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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

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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

405

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Peramivir 600 mg
600 mg peramivir administered as bilateral 2-mL intramuscular injection.
薬：Peramivir
600 mg peramivir administered as bilateral 2-mL intramuscular injection
プラセボコンパレーター：Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
薬：Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Influenza Virus Shedding
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Subject's Severity of Illness (Score*Hours)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

BioCryst Pharmaceuticals

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2008年7月1日

一次修了 (実際)

2009年4月1日

研究の完了 (実際)

2009年10月1日

試験登録日

最初に提出

2008年6月24日

QC基準を満たした最初の提出物

2008年6月25日

最初の投稿 (見積もり)

2008年6月26日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年2月16日

QC基準を満たした最後の更新が送信されました

2015年2月12日

最終確認日

2015年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • BCX1812-212
  • HHS 0100200700032C (その他の助成金/資金番号：HHS-BARDA)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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