이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2015년 2월 12일 업데이트: BioCryst Pharmaceuticals
The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

405

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Peramivir 600 mg
600 mg peramivir administered as bilateral 2-mL intramuscular injection.
의약품: Peramivir
600 mg peramivir administered as bilateral 2-mL intramuscular injection
위약 비교기: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
의약품: Placebo
Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Influenza Virus Shedding
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Subject's Severity of Illness (Score*Hours)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

BioCryst Pharmaceuticals

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2008년 7월 1일

기본 완료 (실제)

2009년 4월 1일

연구 완료 (실제)

2009년 10월 1일

연구 등록 날짜

최초 제출

2008년 6월 24일

QC 기준을 충족하는 최초 제출

2008년 6월 25일

처음 게시됨 (추정)

2008년 6월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 2월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 2월 12일

마지막으로 확인됨

2015년 2월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BCX1812-212
  • HHS 0100200700032C (기타 보조금/기금 번호: HHS-BARDA)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다