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

Condition(s) targeted: Idiopathic Pulmonary Fibrosis

Intervention: Bosentan (Drug)

Phase: Phase 3

Status: Enrolling by invitation

Sponsored by: Actelion

Official(s) and/or principal investigator(s):
Isabelle Leconte, Study Chair, Affiliation: Actelion

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

Official title: Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Primary outcome: Asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF)

Secondary outcome:

AE's leading to discontinuation of study drug

Treatment-emergent SAE's

Occurrence of LFT (ALT and AST) abnormality

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

Patients should have completed all the assessments from the BUILD 3 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 use

reliable methods of contraception during study treatment and for 3 months after study treatment termination.

Exclusion Criteria:

- Any major violation of protocol AC-052-321 / BUILD 3.

- 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, study

conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.

- Known hypersensitivity to bosentan or any of the excipients.

Royal Perth Haspital, Perth 5000, Australia

Otto-Wagner Spital Wien, Wien 1140, Austria

Medizinische Universitat Graz-Klinische Abteilung fur Pulmonologie, Graz 8036, Austria

Medical University of Vienna and AKH-Div of Pulmonology, Wien 1090, Austria

Medical University of Innsbruck-Dic of Clinical & Internal Medicine, Innsbruck 6020, Austria

Landesklinikum Thermenregion Hochegg, Grimmenstein 2840, Austria

UZ Gasthuisberg, Leuven 3000, Belgium

Toronto General Hospital-Rosedale Medical Center PFT Lab, Toronto M4X 1W4, Canada

University Hospital for Lung Disease "Jordanovac", Zagreb 10000, Croatia

Thomayer Faculty Hospital Prague-Dept of Respiratory Disease, Praha 414059, Czech Republic

University Hospital-Department of Respiratory Disease-IP Pavlova, Olomouc 77520, Czech Republic

Klinika Pneumologie a Hrudni Chrugie, Praha 818081, Czech Republic

Hopital Louis Pradel, Bron 69677, France

Hopital Avicenne, Bobigny 93009, France

Hopital Avicenne, Bobigny 93009, France

HYLAB, Clinique du Mail, Grenoble 38100, France

Hopital Bichat, Paris 75877, France

CHRU de Lille-Hopital Albert Calmette, Lille Cedex 59037, France

Schwerpunkt Pnemologie-Medizinische Klinik und Poliklinik 1, Munich 81377, Germany

Justus-Liebig-Universitat GieBen-Zentrum fur Innere Medizin, GieBen 35392, Germany

Klinik Lowenstein GmbH-Medizinische Klinik 1 Pnemologie Kariologie, Lowenstein 74245, Germany

Ruhrlandklinik Pnemologie/ Alergologie, Essen 45239, Germany

HELIOS Klinikum Emil von Behring-Lungenfachklinik Heckeshorn - Klinik fur Pneumologie, Berlin D-14165, Germany

Fachklinik fur Lungenerkrankungen, Immenhausen D-34376, Germany

Chefarzt der Abteilung Pneumologie; Thoraxklinik am Universitätsklinikum Heidelberg, Heidelberg 69126, Germany

Lungenfachklinik Immenhausen; Pneumologische Lehrklinik der Universität Göttingen, Immenhausen, Germany

Fachkrankenhaus Coswig; Centre for Pumonology and Thoracic Surgery, Coswig D- 01640, Germany

Mater Misicordiae University Hospital, Dublin 7, Ireland

Sheba Medical Centre-Pulmonology Institute, Tel-Hashomer 52621, Israel

Kaplan Medical Centre-Pulmonary Istitute, Rehovot 76100, Israel

Rabin Medical Centre-Beilinson Campus-Pulmonary Istitute, Petach Tikvah 49100, Israel

Hadassah medical Centrte: Ein Karem-Institue of Pulmonology, Jerusalem 91120, Israel

Tel-Aviv Sourasky Medical Centre-Institute of Pulmonary & Allergy Diseases, Tel-Aviv 64239, Israel

Rambam Medical Centre-Div. for Pulmonary Disease, Haifa 31096, Israel

Pulmonary Institute-Rabin Medical Center: Beilinson Campus, Petach Tikvah 49100, Israel

Iniversita degli di Torino- A. S. O. San Luigi Gonzaga, Torino 10043, Italy

Universita delgi Studi di Padova-Immunologia Clinica, Padova 35128, Italy

Unita Operativa di Pnemolgia, Ospedale San Giuseppe, Milan 20123, Italy

Pneumologia ISMETT, Palermo 90127, Italy

Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento, Forli 47100, Italy

Divisione di Malattie Respiratorie, Siena 53100, Italy

Samsung Medical Center, Seoul, Korea, Republic of

Gachon University Gil Medical Center, Incheon, Korea, Republic of

Asan Medical Center, Seoul 138-736, Korea, Republic of

Seoul National University Hospital, Seoul 110-744, Korea, Republic of

Soon Chun Hyang University Bucheon Hospital, Gyeonggi-do 420-767, Korea, Republic of

ERamus medisch centrum-University Medical Center Rotterdam, Rotterdam 3015 GD, Netherlands

Eramus Medisch Centrum- University medical Center Rotterdam, Rotterdam 3015 GD, Netherlands

Academisch Medisch Centrum Amsterdam, Amsterdam 1105 AZ, Netherlands

Institut za Plucne bolest 1 TBC Klinickog Centra Srbije, Belgrade 11000, Serbia and Montenegro

Institut za Plucne bolesti Vojodine, Sremska Kamenica 21204, Serbia and Montenegro

Vojnomedicinska Akademija (Military Medical Academy), Belgrade 1100, Serbia and Montenegro

Hospital La Princesa, Madrid 28006, Spain

Hospital General de Valencia, Valencia 46014, Spain

Hospital Ramon Y Cajal, Madrid 28034, Spain

Hospital General Vall d'Hebron-Neumologia Planta Baja.Hospital General, Barcelona 08035, Spain

Hospital Universitario Perta del mar, Cadiz 11009, Spain

Hospital Dr. Peset, Valencia 46017, Spain

Hospital Clinico San Carlos, Madrid 28040, Spain

Hospital Clinic Barcelona (Pneumology Service), Barcelona 08036, Spain

University Hospital Zurich- Clinic for Pneumology & Lung Transplant Program, Zurich 8091, Switzerland

Inselspital Bern-Div of Pulmonary Medicine, Bern 3010, Switzerland

University Hospital Basel-Div of Pneumology, Basel 4031, Switzerland

Wythenshawe Hospital, Manchester M23 9LT, United Kingdom

Southmead Hospital, Bristol BS105NB, United Kingdom

Aberdeen Royal Infirmary, Aberdeen AB252ZN, United Kingdom

Papworth Hospital, Cambridgeshire CB23 3RE, United Kingdom

Royal Brompton Hospital, London, United Kingdom

UAB Division of Pulmonary, Birmingham, Alabama 35294, United States

Walter C. Mackenzie Health Sciences Centre-University of Alberta, Edmonton, Alberta T6G 2B7, Canada

Mayo Clinic, Scottsdale, Arizona 85259, United States

St. Paul's Hospital - Pacific Lung Research Center, Vancouver, British Columbia V6Z 1Y6, Canada

Kelowna General Hospital, Kelowna, British Columbia V1YE4, Canada

USCF-Interstitial Lung Disease Center, San Francisco, California 94143, United States

Pulmoary and Critical Care Medicine-Stanford University Medical Center, Stanford, California 94305, United States

UCSD Medical Center, San Diego, California 92103, United States

UCLA- Division of Pulmonary & Critcal Care, Los Angeles, California 90095, United States

UC Davis University of California, Sacramento, California 95817, United States

CHU Hopital Arnaud de Villeneuve, Montpellier, Cedex 5 34295, France

National Jewish Medical & Research Center, Denver, Colorado 80206, United States

Yale University School of Medicine, New Haven, Connecticut 06520, United States

PAB Clinical Research, Brandon, Florida 33511, United States

Emory University, Atlanta, Georgia 30322, United States

Wichita Clinic, P.A., Wichita, Kansas 67208, United States

Consultants in Pulmonary Medicine, Olathe, Kansas 66061, United States

Boston University School of Medicine, Boston, Massachusetts 02118, United States

Beth Israel Deaconness Medical Center, Boston, Massachusetts 02215, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

University of Minnesota, Minneapolis, Minnesota 55455, United States

St. Luke's Medical Group, Cardio-Pulmonary Research, Chesterfield, Missouri 63017, United States

Pulmonary & Allergy Associates PA, Summit, New Jersey 07901, United States

Highland Hospital - Pulmonary Department, Rochester, New York 14602, United States

Mount Sinai School of Medicine, New York, New York 10029-6574, United States

The Health Care Corporation of St. John's-Eastern Health, St. John's, Newfoundland and Labrador A1B 3V6, Canada

Duke University-ID/Pulmonary Research-Park garage 2; Room 0002, Durham, North Carolina 27710, United States

Medical University of South Carolina, Charleston, North Carolina 29425, United States

University of Cinicinnati, Cincinnati, Ohio 45267, United States

The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

Lawson Health Research Institute, London, Ontario N6A 4G5, Canada

Temple University, Philadelphia, Pennsylvania 19140, United States

University of Pennsylvania Medical Center, Philadelphia, Pennsylvania 19104, United States

Institut de Cardiologie et de Pneumologie de l'Universite Laval, Ste-Foy, Quebec G1V 4G5, Canada

Prince Charles Hospital- Lung Transplant, Thoraic Dept., Chermside, Queensland 4032, Australia

Royal Adelaide Hospital-Respiratory Clinical Trilas Unit, Adelaide, South Australia 5000, Australia

Vanderbilt Medical Center- IPF Center, Nashville, Tennessee 37232, United States

University of Texas-Southwestern Dallas-Div of Pulm & Critical Care Unit, Dallas, Texas 75390, United States

Baylor College of Medicine, Houston, Texas 77030, United States

University of Utah, Salt Lake City, Utah 84108, United States

Vermont Lung Center, Colchester, Vermont 05446, United States

Inova Heart and Vascular Institute, Falls Church, Virginia 22042, United States

University of Washington Medical Center, Seattle, Washington 98195, United States

St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine, Perth, Western Australia 6000, Australia

University of Wisconsin-Madison, Madison, Wisconsin 53792-3240, United States

Starting date: March 2008
Last updated: May 21, 2008