Anti-Influenza Hyperimmune Intravenous Immunoglobulin Pilot Study (INSIGHT 005: Flu-IVIG Pilot)
Completed · Phase 1 · Has a placebo group
Conditions studied: Influenza
In brief
The purpose of this randomized, double-blind, placebo-controlled trial of intravenous hyperimmune immunoglobulin (Flu-IVIG) in individuals with influenza A or B is to determine the pharmacokinetic (PK) profile of Flu-IVIG and assess whether antibody levels observed following Flu-IVIG transfusion are similar to those predicted. This pilot study will inform a larger study that will be powered to compare Flu-IVIG with placebo for efficacy.
Key facts
- Study ID
- NCT02008578
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 31
- Starts
- 2013-12-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2016-08-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- If hospitalized, admitted for reasons other than influenza or complications of influenza
- Women who are pregnant or breast-feeding
- Strong clinical evidence (in the judgment of the site investigator) that the etiology of illness is primarily bacterial in origin.
- Prior treatment with any investigational drug therapy within 30 days prior to screening
- History of allergic reaction to blood or plasma products (as judged by the investigator)
- Known IgA deficiency
- A pre-existing condition or use of medication that, in the opinion of the investigator, may place the individual at a substantially increased risk of thrombosis (e.g., cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy)
- Serum creatinine greater than or equal to 1.5 x ULN or known active kidney disease that may affect drug pharmacokinetics (e.g., nephrotic syndrome)
- Presence of any pre-existing illness that, in the opinion of the investigator, would place the individual at an unreasonably increased risk through participation in this study
- Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
- Medical conditions for which receipt of 500mL volume may be dangerous to the patient (e.g., decompensated congestive heart failure)
- Suspicion that infection is due to an influenza strain or subtype other than A(H1N1)pdm09, H3N2, or influenza B (e.g., H5N1, H7N9)
Where it is running
- University of California at San Diego — San Diego, California, United States
- Denver Public Health — Denver, Colorado, United States
- George Washington University — Washington D.C., District of Columbia, United States
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Cooper University Hospital — Camden, New Jersey, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Ohio State University Wexner Medical Center — Columbus, Ohio, United States
- Miami Valley Hospital — Dayton, Ohio, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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