ClinicalTrials.gg
WithdrawnNCT01224795Updated Jun 10, 2026

A Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.

A Phase 3 interventional study of Peramivir and Placebo Comparator in Influenza, sponsored by BioCryst Pharmaceuticals. Withdrawn at 96 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by BioCryst Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

This is a study to evaluate the efficacy and safety of a single dose of intravenous peramivir versus placebo in adolescents and adults with acute uncomplicated influenza.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single dose of intravenous peramivir versus placebo in adolescents and adults with acute,uncomplicated influenza.

02

Conditions studied

  • Influenza

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Keywords

  • uncomplicated influenza
03

In context

Influenza, Human

2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.

Browse Influenza, Human studies →

Lead sponsor

BioCryst Pharmaceuticals is the lead sponsor of 54 studies on the registry; 1 is open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 /assent.

Exclusion criteria

Exclusion Criteria:

  • Women who are pregnant or breast-feeding.
  • Employees of the study site, or immediate family members of study site employees.
  • Presence of signs of acute respiratory distress.
  • History of severe (COPD) or severe persistent asthma.
  • History of heart failure or angina requiring daily pharmacotherapy with symptoms consistent with 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 \<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 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 infection with a \<350 cell/mm3.
  • Receipt of any dose of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening.
  • Immunization against influenza with (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 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.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Peramivir

    Adults (≥ 18 years): Peramivir 600 mg, administered intravenously. Adolescents (12 to \< 18 years): Peramivir 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously.

    Drug: Peramivir

  • Placebo comparator
    Placebo

    Placebo Peramivir, administered intravenously.

    Drug: Placebo Comparator

Interventions

  • Adults (≥ 18 years): Peramivir 600 mg, administered intravenously. Adolescents (12 to \< 18 years): Peramivir 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously.

  • DrugPlacebo Comparator

    Placebo Peramivir, administered intravenously.

06

What researchers measure

Primary outcomes

  1. To evaluate the efficacy of peramivir administered intravenously compared to placebo on the time to alleviation of clinical symptoms with acute uncomplicated influenza.

    Time to alleviation of clinical symptoms in adolescents and adults with uncomplicated acute influenza measured from patient reported study diaries.

    Time frame: 14 Days

Secondary outcomes

  1. To evaluate the safety and tolerability of peramivir administered intravenously

    To evaluate time to resolution of fever in response to treatment. To evaluate changes in influenza virus titer in nasal and pharyngeal samples (viral shedding) in response to treatment. To evaluate secondary clinical outcomes and changes in virus susceptibility to neuraminidase inhibitors in response to treatment.

    Time frame: 14 Days

07

Study locations

96 sites
  • Birmingham, Alabama, United States
  • Hot Springs, Arkansas, United States
  • Jonesboro, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Mountain Home, Arkansas, United States
  • Anaheim, California, United States
  • Buena Park, California, United States
  • Chino, California, United States
  • Dinuba, California, United States
  • Garden Grove, California, United States
  • Lincoln, California, United States
  • Los Angeles, California, United States
  • Oceanside, California, United States
  • Palm Springs, California, United States
  • Port Hueneme, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • Tustin, California, United States
  • West Covina, California, United States
  • Boulder, Colorado, United States
  • Centennial, Colorado, United States
  • Wheat Ridge, Colorado, United States
  • Milford, Connecticut, United States
  • Brooksville, Florida, United States
  • Coral Gables, Florida, United States
  • Cutler Bay, Florida, United States
  • Daytona Beach, Florida, United States
  • Edgewater, Florida, United States
  • Gainesville, Florida, United States
  • Hialeah, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • South Miami, Florida, United States
  • West Palm Beach, Florida, United States
  • Stockbridge, Georgia, United States
  • Boise, Idaho, United States
  • Aurora, Illinois, United States
  • Bloomingdale, Illinois, United States
  • Chicago, Illinois, United States
  • Peoria, Illinois, United States
  • South Bend, Indiana, United States
  • Dubuque, Iowa, United States
  • Arkansas City, Kansas, United States
  • Lenexa, Kansas, United States
  • Bardstown, Kentucky, United States
  • Hazard, Kentucky, United States
  • Paducah, Kentucky, United States
  • Baton Rouge, Louisiana, United States
  • Shreveport, Louisiana, United States
  • Bangor, Maine, United States
  • Hollywood, Maryland, United States
  • Rockville, Maryland, United States
  • Brockton, Massachusetts, United States
  • Fall River, Massachusetts, United States
  • Washington, Missouri, United States
  • Bozeman, Montana, United States
  • Fremont, Nebraska, United States
  • Lincoln, Nebraska, United States
  • Omaha, Nebraska, United States
  • Albuquerque, New Mexico, United States
  • Camillus, New York, United States
  • Raleigh, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Fargo, North Dakota, United States
  • Akron, Ohio, United States
  • Dayton, Ohio, United States
  • Wadsworth, Ohio, United States
  • Owasso, Oklahoma, United States
  • Bend, Oregon, United States
  • Medford, Oregon, United States
  • Hatfield, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Scotland, Pennsylvania, United States
  • Cranston, Rhode Island, United States
  • Cumberland, Rhode Island, United States
  • Johnston, Rhode Island, United States
  • Easley, South Carolina, United States
  • Greenville, South Carolina, United States
  • Bristol, Tennessee, United States
  • Arlington, Texas, United States
  • Austin, Texas, United States
  • Beaumont, Texas, United States
  • Bryan, Texas, United States
  • Dallas, Texas, United States
  • Fort Worth, Texas, United States
  • Georgetown, Texas, United States
  • Houston, Texas, United States
  • Lake Jackson, Texas, United States
  • North Richland Hills, Texas, United States
  • San Antonio, Texas, United States
  • Spring, Texas, United States
  • Salt Lake City, Utah, United States
  • South Jordan, Utah, United States
  • West Jordan, Utah, United States
  • Arlington, Virginia, United States
  • Charlottesville, Virginia, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2010, a primary completion of Nov 2010 and a completion of Nov 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2010
First posted
Oct 20, 2010
Start
Oct 2010
Primary completionActual
Nov 2010
CompletionActual
Nov 2010
Results delay requested
Dec 14, 2011
Last update
Jun 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01224795
Collaborators
Department of Health and Human Services
Responsible party
Sponsor
First posted
Oct 20, 2010
Start date
Oct 2010
Primary completion
Nov 2010
Completion
Nov 2010
Last update
Jun 10, 2026

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Peramivir

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