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NCT02008578 · ClinicalTrials.gov registry record · Phase 1
Anti-Influenza Hyperimmune Intravenous Immunoglobulin Pilot Study (INSIGHT 005: Flu-IVIG Pilot)
A Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 11
- Study locations
NCT02008578: Completed Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02008578 is a Phase 1 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 31 participants, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02008578, a Phase 1 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 11
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Intravenous hyperimmune immunoglobulin (Flu-IVIG)
Study Locations (11)
Ohio
- Ohio State University Wexner Medical Center - Columbus
- Miami Valley Hospital - Dayton
California
- University of California at San Diego - San Diego
Colorado
- Denver Public Health - Denver
District of Columbia
- George Washington University - Washington D.C.
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Michigan
- Henry Ford Hospital - Detroit
Minnesota
- Mayo Clinic - Rochester
New Jersey
- Cooper University Hospital - Camden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT02008578 record still lists
NCT02008578 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02008578 lists 11 locations in 10 states (Ohio, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT02008578 about?
NCT02008578 is a clinical study titled "Anti-Influenza Hyperimmune Intravenous Immunoglobulin Pilot Study (INSIGHT 005: Flu-IVIG Pilot)". 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...
What is the current status of trial NCT02008578?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2013-12. Estimated completion is 2014-06.
What conditions does trial NCT02008578 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT02008578?
The interventions under investigation include: Placebo (BIOLOGICAL), Intravenous hyperimmune immunoglobulin (Flu-IVIG) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02008578?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02008578 being conducted?
This trial has 11 study locations across California, Colorado, District of Columbia, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02008578's enrollment target sits among peer trials
31 138th of 156 higher than 17 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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