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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00631475
First received: February 12, 2008
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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).


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Bosentan
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF) [ Time Frame: Start of study to end of study, up to 21 months ] [ Designated as safety issue: Yes ]
    Mean extent of exposure to bosentan treatment in months


Secondary Outcome Measures:
  • Number of Patients Exposed to Bosentan Over Time [ Time Frame: Start to end of study, up to 21 months ] [ Designated as safety issue: Yes ]
    Numbers of participants exposed to bosentan treatment over time

  • Adverse Events (AE) Leading to Discontinuation of Study Drug. [ Time Frame: Start to end of study, up to 21 months ] [ Designated as safety issue: Yes ]
    Number of participants with at least one AE that led to permanent discontinuation of study treatment.

  • Treatment-emergent Serious Adverse Events (SAE) [ Time Frame: up to 21 months plus 28 days after the end of study drug ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: up to 21 months, plus 24 hours after the end of study treatment ] [ Designated as safety issue: Yes ]
    Number of participants with an increase in ALT and/or AST to > 3 times upper limit of normal during the study.


Enrollment: 128
Study Start Date: April 2008
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

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

Drug: Bosentan

For patients who were administered Bosentan during BUILD 3 (NCT00391443):

continue on same dose

For patients who were administered placebo during BUILD 3 (NCT00391443):

Oral Bosentan 62.5 mg for 4 weeks; maintenance dose: 125 mg ( 62.5 if patient weighs < 90 lbs.)

Other Name: Tracleer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631475

  Hide Study Locations
Locations
United States, Alabama
UAB Division of Pulmonary
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
UCLA- Division of Pulmonary & Critcal Care
Los Angeles, California, United States, 90095
UCSD Medical Center
San Diego, California, United States, 92103
USCF-Interstitial Lung Disease Center
San Francisco, California, United States, 94143
Pulmoary and Critical Care Medicine-Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
National Jewish Medical & Research Center
Denver, Colorado, United States, 80206
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago
Chicago, Illinois, United States
United States, Kansas
Wichita Clinic, P.A.
Wichita, Kansas, United States, 67208
United States, Massachusetts
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States, 02215
United States, Ohio
University of Cinicinnati
Cincinnati, Ohio, United States, 45267
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt Medical Center- IPF Center
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas-Southwestern Dallas-Div of Pulm & Critical Care Unit
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
United States, Virginia
Inova Heart and Vascular Institute
Falls Church, Virginia, United States, 22042
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792-3240
Australia, New South Wales
St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
Prince Charles Hospital- Lung Transplant, Thoraic Dept.
Chermside, Queensland, Australia, 4032
Belgium
UZ Gasthuisberg
Leuven, Belgium, 3000
Canada, Alberta
Walter C. Mackenzie Health Sciences Centre-University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, Newfoundland and Labrador
The Health Care Corporation of St. John's-Eastern Health
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Lawson Health Research Institute
London, Ontario, Canada, N6A 4G5
Toronto General Hospital-Rosedale Medical Center PFT Lab
Toronto, Ontario, Canada, M4X 1W4
Canada, Quebec
Institut de Cardiologie et de Pneumologie de l'Universite Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Czech Republic
University Hospital Na Bulovce
Praha 8, Czech Republic, 180 81
France
Hopital Avicenne
Bobigny, France, 93009
Hopital Louis Pradel
Bron, France, 69677
HYLAB, Clinique du Mail
Grenoble, France, 38100
Germany
HELIOS Klinikum Emil von Behring
Berlin, Germany, D-14165
Fachkrankenhaus Coswig; Centre for Pumonology and Thoracic Surgery
Coswig, Germany
Klinik Donaustauf-Zentrum für Pneumologie
Donaustauf, Germany, 93093
Ruhrlandklinik Pneumologie/Allergologie
Essen, Germany, 45239
Justus-Liebig-Universitat Giessen-Zentrum für Innere Medizin
Giessen, Germany, 35392
Lungenfachklinik Immenhausen; Pneumologische Lehrklinik der Universität Göttingen
Immenhausen, Germany
SKlinikum der Universität München Medizinische Klinik und Poliklinik 1 - Grosshadern
Munich, Germany, 81377
Ireland
Mater Misicordiae University Hospital
Dublin, Ireland, 7
Israel
Hadassah medical Centrte: Ein Karem-Institue of Pulmonology
Jerusalem, Israel, 91120
Tel-Aviv Sourasky Medical Centre-Institute of Pulmonary & Allergy Diseases
Tel-Aviv, Israel, 64239
Sheba Medical Centre-Pulmonology Institute
Tel-Hashomer, Israel, 52621
Italy
Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento
Forli, Italy, 47100
Pneumologia ISMETT
Palermo, Italy, 90127
Japan
Himeji medical center
Himeji, Hyogo, Japan, 670-8520
Kanagawa Cardiovascular Respiratory Center
Yokohama, Kanagawa, Japan, 236-0051
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Spain
Hospital Clinic Barcelona (Pneumology Service)
Barcelona, Spain, 08036
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital General de Valencia
Valencia, Spain, 46014
Switzerland
University Hospital Basel-Div of Pneumology
Basel, Switzerland, 4031
Inselspital Bern-Div of Pulmonary Medicine
Bern, Switzerland, 3010
University Hospital Zurich-Clinic for Pneumology & Lung Transplant Program
Zurich, Switzerland, 8091
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB252ZN
Southmead Hospital
Bristol, United Kingdom, BS105NB
Papworth Hospital
Cambridgeshire, United Kingdom, CB23 3RE
Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Actelion
Investigators
Study Chair: Isabelle Leconte Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00631475     History of Changes
Other Study ID Numbers: AC-052-322
Study First Received: February 12, 2008
Results First Received: June 19, 2012
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Actelion:
bosentan
Tracleer
Actelion
BUILD 3 (NCT00391443)
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014