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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 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.

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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

Influenza

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

FieldValue
Enrollment Target 31 participants
Start Date 2013-12
Est. Completion 2014-06
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT02008578

The ClinicalTrials.gov registry entry for NCT02008578 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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 reports 11 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.