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

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

405

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Comparador de placebos: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Droga: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Influenza Virus Shedding
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Subject's Severity of Illness (Score*Hours)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

BioCryst Pharmaceuticals

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2008

Finalización primaria (Actual)

1 de abril de 2009

Finalización del estudio (Actual)

1 de octubre de 2009

Fechas de registro del estudio

Enviado por primera vez

24 de junio de 2008

Primero enviado que cumplió con los criterios de control de calidad

25 de junio de 2008

Publicado por primera vez (Estimar)

26 de junio de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

16 de febrero de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

12 de febrero de 2015

Última verificación

1 de febrero de 2015

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BCX1812-212
  • HHS 0100200700032C (Otro número de subvención/financiamiento: HHS-BARDA)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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