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A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza

12. februar 2015 opdateret af: BioCryst Pharmaceuticals
The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

405

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
      • Adelaide, Australien, 5076
        • Athelstone Medical Clinic
      • Brisbane, Australien
        • Trialworks Clinical Research Services
      • Burwood, Australien
        • Dr Doongs Surgery
      • Darlinghurst, Australien
        • Holdsworth House Medical Practice
      • Melbourne, Australien
        • Doctors of Ivanhoe,
      • Nedlands, Australien
        • Lung Institute of Western Australia,
      • Sydney, Australien
        • Pitt Street Merrylands Medical Centre
    • New South Wales
      • Blacktown, New South Wales, Australien, 2148
        • Pacific Medical Centre Blacktown
      • Darlinghurst, New South Wales, Australien, 2010
        • East Sydney Doctors
      • Hurtsville, New South Wales, Australien, 2220
        • Symbion Pathology
      • Umina, New South Wales, Australien, 2257
        • Peninsula Medical Centre
    • Queensland
      • Auchenflower, Queensland, Australien, 4066
        • Rivercity Private Hospital Specialist
      • Caboolture, Queensland, Australien, 4510
        • Caboolture Clinical Research Centre
      • Kpparing, Queensland, Australien, 4021
        • Peninsula Specialist Centre
    • Victoria
      • Carlton, Victoria, Australien, 3053
        • Health Services -University of Melbourne
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35242
        • Greystone Medical Research, LLC
      • Birmingham, Alabama, Forenede Stater, 35209
        • West Alabama Research, Inc.
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85016
        • NextCare Institute For Clinical Research
    • Arkansas
      • Jonesboro, Arkansas, Forenede Stater, 72401
        • NEA Clinic
      • Jonesboro, Arkansas, Forenede Stater, 72401
        • Clopton Clinic
      • Mountain Home, Arkansas, Forenede Stater, 72653
        • North Central Arkansas Medical Associates
    • California
      • Beverly Hills, California, Forenede Stater, 90211
        • Impact Clinical Trials
      • Carmichael, California, Forenede Stater, 95608
        • MedCenter
      • Paramount, California, Forenede Stater, 90723
        • Center for Clinical Trials, LLC
      • San Luis Obispo, California, Forenede Stater, 93405
        • Coastal Medical Research Group, Inc.
    • Colorado
      • Boulder, Colorado, Forenede Stater, 80304
        • Alpine Research Center
      • Centennial, Colorado, Forenede Stater, 80112
        • 1st Allergy and Clinical Research Center
    • Florida
      • Coral Gables, Florida, Forenede Stater, 33134
        • Clinical Research of South Florida
      • Jacksonville, Florida, Forenede Stater, 32205
        • Westside Center for Clinical Research
      • Jacksonville, Florida, Forenede Stater, 32216
        • Jacksonville Center for Clinical Research
      • Pembroke Pines, Florida, Forenede Stater, 33024
        • University Clinical Research, Inc.
      • Pinellas Park, Florida, Forenede Stater, 33782
        • DMI Research, Inc.
      • St. Cloud, Florida, Forenede Stater, 34769
        • Wilker/Powers Center for Clinical Studies, d/b/a ProHealth Clinical Studies
    • Georgia
      • Columbus, Georgia, Forenede Stater, 31904
        • Southeast Regional Research Group
      • Savannah, Georgia, Forenede Stater, 31406
        • Southeast Regional Research Group
      • Woodstock, Georgia, Forenede Stater, 30188
        • The Kaufmann Clinic, Inc.
    • Idaho
      • Idaho Falls, Idaho, Forenede Stater, 83404
        • Idaho Falls Infectious diseases
    • Illinois
      • Bloomingdale, Illinois, Forenede Stater, 60108
        • Dr. Arthur Davida
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46268
        • Investigators Research Group, Llc
    • Iowa
      • Dubuque, Iowa, Forenede Stater, 52001
        • Medical Associates Clinic
    • Kansas
      • Shawnee, Kansas, Forenede Stater, 66218
        • Heart of America Research
    • Kentucky
      • Hazard, Kentucky, Forenede Stater, 41701
        • Kentucky Lung Clinic
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Gulf Coast Research, LLC
    • Maine
      • Bangor, Maine, Forenede Stater, 44401
        • Acadia Clinical Research
    • Maryland
      • Clarksburg, Maryland, Forenede Stater, 20871
        • Clarksburg Medical Center
    • Massachusetts
      • Brockton, Massachusetts, Forenede Stater, 02301
        • Miray Medical Center
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Detroit Receiving Hospital, UHC 6G
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital
      • St. Claire Shores, Michigan, Forenede Stater, 48081
        • KMED Research
    • Mississippi
      • Olive Branch, Mississippi, Forenede Stater, 38654
        • Olive Branch Family Medical Center
    • Montana
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Urgent Care Center
      • Butte, Montana, Forenede Stater, 59701
        • Mercury Street Medical Group, PLLC
    • Nebraska
      • Fremont, Nebraska, Forenede Stater, 68025
        • Prairie Fields Family Medicine, P.C.
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Impact Clinical Trials, Las Vegas
    • New York
      • Johnson City, New York, Forenede Stater, 13790
        • United Medical Associates
      • Rochester, New York, Forenede Stater, 14618
        • Twelve Corners Internal Medicine
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27401
        • Bland Clinic
    • Ohio
      • Canfield, Ohio, Forenede Stater, 44515
        • Community Medical Associates, LLC
      • Thornville, Ohio, Forenede Stater, 43076
        • Advanced Health Care Services, Inc
    • Oklahoma
      • Owasso, Oklahoma, Forenede Stater, 74055
        • Urgent Care of Green County, PLLC
    • Oregon
      • Ashland, Oregon, Forenede Stater, 97520
        • Integrated Medical Research, PC
    • Pennsylvania
      • Souderton, Pennsylvania, Forenede Stater, 18964
        • Pivotal Clinical Research, Llc
    • Rhode Island
      • Cranston, Rhode Island, Forenede Stater, 02920
        • New England Center for Clinical Research, Inc.
      • Cumberland, Rhode Island, Forenede Stater, 02864
        • Notheast Clinical Research
      • Johnston, Rhode Island, Forenede Stater, 02919
        • Clinical Partners, LLC
      • Warwick, Rhode Island, Forenede Stater, 02886
        • Omega Medical Research
    • South Carolina
      • Simpsonville, South Carolina, Forenede Stater, 29681
        • Hillcrest Clinical Research, LLC
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57702
        • Health Concepts
    • Tennessee
      • Bristol, Tennessee, Forenede Stater, 37620
        • Holston Medical Group
    • Texas
      • Bryan, Texas, Forenede Stater, 77802
        • DiscoveResearch, Inc.
      • Corpus Christi, Texas, Forenede Stater, 78414
        • Corpus Christi Family Wellness Center, Research Division
      • Dallas, Texas, Forenede Stater, 75230
        • Allergy/Immunology Research Center of North Texas
      • Garland, Texas, Forenede Stater, 75041
        • Towngate Plaza Medical Center
      • Houston, Texas, Forenede Stater, 77055
        • West Houston Clinical Research
      • San Antonio, Texas, Forenede Stater, 78238
        • Texas Medical Research Associates, LLC
      • Tomball, Texas, Forenede Stater, 77375
        • Martin Diagnostic Clinic
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84088
        • J. Lewis Research, Inc., FirstMed
      • Salt Lake City, Utah, Forenede Stater, 84109
        • J. Lewis Research, Inc./Foothill Family Clinic South
      • Salt Lake City, Utah, Forenede Stater, 84121
        • J. Lewis Research, Inc./FirstMed East
      • Salt Lake City, Utah, Forenede Stater, 84121
        • J. Lewis Research, Inc./Foothill Family Clinic South
    • Washington
      • Bellevue, Washington, Forenede Stater, 98004
        • Northwest Clinical Research Center
    • Wisconsin
      • Oregon, Wisconsin, Forenede Stater, 53575
        • Dean Medical Center
  • New Zealand
      • Auckland, New Zealand
        • Greenhithe Medical Centre
      • Christchurch, New Zealand, 4737
        • St George's Hospital
      • Christchurch, New Zealand
        • Southern Clinical Trials Ltd
      • Dunedin, New Zealand
        • Caversham Medical Centre
      • Rotorua, New Zealand, 3010
        • Bairds Road Family Health Care
      • Rotorua, New Zealand
        • Dr. Gillies
      • Rotorua, New Zealand
        • Hinemoa House Family Health Centre
  • Sydafrika
      • Amanzimtoti, Sydafrika, 4126
        • Dr. van Rensburg
      • Benoni, Sydafrika, 1501
        • Benmed Park Clinic
      • Bloemfontein, Sydafrika, 9301
        • Jsha Research
      • Brits, Sydafrika, 0250
        • Armansis Medical Centre
      • Cape Town, Sydafrika, 7941
        • First House
      • Cape town, Sydafrika, 7490
        • Cape Clinical Trial, Bishop Lavis Day Hospital
      • Durban, Sydafrika, 4001
        • Synapta Clinical Research Centre
      • Durban, Sydafrika
        • Dr. Janari
      • Johannesburg, Sydafrika, 1820
        • Dr. Makan
      • Johannesburg, Sydafrika
        • Newgate Centre
      • Port Elizabeth, Sydafrika
        • GCT Trials, Mercantile Hospital no 9
      • Pretoria, Sydafrika, 0083
        • Dr. Nel
      • Pretoria, Sydafrika, 0084
        • Emmed Research
      • Pretoria, Sydafrika, 9585
        • Dr. de Bruin
      • Pretoria, Sydafrika
        • Westmed Clinical Trial Centre, Pretoria West Medicross Building
      • Roodepoort, Sydafrika, 1724
        • Dr. Fouche
      • Scottburgh, Sydafrika, 4182
        • Dr. de Villiers
      • Soweto, Sydafrika, 1818
        • Dr. Bhorat
      • Worcester, Sydafrika, 6850
        • Clinical Projects Research SA Ltd
    • Capetown
      • Goodwood, Capetown, Sydafrika, 7460
        • Nortje, MD
    • Durban
      • Greenbury, Durban, Sydafrika, 4068
        • Greenbury Medical Centre
      • Silverglen, Durban, Sydafrika, 4092
        • Sebastian, MD
    • Free State
      • Bloemfontein, Free State, Sydafrika, 9301
        • Quinta-research
    • Gauteg
      • Reigerpark, Gauteg, Sydafrika, 1459
        • Wilhase, AC
    • Gauteng
      • Bryanston, Gauteng, Sydafrika, 2191
        • NHC Medical Centre
      • Klipspruit West, Gauteng, Sydafrika, 1812
        • R. Dulabh, MD
    • KZ-Natal
      • Durban, KZ-Natal, Sydafrika, 4091
        • Vawda, Z.FA
    • Krugersdorp
      • Noordheuwel, Krugersdorp, Sydafrika, 1739
        • DJW Navorsing
    • Kwa Zulu Natal
      • Verulam, Kwa Zulu Natal, Sydafrika, 4340
        • Pillay, MD
    • Pretoria
      • Kempton Park, Pretoria, Sydafrika, 1619
        • le Clus, MD
      • Sunnyside Pretoria, Pretoria, Sydafrika, 0132
        • Sunnyside Medi-Clinic
    • W. Cape
      • Cape Town, W. Cape, Sydafrika, 7500
        • Kaapzicht Centre
      • Cape Town, W. Cape, Sydafrika, 7530
        • Syzygy SMO Intercare Medical and Dental Centre
      • Worcester, W. Cape, Sydafrika, 6850
        • Clinical Project Research SA (Pty) Ltd.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male and non-pregnant female subjects age ≥18 years.
  • A positive Influenza A 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 36 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.
  • 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.
  • 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 with the previous 7 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Peramivir 600 mg
600 mg peramivir administered as bilateral 2-mL intramuscular injection.
Medicin: Peramivir
600 mg peramivir administered as bilateral 2-mL intramuscular injection
Placebo komparator: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Medicin: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
Tidsramme: Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14
The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment.
Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Influenza Virus Shedding
Tidsramme: Baseline and Days 3, 4, 9
Changes from Baseline in log10 TCID50/mL through Days 3, 4, and 9 were presented by treatment group for subjects with positive viral titers at Baseline (log10 TCID50/mL >0.5).
Baseline and Days 3, 4, 9

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subject's Severity of Illness (Score*Hours)
Tidsramme: Information collected predose on Day 1 and then once daily through Day 14

A subject's severity of illness (area under the symptom score curve, as measured in score-hours) was assessed using available symptom score data until the time of alleviation of symptoms.The score-hours were calculated as the product of the daily symptom score times the hours to alleviation. All available data until time of alleviation were utilized.

The daily symptom score was defined as the sum of the 7 symptoms of influenza recorded by the subject in the diary each day (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue), each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]); for the composite score, individual scores were summed, with a range from 0 to 21.
Information collected predose on Day 1 and then once daily through Day 14
Time to Resolution of Fever
Tidsramme: Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14
Time to resolution of fever was defined as the number of hours from initiation of study drug until temperature was less than 37.2 °C (99.0 °F) and no antipyretic medication had been taken for at least 12 hours.
Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14
Incidence of Influenza-related Complications
Tidsramme: 14 days
Study personnel were provided with an IRC checklist in the CRF to evaluate the subject for the presence of clinical signs and/or symptoms of the following IRCs: sinusitis, otitis, bronchitis, and pneumonia. Subjects with clinical signs and/or symptoms consistent with these conditions at Screening were not eligible for enrollment in this study.
14 days
Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50)
Tidsramme: Baseline
Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates.
Baseline
Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50)
Tidsramme: Baseline and up to 14 days
Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype.
Baseline and up to 14 days
Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50)
Tidsramme: Baseline and up to 14 days
Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.
Baseline and up to 14 days
Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50)
Tidsramme: Baseline and up to 14 days
Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.
Baseline and up to 14 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

BioCryst Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2008

Primær færdiggørelse (Faktiske)

1. april 2009

Studieafslutning (Faktiske)

1. oktober 2009

Datoer for studieregistrering

Først indsendt

24. juni 2008

Først indsendt, der opfyldte QC-kriterier

25. juni 2008

Først opslået (Skøn)

26. juni 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. februar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. februar 2015

Sidst verificeret

1. februar 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BCX1812-212
  • HHS 0100200700032C (Andet bevillings-/finansieringsnummer: HHS-BARDA)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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