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BUILD 3: Bosentan Use in Interstitial Lung Disease (BUILD 3)

9. september 2015 opdateret af: Actelion

Effects of Bosentan on Morbidity and Mortality in Patients With Idiopathic Pulmonary Fibrosis - a Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Group Sequential, Phase III Study.

BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, event-driven, group sequential, phase III superiority study. The primary objective is to demonstrate that bosentan delays disease worsening or death in patients with Idiopathic Pulmonary Fibrosis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

616

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • New South Wales
      • Darlinghurst, New South Wales, Australien, 2010
        • St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine
    • Queensland
      • Chermside, Queensland, Australien, 4032
        • Prince Charles Hospital - Lung Transplant, Thoraic Dept.
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Royal Adelaide Hospital-Respiratory Clinical Trials Unit
    • Western Australia
      • Perth, Western Australia, Australien, 6000
        • Royal Perth Hospital; Advanced Lung Disease Unit
  • Belgien
      • Leuven, Belgien, 3000
        • Uz Gasthuisberg
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Walter C. Mackenzie Health Sciences Centre-Univeristy of Alberta
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • The Health Care Corporation of St. John's-Eastern Health
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare
      • London, Ontario, Canada, N6A 4G5
        • Lawson Health Research Institute
      • Toronto, Ontario, Canada, M4X 1W4
        • Toronto General Hospital-Rosedale Medical Center PFT Lab
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Hopital Notre Dame - Centre Hospitalier de L'Universit de Montreal
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • Institut de Cardiologie et de Pneumologie de l'Universite Laval
  • Det Forenede Kongerige
      • Aberdeen, Det Forenede Kongerige, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Bristol, Det Forenede Kongerige, BS10 5NB
        • Southmead Hospital
      • Cambridge, Det Forenede Kongerige, CB23 3RE
        • Papworth Hospital
      • London, Det Forenede Kongerige, SW3 6NP
        • Royal Brompton Hospital
      • Manchester, Det Forenede Kongerige, M23 9LT
        • NWLC, Wythenshawe Hospital
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • UAB Division of Pulmonary
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Pulmonary Associates
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Mayo Clinic
    • California
      • Los Angeles, California, Forenede Stater, 90033
        • USC University Hospital
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA-Division of Pulmonary & Critical Care
      • Sacramento, California, Forenede Stater, 95817
        • UC Davis University of California
      • San Diego, California, Forenede Stater, 92103
        • UCSD Medical Center
      • San Francisco, California, Forenede Stater, 94143
        • UCSF-Interstitial Lung Disease Center
      • Stanford, California, Forenede Stater, 94305
        • Pulmonary and Critical Care Medicine-Stanford University Medical Center
    • Colorado
      • Denver, Colorado, Forenede Stater, 80206
        • National Jewish Medical & Research Center
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale University School of Medicine-Dept of Internal Med-Pulmonary & Critical Care
    • Florida
      • Brandon, Florida, Forenede Stater, 33511
        • PAB Clinical Research
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago - Section of Pulmonary, Dept of Medicine, Respiratory Clinical Research
    • Kansas
      • Olathe, Kansas, Forenede Stater, 66061
        • Consultants in Pulmonary Medicine
      • Wichita, Kansas, Forenede Stater, 67208
        • Wichita Clinic, P.A.
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston University School Of Medicine
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic
    • Missouri
      • Chesterfield, Missouri, Forenede Stater, 63017
        • St. Luke's Medical Group, Cardio-Pulmonary Research
    • New Jersey
      • Summit, New Jersey, Forenede Stater, 07901
        • Pulmonary & Allergy Associates, P.A.
    • New York
      • New York, New York, Forenede Stater, 10029-6574
        • Mount Sinai School of Medicine
      • Rochester, New York, Forenede Stater, 14620
        • Highland Hospital - Pulmonary Department
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
        • University of Cincinnati
      • Cleveland, Ohio, Forenede Stater, 44195
        • The Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania Medical Center
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232-5735
        • Vanderbilt Medical Center - IPF Center
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • University of Texas-Southwestern Dallas-Div. of Pulm & Critical Care Unit
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84108
        • University of Utah
    • Vermont
      • Colchester, Vermont, Forenede Stater, 05446
        • Vermont Lung Center
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • University of Virginia - Div. of Pulmonary & Critical Care
      • Falls Church, Virginia, Forenede Stater, 22042
        • Inova Heart and Vascular Institute
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792-3240
        • University of Wisconsin-Madison
  • Frankrig
      • Bobigny, Frankrig, 93009
        • Hôpital Avicenne
      • Bron, Frankrig, 69677
        • Hôpital Louis Pradel
      • Grenoble, Frankrig, 38100
        • HYLAB, Clinique du Mail
      • Lille Cedex, Frankrig, 59037
        • CHRU de Lille-Hôpital Albert Calmette
      • Montpellier, Frankrig, 34295
        • CHU Hôpital Arnaud de Villeneuve
      • Paris, Frankrig, 75877
        • Hopital Bichat
  • Holland
      • Amsterdam, Holland, 1105 AZ
        • Academisch Medisch Centrum Amsterdam
  • Irland
      • Dublin 7, Irland
        • Mater Misicordiae Hospital
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Centre-Div. for Pulmonary Disease
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization: Ein Karem-Institute of Pulmonology
      • Petach Tikvah, Israel
        • Pulmonary Istitute-Rabin Medical Centre: Beilinson Campus
      • Rehovot, Israel, 76100
        • Kaplan Medical Centre-Pulmoary Istitute
      • Tel-Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Centre-Institute of Pulmonary & Allergic Diseases
      • Tel-Hashomer, Israel, 52621
        • Chaim Sheba Medical Centre
  • Italien
      • Forli, Italien, 47100
        • Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento
      • Milan, Italien, 20123
        • Ospedale San Giuseppe Milanocuore, Unita Operativa di Pneumologia
      • Orbassano (Torino), Italien, 10043
        • Azienda Ospedaliero-Universitaria San Luigi Gonzaga
      • Padova, Italien, 35128
        • Azienda Ospedaliera di Padova - Immunologia Clinica
      • Palermo, Italien, 90127
        • Pneumologia ISMETT
      • Siena, Italien, 53100
        • University degli Studi Siena, Policlinico le Scotte
  • Japan
    • Aichi
      • Seto, Aichi, Japan, 489-8642
        • Tosei General Hospital
    • Hyogo
      • Himeji, Hyogo, Japan, 670-8520
        • Himeji Medical Center
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0051
        • Kanagawa Cardiovascular Respiratory Center
    • Nara
      • Tenri, Nara, Japan, 632-8552
        • Tenri Hospital
    • Osaka
      • Sakai, Osaka, Japan, 591-8555
        • Kinki - Chuo Chest Medical Center
  • Korea, Republikken
      • Incheon, Korea, Republikken, 405-760
        • Gil Medical Centre, Gachon University
      • Seoul, Korea, Republikken, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republikken, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republikken, 135-710
        • Samsung Medical Centre
      • Seoul, Korea, Republikken, 420-767
        • SoonChunHyang University Bucheon Hospital
  • Kroatien
      • Zagreb, Kroatien, 10000
        • University Hospital for Lung Disease "Jordanovac"
  • Schweiz
      • Basel, Schweiz, 4031
        • University Hospital Basel-Div of Pneumology
      • Bern, Schweiz, 3010
        • Inselspital Bern-Div of Pulmonary Medicine
      • Zurich, Schweiz, 8091
        • University Hopital Zurich-Clinic for Pneumology & Lung Transplant Program
  • Serbien
      • Belgrade, Serbien, 11000
        • Institut za Plucne bolest l TBC Klinickog Centra Srbije
      • Sremska Kamenica, Serbien, 21204
        • Institut za Plucne bolesti Vojvodine, Sremska Kamenica
  • Spanien
      • Barcelona, Spanien, 08036
        • Hospital Clinic Barcelona (Pneumology Service)
      • Barcelona, Spanien, 08035
        • Hospital Vall d'Hebron-Neumologia
      • Madrid, Spanien, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spanien, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spanien, 28006
        • Hospital La Princesa
      • Valencia, Spanien, 46014
        • Hospital General de Valencia
      • Valencia, Spanien, 46017
        • Hospital Universitario Dr. Peset
  • Tjekkiet
      • Olomouc, Tjekkiet, 775 20
        • University Hospital Olomouc - Dept of Respiratory Disease-IP Pavlova
      • Praha 4, Tjekkiet, 140 59
        • Thomayer Faculty Hospital Prague-Dept of Respiratory Disease
      • Praha 8, Tjekkiet, 180 81
        • University Hospital Na Bulovce
  • Tyskland
      • Berlin, Tyskland, D-14165
        • Helios Klinikum Emil Von Behring
      • Coswig, Tyskland
        • Fachkrankenhaus Coswig; Centre for Pulmonology and Thoracic Surgery
      • Donaustauf, Tyskland, 93093
        • Klinik Donaustauf-Zentrum für Pneumologie
      • Essen, Tyskland, 45239
        • Ruhrlandklinik, Pneumologie/Allergologie
      • Freiburg, Tyskland, 79106
        • Medizinische Universitätsklinik, Abteilung Pneumologie
      • Giessen, Tyskland, 35392
        • Justus-Liebig-Universitat Giessen-Zentrum für Innere Medizin
      • Heidelberg, Tyskland, 01640
        • Thoraxklinik Heidelberg GmbH
      • Immenhausen, Tyskland
        • Fachklinik für Lungenerkrankungen
      • Löwenstein, Tyskland, 74245
        • Klinik Löwenstein GmbH-Medizinische Klinik 1 Pneumologie-Kardiologie
      • Munich, Tyskland, 81377
        • Klinikum der Universität München Medizinische Klinik und Poliklinik 1 - Grosshadern
  • Østrig
      • Graz, Østrig, 8036
        • Medizinische Universität Graz-Klinische Abteilung für Pulmonologie
      • Grimmenstein, Østrig, 2840
        • Landesklinikum Thermenregion Hochegg
      • Innsbruck, Østrig, 6020
        • Medical University of Innsbruck-Div. of Clinical & Internal Medicine
      • Wien, Østrig, 1090
        • Medical University of Vienna and AKH-Div of Pulmonology
      • Wien, Østrig, 1140
        • Otto-Wagner Spital Wien

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Signed informed consent
  • Male or female aged 18 years or older (females of child-bearing potential must have been surgically sterilized or use a reliable method of contraception.)
  • Proven diagnosis of IPF according to American Thoracic Society / European Respiratory Society (ATS-ERS) statement, of <3 years, with surgical lung biopsy (SLB)

Exclusion Criteria:

  • Interstitial lung disease due to conditions other than IPF.
  • Presence of extensive honeycombing (HC) on baseline high-resolution computed tomography (HRCT) scan.
  • Severe concomitant illness limiting life expectancy (<1 year).
  • Severe restrictive lung disease.
  • Obstructive lung disease.
  • Diffusing capacity of the lung for carbon monoxide <30% predicted.
  • Residual volume > or = 120% predicted.
  • Documented sustained improvement of patient's IPF condition up to 12 months prior to randomization with or without IPF-specific therapy.
  • Recent pulmonary or upper respiratory tract infection (up to 4 weeks prior to randomization).
  • Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements.
  • Chronic heart failure with New York Heart Association (NYHA) class III/IV or known left ventricular ejection fraction <25%.
  • Alanine aminotransferase (ALT/SGPT) and/or aspartate aminotransferase (AST/SGOT) > 1.5 times the upper limit of the normal ranges.
  • Moderate to severe hepatic impairment.
  • Serum creatinine > or = 2.5 mg/dl or chronic dialysis.
  • Hemoglobin concentration <75% the lower limit of the normal ranges.
  • Systolic blood pressure <85 mmHg.
  • Pregnancy or breast-feeding.
  • Current drug or alcohol dependence.
  • Chronic treatment with the following drugs prescribed for IPF (within 4 weeks of randomization):oral corticosteroids (>20 mg/day of prednisone or equivalent), immunosuppressive or cytotoxic drugs, antifibrotic drugs, chronic use of N-acetylcysteine (prescribed for IPF).
  • Oral anticoagulants other than those indicated for a venous or arterial thrombotic disease.
  • Treatment with glibenclamide (glyburide) and calcineurin inhibitors (cyclosporine A, tacrolimus) up to 1 week prior to randomization.
  • Treatment with an endothelin receptor antagonist up to 3 months prior to randomization.
  • Participation in the BUILD 1 trial.
  • Treatment with another investigational drug up to 3 months prior to randomization or planned treatment.
  • Known hypersensitivity to bosentan or any of the excipients.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Bosentan
Subjects receive bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg b.i.d (if body weight > 40 kg) or bosentan 62.5 mg b.i.d. (if body weight < 40 kg)
Medicin: Bosentan
Bosentan 62.5 mg tablets twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg tablets b.i.d (if body weight > 40 kg) or bosentan 62.5 mg tablets b.i.d. (if body weight < 40 kg)
Andre navne:
  • ACT-050088
  • Ro 47-0203
Placebo komparator: Placebo
Subjects receive placebo matching the bosentan treatment regimen
Medicin: Placebo
Placebo matching bosentan 62.5 mg tablets and 125 mg tablets

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Occurrence of Disease Worsening or Death up to End of Study.
Tidsramme: 36 months
Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).
36 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year.
Tidsramme: 12 months
Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Actelion

Efterforskere

  • Studieleder: Isabelle Leconte, Actelion

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2007

Primær færdiggørelse (Faktiske)

1. februar 2010

Studieafslutning (Faktiske)

1. juli 2010

Datoer for studieregistrering

Først indsendt

20. oktober 2006

Først indsendt, der opfyldte QC-kriterier

20. oktober 2006

Først opslået (Skøn)

24. oktober 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AC-052-321

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Bosentan

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bulgaria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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