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

Phase 3

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Bosentan

Registration Number: NCT00631475

Lead Sponsor: Actelion

Brief 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 128

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Bosentan	For patients who were administered bosentan during BUILD 3 (NCT00391443): Same dose will continue For patients who were administered placebo during BUILD 3 (NCT00391443): Initial dose: 62.5 mg for 4 weeks Maintenance dose: 125 mg

Primary Outcome Measures

Name	Time	Method
Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)	Start of study to end of study, up to 21 months	Mean extent of exposure to bosentan treatment in months

Secondary Outcome Measures

Name	Time	Method
Number of Patients Exposed to Bosentan Over Time	Start to end of study, up to 21 months	Numbers of participants exposed to bosentan treatment over time
Adverse Events (AE) Leading to Discontinuation of Study Drug.	Start to end of study, up to 21 months	Number of participants with at least one AE that led to permanent discontinuation of study treatment.
Treatment-emergent Serious Adverse Events (SAE)	up to 21 months plus 28 days after the end of study drug	Number of participants with at least one SAE during the study.
Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.	up to 21 months, plus 24 hours after the end of study treatment	Number of participants with an increase in ALT and/or AST to \> 3 times upper limit of normal during the study.

Trial Locations

Locations (61): USCF-Interstitial Lung Disease Center
🇺🇸
San Francisco, California, United States
UAB Division of Pulmonary
🇺🇸
Birmingham, Alabama, United States
Pulmoary and Critical Care Medicine-Stanford University Medical Center
🇺🇸
Stanford, California, United States
University of Texas-Southwestern Dallas-Div of Pulm & Critical Care Unit
🇺🇸
Dallas, Texas, United States
St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine
🇦🇺
Darlinghurst, New South Wales, Australia
Hadassah medical Centrte: Ein Karem-Institue of Pulmonology
🇮🇱
Jerusalem, Israel
Wichita Clinic, P.A.
🇺🇸
Wichita, Kansas, United States
National Jewish Medical & Research Center
🇺🇸
Denver, Colorado, United States
Klinik Donaustauf-Zentrum für Pneumologie
🇩🇪
Donaustauf, Germany
Justus-Liebig-Universitat Giessen-Zentrum für Innere Medizin
🇩🇪
Giessen, Germany
Sheba Medical Centre-Pulmonology Institute
🇮🇱
Tel-Hashomer, Israel
University Hospital Na Bulovce
🇨🇿
Praha 8, Czech Republic
University of Wisconsin-Madison
🇺🇸
Madison, Wisconsin, United States
The Health Care Corporation of St. John's-Eastern Health
🇨🇦
St. John's, Newfoundland and Labrador, Canada
Beth Israel Deaconness Medical Center
🇺🇸
Boston, Massachusetts, United States
Hopital Louis Pradel
🇫🇷
Bron, France
Baylor College of Medicine
🇺🇸
Houston, Texas, United States
Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento
🇮🇹
Forli, Italy
University Hospital Zurich-Clinic for Pneumology & Lung Transplant Program
🇨🇭
Zurich, Switzerland
Asan Medical Center
🇰🇷
Seoul, Korea, Republic of
Mayo Clinic
🇺🇸
Scottsdale, Arizona, United States
University of Utah
🇺🇸
Salt Lake City, Utah, United States
University Hospital Basel-Div of Pneumology
🇨🇭
Basel, Switzerland
Ruhrlandklinik Pneumologie/Allergologie
🇩🇪
Essen, Germany
Inselspital Bern-Div of Pulmonary Medicine
🇨🇭
Bern, Switzerland
Hopital Avicenne
🇫🇷
Bobigny, France
HYLAB, Clinique du Mail
🇫🇷
Grenoble, France
Pneumologia ISMETT
🇮🇹
Palermo, Italy
Himeji medical center
🇯🇵
Himeji, Hyogo, Japan
UCLA- Division of Pulmonary & Critcal Care
🇺🇸
Los Angeles, California, United States
UCSD Medical Center
🇺🇸
San Diego, California, United States
Yale University School of Medicine
🇺🇸
New Haven, Connecticut, United States
The Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Vanderbilt Medical Center- IPF Center
🇺🇸
Nashville, Tennessee, United States
University of Cinicinnati
🇺🇸
Cincinnati, Ohio, United States
University of Pennsylvania Medical Center
🇺🇸
Philadelphia, Pennsylvania, United States
Inova Heart and Vascular Institute
🇺🇸
Falls Church, Virginia, United States
Prince Charles Hospital- Lung Transplant, Thoraic Dept.
🇦🇺
Chermside, Queensland, Australia
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States
Walter C. Mackenzie Health Sciences Centre-University of Alberta
🇨🇦
Edmonton, Alberta, Canada
Lawson Health Research Institute
🇨🇦
London, Ontario, Canada
UZ Gasthuisberg
🇧🇪
Leuven, Belgium
Toronto General Hospital-Rosedale Medical Center PFT Lab
🇨🇦
Toronto, Ontario, Canada
Institut de Cardiologie et de Pneumologie de l'Universite Laval
🇨🇦
Ste-Foy, Quebec, Canada
HELIOS Klinikum Emil von Behring
🇩🇪
Berlin, Germany
Fachkrankenhaus Coswig; Centre for Pumonology and Thoracic Surgery
🇩🇪
Coswig, Germany
Lungenfachklinik Immenhausen; Pneumologische Lehrklinik der Universität Göttingen
🇩🇪
Immenhausen, Germany
Mater Misicordiae University Hospital
🇮🇪
Dublin, Ireland
Hospital Universitario Ramon y Cajal
🇪🇸
Madrid, Spain
SKlinikum der Universität München Medizinische Klinik und Poliklinik 1 - Grosshadern
🇩🇪
Munich, Germany
Tel-Aviv Sourasky Medical Centre-Institute of Pulmonary & Allergy Diseases
🇮🇱
Tel-Aviv, Israel
Papworth Hospital
🇬🇧
Cambridgeshire, United Kingdom
Aberdeen Royal Infirmary
🇬🇧
Aberdeen, United Kingdom
Southmead Hospital
🇬🇧
Bristol, United Kingdom
Hospital Clinico San Carlos
🇪🇸
Madrid, Spain
Hospital General de Valencia
🇪🇸
Valencia, Spain
Hospital Clinic Barcelona (Pneumology Service)
🇪🇸
Barcelona, Spain
Kanagawa Cardiovascular Respiratory Center
🇯🇵
Yokohama, Kanagawa, Japan
Wythenshawe Hospital
🇬🇧
Manchester, United Kingdom
Emory University
🇺🇸
Atlanta, Georgia, United States
University of Chicago
🇺🇸
Chicago, Illinois, United States