Flu drug trial pulled before it even started
NCT ID NCT01224795
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study planned to test a single IV dose of peramivir against placebo in teens and adults with uncomplicated flu. The goal was to see if it could shorten flu symptoms like cough, sore throat, and fever. However, the trial was withdrawn before any participants were enrolled, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- peramivir
- What this could lead to
- If it worked, this could provide a faster way to ease flu symptoms for people who need IV treatment.
- What could go wrong
- The trial was withdrawn before enrolling anyone, so we have no results. Even if run, it might not show meaningful benefit over placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Start date
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Oct 2010
- Finished
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Nov 2010
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male and non-pregnant female subjects age ≥12 years. * Test positive for influenza A or B by Rapid Antigen Test (RAT) performed with a commercially available test on an adequate anterior nasal specimen in accordance with the manufacturer's instructions. * Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of at least moderate severity. * Presence of at least one constitutional symptom (myalgia \[aches and pains\], headache,feverishness, or fatigue) of at least moderate severity. * Onset of symptoms no more than 36 hours before presentation for screening. * Written informed consent/assent. Exclusion Criteria: * Women who are pregnant or breast-feeding. * Employees of the study site, or immediate family members of study site employees. * Presence of clinically significant signs of acute respiratory distress. * History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma. * History of heart failure or angina requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class III or IV functional status within the past 12 months. * History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance \<50 mL/min). * Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the investigator's opinion, indicates that such finding(s) could represent complications of influenza. * Current clinical evidence, including clinical signs and/or symptoms consistent with otitis media,bronchitis, sinusitis and/or pneumonia, or active bacterial infection of any body site that requires therapy with oral or systemic antibiotics. * Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy which would include oral or systemic treatment with \> 10 mg ic treatment with \> 10 mg prednisone or equivalent on a daily basis within 30 days of screening. * Presence of known HIV infection with a CD4 count \<350 cell/mm3. * Receipt of any dose of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening. * Immunization against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days. * History of alcohol abuse or drug addiction within 1 year prior to admission in the study. * Participation in a previous study of intramuscular or intravenous peramivir, or previous exposure to peramivir. * Participation in a study of any investigational drug or device within the last 30 days. * Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study. * Presence of any pre-existing illness that in the opinion of the investigator would make the subject unable to comply with the protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Study site
Birmingham, Alabama, United States
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Study site
Hot Springs, Arkansas, United States
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Study site
Jonesboro, Arkansas, United States
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Study site
Little Rock, Arkansas, United States
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Mountain Home, Arkansas, United States
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Anaheim, California, United States
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Study site
Buena Park, California, United States
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Chino, California, United States
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Dinuba, California, United States
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Garden Grove, California, United States
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Lincoln, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Palm Springs, California, United States
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Port Hueneme, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Tustin, California, United States
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Study site
West Covina, California, United States
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Study site
Boulder, Colorado, United States
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Centennial, Colorado, United States
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Wheat Ridge, Colorado, United States
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Milford, Connecticut, United States
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Study site
Brooksville, Florida, United States
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Study site
Coral Gables, Florida, United States
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Study site
Cutler Bay, Florida, United States
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Study site
Daytona Beach, Florida, United States
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Study site
Edgewater, Florida, United States
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Study site
Gainesville, Florida, United States
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Study site
Hialeah, Florida, United States
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Study site
Jacksonville, Florida, United States
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Study site
Miami, Florida, United States
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South Miami, Florida, United States
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Study site
West Palm Beach, Florida, United States
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Study site
Stockbridge, Georgia, United States
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Study site
Boise, Idaho, United States
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Study site
Aurora, Illinois, United States
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Study site
Bloomingdale, Illinois, United States
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Study site
Chicago, Illinois, United States
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Study site
Peoria, Illinois, United States
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Study site
South Bend, Indiana, United States
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Dubuque, Iowa, United States
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Arkansas City, Kansas, United States
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Study site
Lenexa, Kansas, United States
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Bardstown, Kentucky, United States
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Hazard, Kentucky, United States
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Paducah, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Study site
Shreveport, Louisiana, United States
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Bangor, Maine, United States
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Study site
Hollywood, Maryland, United States
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Study site
Rockville, Maryland, United States
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Brockton, Massachusetts, United States
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Study site
Fall River, Massachusetts, United States
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Washington, Missouri, United States
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Study site
Bozeman, Montana, United States
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Study site
Fremont, Nebraska, United States
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Study site
Lincoln, Nebraska, United States
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Study site
Omaha, Nebraska, United States
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Study site
Albuquerque, New Mexico, United States
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Study site
Camillus, New York, United States
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Study site
Raleigh, North Carolina, United States
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Study site
Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Study site
Akron, Ohio, United States
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Study site
Dayton, Ohio, United States
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Study site
Wadsworth, Ohio, United States
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Study site
Owasso, Oklahoma, United States
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Study site
Bend, Oregon, United States
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Study site
Medford, Oregon, United States
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Study site
Hatfield, Pennsylvania, United States
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Study site
Philadelphia, Pennsylvania, United States
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Study site
Scotland, Pennsylvania, United States
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Study site
Cranston, Rhode Island, United States
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Study site
Cumberland, Rhode Island, United States
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Study site
Johnston, Rhode Island, United States
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Study site
Easley, South Carolina, United States
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Study site
Greenville, South Carolina, United States
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Study site
Bristol, Tennessee, United States
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Study site
Arlington, Texas, United States
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Study site
Austin, Texas, United States
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Study site
Beaumont, Texas, United States
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Study site
Bryan, Texas, United States
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Study site
Dallas, Texas, United States
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Study site
Fort Worth, Texas, United States
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Study site
Georgetown, Texas, United States
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Study site
Houston, Texas, United States
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Study site
Lake Jackson, Texas, United States
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Study site
North Richland Hills, Texas, United States
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Study site
San Antonio, Texas, United States
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Study site
Spring, Texas, United States
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Study site
Salt Lake City, Utah, United States
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Study site
South Jordan, Utah, United States
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Study site
West Jordan, Utah, United States
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Study site
Arlington, Virginia, United States
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Study site
Charlottesville, Virginia, United States
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Other studies related to the condition(s) this trial covers.
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- Can a new pill shorten the flu?