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NCT00984451 · ClinicalTrials.gov registry record
A Pilot Study for Collection of Anti-Influenza A Immune Plasma
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 102
- Enrollment target
NCT00984451: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00984451 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 102 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00984451 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 102 participants
- Enrollment target
Study Summary
Background: * The influenza A virus can cause infections that lead to fever, cough, muscle aches, diarrhea, and headaches, and can even be fatal in some people. Seasonal influenza kills an estimated 36,000 people in the United States each year. In addition, more than 200,000 people are hospitalized for flu-related complications. Influenza A has a substantial health effect on every age group. * Currently, treatments are available for influenza A, but there is concern that the rate of complications or even death from this infection is still high despite treatment, and that over time this virus may become resistant to these treatments. Researchers are interested in developing a possible new treatment that uses antibodies against influenza A virus. Objectives: \- To collect plasma (the liquid component of blood containing antibodies) from people who have high levels of antibodies against the influenza A virus because they either have been previously infected with the virus or have been vaccinated against the infection. Eligibility: * Healthy male volunteers between 18 and 60 years of age who are eligible to donate blood. * Individuals must have previously either recovered from influenza infection or have been vaccinated against the infection, and may be subject to other restrictions on participating in National Institutes of Health research studies. Design: * Volunteers will undergo apheresis, an outpatient procedure in which researchers will collect plasma containing antibodies against the influenza virus by drawing blood into a special machine that separates blood cells from the liquid portion under sterile conditions and then returns the blood cells to the donor. * Volunteers will be screened with blood tests to ensure that they are eligible to participate and donate blood. * Volunteers are asked to undergo at least 3 sessions of apheresis; if willing, they can volunteer to participate in up to 20 sessions. * After plasma is collected, it will be tested to ens
Primary Outcome
Subjects will be scheduled for at least 3, and up to 20, plasma collection procedures.
Interventions
- BIOLOGICAL Plasma collection following infection or vaccination with influenza A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2009-09 |
| Est. Completion | 2018-12 |
What the finished NCT00984451 record still lists
NCT00984451 is an observational study that tracks outcomes without assigning an intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Plasma collection following infection or vaccination with influenza A is the first listed.
NCT00984451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00984451 about?
NCT00984451 is a clinical study titled "A Pilot Study for Collection of Anti-Influenza A Immune Plasma". Background: * The influenza A virus can cause infections that lead to fever, cough, muscle aches, diarrhea, and headaches, and can even be fatal in some people. Seasonal influenza kills an estimated 36,000 people in the United States each year. In addition, more than 200,000 people are hospitalized...
What is the current status of trial NCT00984451?
This trial is currently completed. The enrollment target is 102 participants. The study started on 2009-09. Estimated completion is 2018-12.
What interventions are being tested in trial NCT00984451?
The interventions under investigation include: Plasma collection following infection or vaccination with influenza A (BIOLOGICAL).
Who is sponsoring clinical trial NCT00984451?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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