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

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

405

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Peramivir 600 mg
600 mg peramivir administered as bilateral 2-mL intramuscular injection.
Lék: Peramivir
600 mg peramivir administered as bilateral 2-mL intramuscular injection
Komparátor placeba: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Lék: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Influenza Virus Shedding
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Subject's Severity of Illness (Score*Hours)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

BioCryst Pharmaceuticals

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. července 2008

Primární dokončení (Aktuální)

1. dubna 2009

Dokončení studie (Aktuální)

1. října 2009

Termíny zápisu do studia

První předloženo

24. června 2008

První předloženo, které splnilo kritéria kontroly kvality

25. června 2008

První zveřejněno (Odhad)

26. června 2008

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

16. února 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. února 2015

Naposledy ověřeno

1. února 2015

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • BCX1812-212
  • HHS 0100200700032C (Jiné číslo grantu/financování: HHS-BARDA)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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