Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza

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: Terminated
• Conditions: Influenza
• Intervention / Treatment: Drug: Placebo; Drug: Peramivir

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
The Time to Alleviation of Clinical Signs and Symptoms of Influenza	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

Outcome Measure	Measure Description	Time Frame
To Evaluate Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.	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

• Sponsor: BioCryst Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: January 25, 2008
• First Submitted That Met QC Criteria: February 7, 2008
• First Posted (Estimate): February 8, 2008

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Influenza; Subjects with uncomplicated acute influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Peramivir
• Other Study ID Numbers: BCX1812 311; HHS # O100200700032C (Registry Identifier: U.S. Department of Health & Human Services)