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

Information source: Actelion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Pulmonary Fibrosis

Intervention: Bosentan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Actelion

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

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).

Clinical Details

Official title: Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Secondary outcome:

Number of Patients Exposed to Bosentan Over Time

Adverse Events (AE) Leading to Discontinuation of Study Drug.

Treatment-emergent Serious Adverse Events (SAE)

Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.

Eligibility

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 (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 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 (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, 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.

Locations and Contacts

UZ Gasthuisberg, Leuven 3000, Belgium

University Hospital Na Bulovce, Praha 8 180 81, Czech Republic

Hopital Avicenne, Bobigny 93009, France

Hopital Louis Pradel, Bron 69677, France

HYLAB, Clinique du Mail, Grenoble 38100, France

HELIOS Klinikum Emil von Behring, Berlin D-14165, Germany

Fachkrankenhaus Coswig; Centre for Pumonology and Thoracic Surgery, Coswig, Germany

Klinik Donaustauf-Zentrum für Pneumologie, Donaustauf 93093, Germany

Ruhrlandklinik Pneumologie/Allergologie, Essen 45239, Germany

Justus-Liebig-Universitat Giessen-Zentrum für Innere Medizin, Giessen 35392, Germany

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

SKlinikum der Universität München Medizinische Klinik und Poliklinik 1 - Grosshadern, Munich 81377, Germany

Mater Misicordiae University Hospital, Dublin 7, Ireland

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

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

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

Pneumologia ISMETT, Palermo 90127, Italy

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

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

Hospital Clinico San Carlos, Madrid 28040, Spain

Hospital Universitario Ramon y Cajal, Madrid 28034, Spain

Hospital General de Valencia, Valencia 46014, Spain

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

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

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

Aberdeen Royal Infirmary, Aberdeen AB252ZN, United Kingdom

Southmead Hospital, Bristol BS105NB, United Kingdom

Papworth Hospital, Cambridgeshire CB23 3RE, United Kingdom

Wythenshawe Hospital, Manchester M23 9LT, 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

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

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

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

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

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

Emory University, Atlanta, Georgia 30322, United States

Himeji medical center, Himeji, Hyogo 670-8520, Japan

University of Chicago, Chicago, Illinois, United States

Kanagawa Cardiovascular Respiratory Center, Yokohama, Kanagawa 236-0051, Japan

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

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

St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine, Darlinghurst, New South Wales 2010, Australia

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

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

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

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

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

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

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

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

Additional Information

Starting date: April 2008
Last updated: September 27, 2012

Page last updated: August 23, 2015

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