此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2015年2月12日 更新者：BioCryst Pharmaceuticals
The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

405

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Peramivir 600 mg
600 mg peramivir administered as bilateral 2-mL intramuscular injection.
药品：Peramivir
600 mg peramivir administered as bilateral 2-mL intramuscular injection
安慰剂比较：Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
药品：Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Change in Influenza Virus Shedding
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Subject's Severity of Illness (Score*Hours)
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

BioCryst Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年7月1日

初级完成 (实际的)

2009年4月1日

研究完成 (实际的)

2009年10月1日

研究注册日期

首次提交

2008年6月24日

首先提交符合 QC 标准的

2008年6月25日

首次发布 (估计)

2008年6月26日

研究记录更新

最后更新发布 (估计)

2015年2月16日

上次提交的符合 QC 标准的更新

2015年2月12日

最后验证

2015年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • BCX1812-212
  • HHS 0100200700032C (其他赠款/资助编号：HHS-BARDA)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Norway

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅