJE

Food and Drug Administration (FDA)

Investigators ^ICMJE

Principal Investigator:

Deepa G Manwani, M.D

Albert Einstein College of Medicine of Yeshiva University

Information Provided By

Albert Einstein College of Medicine of Yeshiva University

Verification Date

December 2012

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

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