Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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 febbraio 2015 aggiornato da: BioCryst Pharmaceuticals
The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

405

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Peramivir 600 mg
600 mg peramivir administered as bilateral 2-mL intramuscular injection.
Droga: Peramivir
600 mg peramivir administered as bilateral 2-mL intramuscular injection
Comparatore placebo: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Droga: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Influenza Virus Shedding
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Subject's Severity of Illness (Score*Hours)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

BioCryst Pharmaceuticals

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2008

Completamento primario (Effettivo)

1 aprile 2009

Completamento dello studio (Effettivo)

1 ottobre 2009

Date di iscrizione allo studio

Primo inviato

24 giugno 2008

Primo inviato che soddisfa i criteri di controllo qualità

25 giugno 2008

Primo Inserito (Stima)

26 giugno 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

16 febbraio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 febbraio 2015

Ultimo verificato

1 febbraio 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BCX1812-212
  • HHS 0100200700032C (Altro numero di sovvenzione/finanziamento: HHS-BARDA)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi