Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443

Last updated: January 31, 2025
Sponsor: Actelion
Overall Status: Completed

Phase

3

Condition

Idiopathic Pulmonary Fibrosis

Pulmonary Fibrosis

Cystic Fibrosis

Treatment

Bosentan

Clinical Study ID

NCT00631475
AC-052-322
  • Ages > 18
  • All Genders

Study Summary

This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients should have completed all the assessments from the BUILD 3 (NCT00391443) end of study (EOS) visit.

  • Signed informed consent prior to initiation of any study-related procedures.

  • Women of childbearing potential must have a negative serum pregnancy test and usereliable methods of contraception during study treatment and for 3 months afterstudy treatment termination.

Exclusion

Exclusion Criteria:

  • Any major violation of protocol AC-052-321 / BUILD 3 (NCT00391443).

  • Pregnancy or breast-feeding.

  • AST and/or ALT > 3 times the upper limit of the normal range.

  • Any known factor or disease that might interfere with treatment compliance, studyconduct or interpretation of the results, such as drug or alcohol dependence orpsychiatric disease.

  • Known hypersensitivity to bosentan or any of the excipients.

Study Design

Total Participants: 128
Treatment Group(s): 1
Primary Treatment: Bosentan
Phase: 3
Study Start date:
April 01, 2008
Estimated Completion Date:
May 31, 2010

Connect with a study center

  • St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Prince Charles Hospital- Lung Transplant, Thoraic Dept.

    Chermside, Queensland 4032
    Australia

    Site Not Available

  • Royal Adelaide Hospital-Respiratory Clinical Trials Unit

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Royal Perth Haspital; Advanced Lung Disease Unit

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • Landesklinikum Thermenregion Hochegg

    Grimmenstein, 2840
    Austria

    Site Not Available

  • Medical University of Innsbruck-Dic of Clinical & Internal Medicine

    Innsbruck, 6020
    Austria

    Site Not Available

  • Medical University of Vienna and AKH-Div of Pulmonology

    Wien, 1090
    Austria

    Site Not Available

  • UZ Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • Walter C. Mackenzie Health Sciences Centre-University of Alberta

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • The Health Care Corporation of St. John's-Eastern Health

    St. John's, Newfoundland and Labrador A1B 3V6
    Canada

    Site Not Available

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • Lawson Health Research Institute

    London, Ontario N6A 4G5
    Canada

    Site Not Available

  • Toronto General Hospital-Rosedale Medical Center PFT Lab

    Toronto, Ontario M4X 1W4
    Canada

    Site Not Available

  • Institut de Cardiologie et de Pneumologie de l'Universite Laval

    Ste-Foy, Quebec G1V 4G5
    Canada

    Site Not Available

  • University Hospital for Lung Disease "Jordanovac"

    Zagreb, 10000
    Croatia

    Site Not Available

  • University Hospital-Department of Respiratory Disease-IP Pavlova

    Olomouc, 77520
    Czech Republic

    Site Not Available

  • Thomayer Faculty Hospital Prague-Dept of Respiratory Disease

    Praha 4, 140 59
    Czech Republic

    Site Not Available

  • University Hospital Na Bulovce

    Praha 8, 180 81
    Czech Republic

    Site Not Available

  • Hopital Avicenne

    Bobigny, 93009
    France

    Site Not Available

  • Hopital Louis Pradel

    Bron, 69677
    France

    Site Not Available

  • HYLAB, Clinique du Mail

    Grenoble, 38100
    France

    Site Not Available

  • CHRU de Lille-Hopital Albert Calmette

    Lille Cedex, 59037
    France

    Site Not Available

  • CHU Hôpital Arnaud de Villeneuve

    Montpellier, 34295
    France

    Site Not Available

  • Hopital Bichat

    Paris, 75877
    France

    Site Not Available

  • HELIOS Klinikum Emil von Behring

    Berlin, D-14165
    Germany

    Site Not Available

  • Fachkrankenhaus Coswig; Centre for Pumonology and Thoracic Surgery

    Coswig,
    Germany

    Site Not Available

  • Klinik Donaustauf-Zentrum für Pneumologie

    Donaustauf, 93093
    Germany

    Site Not Available

  • Ruhrlandklinik Pneumologie/Allergologie

    Essen, 45239
    Germany

    Site Not Available

  • Justus-Liebig-Universitat Giessen-Zentrum für Innere Medizin

    Giessen, 35392
    Germany

    Site Not Available

  • Thoraxklinik Heidelberg GmbH

    Heidelberg, 01640
    Germany

    Site Not Available

  • Lungenfachklinik Immenhausen; Pneumologische Lehrklinik der Universität Göttingen

    Immenhausen,
    Germany

    Site Not Available

  • Klinik Löwenstein GmbH-Medizinische Klinik 1 Pnemologie Kardiologie

    Löwenstein, 74245
    Germany

    Site Not Available

  • Klinik Löwenstein GmbH-Medizinische Klinik 1 Pnemologie Kardiologie

    Löwenstein, 74245
    Germany

    Site Not Available

  • SKlinikum der Universität München Medizinische Klinik und Poliklinik 1 - Grosshadern

    Munich, 81377
    Germany

    Site Not Available

  • Mater Misicordiae University Hospital

    Dublin, 7
    Ireland

    Site Not Available

  • Rambam Medical Centre-Div. for Pulmonary Disease

    Haifa, 31096
    Israel

    Site Not Available

  • Hadassah medical Centrte: Ein Karem-Institue of Pulmonology

    Jerusalem, 91120
    Israel

    Site Not Available

  • Pulmonary Institute-Rabin Medical Center: Beilinson Campus

    Petach Tikvah, 49100
    Israel

    Site Not Available

  • Kaplan Medical Centre-Pulmonary Istitute

    Rehovot, 76100
    Israel

    Site Not Available

  • Tel-Aviv Sourasky Medical Centre-Institute of Pulmonary & Allergy Diseases

    Tel-Aviv, 64239
    Israel

    Site Not Available

  • Sheba Medical Centre-Pulmonology Institute

    Tel-Hashomer, 52621
    Israel

    Site Not Available

  • Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento

    Forli, 47100
    Italy

    Site Not Available

  • Ospedale San Giuseppe Milanocuore, Unita Operativa di Pneumologia

    Milan, 20123
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano (Torino), 10043
    Italy

    Site Not Available

  • Azienda Ospedaliera di Padova - Immunologia Clinica

    Padova, 35128
    Italy

    Site Not Available

  • Pneumologia ISMETT

    Palermo, 90127
    Italy

    Site Not Available

  • University degli Studi Siena, Policlinico le Scotte

    Siena, 53100
    Italy

    Site Not Available

  • Tosei General Hospital

    Seto, Aichi 489-8642
    Japan

    Site Not Available

  • Himeji medical center

    Himeji, Hyogo 670-8520
    Japan

    Site Not Available

  • Kanagawa Cardiovascular Respiratory Center

    Yokohama, Kanagawa 236-0051
    Japan

    Site Not Available

  • Tenri Hospital

    Tenri, Nara 632-8552
    Japan

    Site Not Available

  • Kinki - Chuo Chest Medical Center

    Sakai, Osaka 591-8555
    Japan

    Site Not Available

  • Gil Medical Centre, Gachon University

    Incheon, 405-760
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 138-736
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • Academisch Medisch Centrum Amsterdam

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Institut za Plucne bolest 1 TBC Klinickog Centra Srbije

    Belgrade, 11000
    Serbia

    Site Not Available

  • Institut za Plucne bolesti Vojodine

    Sremska Kamenica, 21204
    Serbia

    Site Not Available

  • Hospital Clinic Barcelona (Pneumology Service)

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital General de Valencia

    Valencia, 46014
    Spain

    Site Not Available

  • University Hospital Basel-Div of Pneumology

    Basel, 4031
    Switzerland

    Site Not Available

  • Inselspital Bern-Div of Pulmonary Medicine

    Bern, 3010
    Switzerland

    Site Not Available

  • University Hospital Zurich-Clinic for Pneumology & Lung Transplant Program

    Zurich, 8091
    Switzerland

    Site Not Available

  • Aberdeen Royal Infirmary

    Aberdeen, AB252ZN
    United Kingdom

    Site Not Available

  • Southmead Hospital

    Bristol, BS105NB
    United Kingdom

    Site Not Available

  • Papworth Hospital

    Cambridgeshire, CB23 3RE
    United Kingdom

    Site Not Available

  • Royal Brompton Hospital

    London,
    United Kingdom

    Site Not Available

  • Wythenshawe Hospital

    Manchester, M23 9LT
    United Kingdom

    Site Not Available

  • UAB Division of Pulmonary

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Pulmonary Associates

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Mayo Clinic

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • UCLA- Division of Pulmonary & Critcal Care

    Los Angeles, California 90095
    United States

    Site Not Available

  • UC Davis University of California

    Sacramento, California 95817
    United States

    Site Not Available

  • UCSD Medical Center

    San Diego, California 92103
    United States

    Site Not Available

  • USCF-Interstitial Lung Disease Center

    San Francisco, California 94143
    United States

    Site Not Available

  • Pulmoary and Critical Care Medicine-Stanford University Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • National Jewish Medical & Research Center

    Denver, Colorado 80206
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • PAB Clinical Research

    Brandon, Florida 33511
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois
    United States

    Site Not Available

  • Consultants in Pulmonary Medicine

    Olathe, Kansas 66061
    United States

    Site Not Available

  • Wichita Clinic, P.A.

    Wichita, Kansas 67208
    United States

    Site Not Available

  • Beth Israel Deaconness Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • St. Luke's Medical Group, Cardio-Pulmonary Research

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Pulmonary & Allergy Associates PA

    Summit, New Jersey 07901
    United States

    Site Not Available

  • Mount Sinai School of Medicine

    New York, New York 10029-6574
    United States

    Site Not Available

  • Duke University-ID/Pulmonary Research-Park garage 2; Room 0002

    Durham, North Carolina 27710
    United States

    Site Not Available

  • University of Cinicinnati

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Vanderbilt Medical Center- IPF Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • University of Texas-Southwestern Dallas-Div of Pulm & Critical Care Unit

    Dallas, Texas 75390
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • Vermont Lung Center

    Colchester, Vermont 05446
    United States

    Site Not Available

  • Inova Heart and Vascular Institute

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

  • University of Wisconsin-Madison

    Madison, Wisconsin 53792-3240
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.