Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza

February 24, 2021 updated by: BioCryst Pharmaceuticals

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza.

The purpose of this study is to determine the safety and effectivess of a single intramuscular injection of peramivir for the treatment of subjects with acute, uncomplicated influenza.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Millbrook, Alabama, United States, 36054
        • Physical Express
      • Tuscaloosa, Alabama, United States, 35404
        • Alabama Family Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • HOPE Research Institute
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Clopton Clinic
      • Jonesboro, Arkansas, United States, 72401
        • Research Solutions, LLC
      • Mountain Home, Arkansas, United States, 72653
        • Kevin Adkins, MD
    • California
      • Anaheim, California, United States, 92805
        • NuLife Clinical Research, Inc.
      • Beverly Hills, California, United States, 90211
        • Impact Clinical Trials
      • Buena Park, California, United States, 90620
        • Associated Pharmaceutical Research Center, Inc.
      • Fair Oaks, California, United States, 95628
        • Med Investigations Incorporated
      • Fresno, California, United States, 93703
        • Universal Biopharma Research Institute Inc.
      • Fresno, California, United States, 93726
        • Research Center of Fresno, Inc
      • Garden Grove, California, United States, 92843
        • Harmony Clinical, Inc.
      • Long Beach, California, United States, 90806
        • Allergy, Asthma, and Respiratory Care Medical Center
      • Los Angeles, California, United States, 90017
        • National Institute of Clinical Research
      • Paramount, California, United States, 90723
        • Center for Clinical Trials, LLC
      • San Diego, California, United States, 92120
        • San Diego Sports Medicine and Family Health Center
      • San Luis Obispo, California, United States, 93405
        • Coastal Medical Research Group, Inc.
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Alpine Clinical Research Center
      • Colorado Springs, Colorado, United States, 80904
        • Clinicos, LLC
      • Longmont, Colorado, United States, 80501
        • Longmont Clinic, P.C.
    • Florida
      • Gainesville, Florida, United States, 32605
        • Florida Research Network, LLC
      • Hialeah, Florida, United States, 33012
        • AGA Clinical Trials
      • Hialeah, Florida, United States, 33013
        • Eastern Research
      • Holly Hill, Florida, United States, 32117
        • Century Clinical Research Inc
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Jacksonville, Florida, United States, 32205
        • Jacksonville Center for Clinical Research
      • Jacksonville, Florida, United States, 32257
        • Office of Roger J. Miller, Jr., MD
      • Lake Worth, Florida, United States, 33463
        • MD Now Medical Center
      • Largo, Florida, United States, 33773
        • DMI Healthcare Group
      • Miami, Florida, United States, 33143
        • Well Pharma Medical Research, Corp.
      • Orlando, Florida, United States, 32806
        • Compass Research LLC
      • Pembroke Pines, Florida, United States, 33028
        • Pines Research, LLC
      • Saint Cloud, Florida, United States, 34769
        • Wilker/Powers Center for Clinical Studies
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Georgia
      • Sandersville, Georgia, United States, 31082
        • Sandersville Family Practice Center
    • Illinois
      • Quincy, Illinois, United States, 62301
        • Quincy Medical Group
    • Indiana
      • Indianapolis, Indiana, United States, 46268
        • Investigators Research Group, Llc
      • Newburgh, Indiana, United States, 47630
        • Welborn Clinic Gateway
    • Iowa
      • Dubuque, Iowa, United States, 52001
        • Medical Associates Clinic PC
    • Kansas
      • Shawnee Mission, Kansas, United States, 66216
        • Heart of America Research Institute
      • Topeka, Kansas, United States, 66608
        • American Medical Exams, P.A.
      • Wichita, Kansas, United States, 67212
        • Heartland Research Associates, LLC
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Kentucky Lung Clinic
      • Whitley City, Kentucky, United States, 42653-0099
        • Winchester, Patton, Burgess, PSC
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Gulf Coast Research, LLC
      • Lafayette, Louisiana, United States, 70503
        • Gulf Coast Research LLC
      • Shreveport, Louisiana, United States, 71104
        • Byron Jackson
    • Michigan
      • Benzonia, Michigan, United States, 49616
        • Professional Clinical Research-Benzonia
      • Cadillac, Michigan, United States, 49601
        • Professional Clinical Research, Inc.
      • Interlochen, Michigan, United States, 49643
        • Professional Clinical Research-Interlochen
      • Saint Clair Shores, Michigan, United States, 48081
        • KMED Research
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Olive Branch Family Medical Center
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest
    • Montana
      • Bozeman, Montana, United States, 59715
        • Clinical Research Department
      • Butte, Montana, United States, 59701
        • Mercury Street Medical Group, PLLC
    • Nebraska
      • Fremont, Nebraska, United States, 68025
        • Prarie Fields Family Medicine, P.C
    • New Jersey
      • Hamilton, New Jersey, United States, 08690
        • Quick Care Medical
    • New York
      • Elmira, New York, United States, 14901
        • Health Sciences Research Center at Asthma & Allergy Associates P.C.
      • Ithaca, New York, United States, 14850
        • Health Sciences Research Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27605
        • American Institute of Healthcare & Fitness
    • Ohio
      • Canfield, Ohio, United States, 44406
        • Community Medical Partners
      • Columbus, Ohio, United States, 43207
        • Parsons Avenue Medical Clinic
      • Lyndhurst, Ohio, United States, 44124
        • Ohio Clinical Research LLC
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Physician Care PM
      • Owasso, Oklahoma, United States, 74055
        • Urgent Care of Green County
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Integrated Medical Research PC
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Primary Physicians Research Inc.
      • Warminster, Pennsylvania, United States, 18974
        • Warminster Medical Associates, PC
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • New England Center for Clinical Research, Inc.
      • Johnston, Rhode Island, United States, 02919
        • Clinical Partners, LLC
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Paris View Family Practice
      • Greenville, South Carolina, United States, 29615
        • Andras Koser
      • Simpsonville, South Carolina, United States, 29681
        • Hillcrest Clinical Research, LLC
      • Spartanburg, South Carolina, United States, 29303
        • S. Carolina Pharmaceutical Research
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group, PC
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group, P.C.
    • Texas
      • Beaumont, Texas, United States, 77701
        • DiscoveResearch Inc.
      • Bryan, Texas, United States, 77802
        • DiscoveResearch, Inc.
      • Corpus Christi, Texas, United States, 78411
        • Intrinsic Research Data, Inc.
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Dallas, Texas, United States, 75230
        • Allergy/Immunology Research Center of North Texas
      • Houston, Texas, United States, 77055
        • West Houston Clinical Research Service
      • Houston, Texas, United States, 77070
        • Dynamed Clinical Research, L.P.
      • San Antonio, Texas, United States, 78213
        • Gsa Research
      • San Antonio, Texas, United States, 78205
        • Sun Research Institute
      • San Antonio, Texas, United States, 78229
        • San Antonio Preventive and Diagnostic Medicine
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Optimum Clinical Research
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research, Inc.
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research Inc
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research Inc. Foothill Family Clinic South
      • Saratoga Springs, Utah, United States, 84045
        • Physicians Research Options, LLC
      • West Jordan, Utah, United States, 84088
        • J. Lewis Research Inc. FirstMed
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Virginia Adult & Pediatric Allergy & Asthma, P.C Department of Clinical Research
      • Weber City, Virginia, United States, 24290
        • Holston Medical Group
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and non-pregnant female subjects age ≥18 years.
  • A positive Influenza A and/or B Rapid Antigen Test (RAT) performed with a commercially available test kit on an adequate anterior nasal specimen, in accordance with the manufacturer's instructions. A negative initial RAT should be repeated within one-hour.
  • Presence of fever at time of screening of ≥38.0 ºC (≥100.4 ºF) taken orally, or ≥38.5 ºC (≥101.2 ºF) taken rectally. A subject self-report of a history of fever or feverishness within the 24 hours prior to screening will also qualify for enrollment in the absence of documented fever at the time of screening.
  • 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 48 hours before presentation for screening.
  • Written informed consent.

Exclusion Criteria:

  • Women who are pregnant or breast-feeding.
  • Presence of clinically significant signs of acute respiratory distress.
  • History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma (See section 15.2).
  • History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class III or IV functional status within the past 12 months.
  • Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia.
  • 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, bronchitis, sinusitis and/or pneumonia, or active bacterial infection at 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 prednisone or equivalent on a daily basis within 30 days of screening.
  • Currently receiving treatment for viral hepatitis B or viral hepatitis C.
  • Presence of known HIV infection with a CD4 count <350 cell/mm3.
  • Current therapy with oral warfarin or other systemic anticoagulant.
  • Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening.
  • Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days.
  • Immunized against influenza with inactivated virus vaccine within the previous 14 days.
  • Receipt of any intramuscular injection within the previous 14 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 participation in this study.
  • Participation in a study of any investigational drug or device within the last 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo intramuscular injection
Drug: Placebo
Single intramuscular injection
Experimental: Peramivir
Single intramuscular injection of 300mg peramivir
Drug: Peramivir
To evaluate the efficacy of peramivir administered intramuscularly compared to placebo on the time to alleviation of clinical symptoms in adult subjects with uncomplicated acute influenza.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Time to Alleviation of Clinical Signs and Symptoms of Influenza
Time Frame: Up to 14 days
The primary efficacy endpoint was the time to alleviation of symptoms of influenza in subjects diagnosed with influenza, defined as the time from injection of study drug to the start of the time period when a subject had Alleviation of Symptoms. A subject had Alleviation of Symptoms if each of the seven symptoms of influenza (cough, sore throat, nasal obstruction, myalgia [aches and pains], headache, feverishness, and fatigue) as self-assessed and recorded in the subject diary were either absent or were present at no more than mild severity level and at this status for at least 21.5 hours (24 hours minus 10%). No statistical testing was performed.
Up to 14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To Evaluate Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Time Frame: Change from baseline assessed on days 3, 5 and 9.
The change in influenza viral titers was defined as the time-weighted change from Baseline in log_10 tissue culture infective dose_50 (TCID50/mL) and was summarized for each treatment group. The differences between the treatment groups were planned to be evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID50/mL were obtained at interval visits after treatment. As the study was terminated prematurely, no statistical testing was performed on these data.
Change from baseline assessed on days 3, 5 and 9.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioCryst Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCX1812 311
  • HHS # O100200700032C (Registry Identifier: U.S. Department of Health & Human Services)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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