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InfluenzaPhase 3NCT01224795

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

A Phase 3 study testing Peramivir in people with Influenza, run by BioCryst Pharmaceuticals at 96 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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 more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Influenza
What is being tested?
Peramivir
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
96 sitesUnited States
Study dates
Oct 2010to Nov 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 17Show fewer
  • 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.

Trial locations and contacts

96 sites in 1 country.

96 sites in 1 country

United States96 sites

  • Study site

    Akron, Ohio

  • Study site

    Albuquerque, New Mexico

  • Study site

    Anaheim, California

  • Study site

    Arkansas City, Kansas

  • Study site

    Arlington, Texas

  • Study site

    Arlington, Virginia

  • Study site

    Aurora, Illinois

  • Study site

    Austin, Texas

  • Study site

    Bangor, Maine

  • Study site

    Bardstown, Kentucky

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Beaumont, Texas

  • Study site

    Bend, Oregon

  • Study site

    Birmingham, Alabama

  • Study site

    Bloomingdale, Illinois

  • Study site

    Boise, Idaho

  • Study site

    Boulder, Colorado

  • Study site

    Bozeman, Montana

  • Study site

    Bristol, Tennessee

  • Study site

    Brockton, Massachusetts

  • Study site

    Brooksville, Florida

  • Study site

    Bryan, Texas

  • Study site

    Buena Park, California

  • Study site

    Camillus, New York

  • Study site

    Centennial, Colorado

  • Study site

    Charlottesville, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Chino, California

  • Study site

    Coral Gables, Florida

  • Study site

    Cranston, Rhode Island

  • Study site

    Cumberland, Rhode Island

  • Study site

    Cutler Bay, Florida

  • Study site

    Dallas, Texas

  • Study site

    Dayton, Ohio

  • Study site

    Daytona Beach, Florida

  • Study site

    Dinuba, California

  • Study site

    Dubuque, Iowa

  • Study site

    Easley, South Carolina

  • Study site

    Edgewater, Florida

  • Study site

    Fall River, Massachusetts

  • Study site

    Fargo, North Dakota

  • Study site

    Fort Worth, Texas

  • Study site

    Fremont, Nebraska

  • Study site

    Gainesville, Florida

  • Study site

    Garden Grove, California

  • Study site

    Georgetown, Texas

  • Study site

    Greenville, South Carolina

  • Study site

    Hatfield, Pennsylvania

  • Study site

    Hazard, Kentucky

  • Study site

    Hialeah, Florida

  • Study site

    Hollywood, Maryland

  • Study site

    Hot Springs, Arkansas

  • Study site

    Houston, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Johnston, Rhode Island

  • Study site

    Jonesboro, Arkansas

  • Study site

    Lake Jackson, Texas

  • Study site

    Lenexa, Kansas

  • Study site

    Lincoln, California

  • Study site

    Lincoln, Nebraska

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Medford, Oregon

  • Study site

    Miami, Florida

  • Study site

    Milford, Connecticut

  • Study site

    Mountain Home, Arkansas

  • Study site

    North Richland Hills, Texas

  • Study site

    Oceanside, California

  • Study site

    Omaha, Nebraska

  • Study site

    Owasso, Oklahoma

  • Study site

    Paducah, Kentucky

  • Study site

    Palm Springs, California

  • Study site

    Peoria, Illinois

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Port Hueneme, California

  • Study site

    Raleigh, North Carolina

  • Study site

    Rockville, Maryland

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Scotland, Pennsylvania

  • Study site

    Shreveport, Louisiana

  • Study site

    South Bend, Indiana

  • Study site

    South Jordan, Utah

  • Study site

    South Miami, Florida

  • Study site

    Spring, Texas

  • Study site

    Stockbridge, Georgia

  • Study site

    Tustin, California

  • Study site

    Wadsworth, Ohio

  • Study site

    Washington, Missouri

  • Study site

    West Covina, California

  • Study site

    West Jordan, Utah

  • Study site

    West Palm Beach, Florida

  • Study site

    Wheat Ridge, Colorado

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Phase III, Multicenter, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.

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.

Conditions
Influenza
Being tested
Peramivir, Placebo Comparator
Keywords
uncomplicated influenza
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PeramivirDrug

    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.

  • Placebo ComparatorDrug

    Placebo Peramivir, administered intravenously.

Study groups in NCT01224795
Study groupRoleWhat they receive
PeramivirExperimentalAdults (≥ 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.
Receives: Drug: Peramivir
PlaceboPlacebo comparatorPlacebo Peramivir, administered intravenously.
Receives: Drug: Placebo Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 14 Days

Secondary outcomes (1)

  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.

    Measured: 14 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionNov 2010
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01224795
Sponsor's protocol ID
BCX1812-304
Other IDs
HHS 0100200700032C
Status last verified
Jun 2026
First submitted
19 Oct 2010
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Peramivir in people with Influenza, run by BioCryst Pharmaceuticals at 96 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the efficacy of peramivir administered intravenously compared to placebo on the time to alleviation of clinical symptoms with acute uncomplicated influenza. (time frame: 14 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01224795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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