Back to resultsOpen Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443 (BUILD OL)
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bosentan
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Actelion, Idiopathic Pulmonary Fibrosis, bosentan, Tracleer, Interstitial Lung Disease, BUILD 3 (NCT00391443)
Eligibility 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.
Sites / Locations
- UAB Division of Pulmonary
- Mayo Clinic
- UCLA- Division of Pulmonary & Critcal Care
- UCSD Medical Center
- USCF-Interstitial Lung Disease Center
- Pulmoary and Critical Care Medicine-Stanford University Medical Center
- National Jewish Medical & Research Center
- Yale University School of Medicine
- Emory University
- University of Chicago
- Wichita Clinic, P.A.
- Beth Israel Deaconness Medical Center
- University of Cinicinnati
- The Cleveland Clinic Foundation
- University of Pennsylvania Medical Center
- Vanderbilt Medical Center- IPF Center
- University of Texas-Southwestern Dallas-Div of Pulm & Critical Care Unit
- Baylor College of Medicine
- University of Utah
- Inova Heart and Vascular Institute
- University of Washington Medical Center
- University of Wisconsin-Madison
- St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine
- Prince Charles Hospital- Lung Transplant, Thoraic Dept.
- UZ Gasthuisberg
- Walter C. Mackenzie Health Sciences Centre-University of Alberta
- The Health Care Corporation of St. John's-Eastern Health
- Lawson Health Research Institute
- Toronto General Hospital-Rosedale Medical Center PFT Lab
- Institut de Cardiologie et de Pneumologie de l'Universite Laval
- University Hospital Na Bulovce
- Hopital Avicenne
- Hopital Louis Pradel
- HYLAB, Clinique du Mail
- HELIOS Klinikum Emil von Behring
- Fachkrankenhaus Coswig; Centre for Pumonology and Thoracic Surgery
- Klinik Donaustauf-Zentrum für Pneumologie
- Ruhrlandklinik Pneumologie/Allergologie
- Justus-Liebig-Universitat Giessen-Zentrum für Innere Medizin
- Lungenfachklinik Immenhausen; Pneumologische Lehrklinik der Universität Göttingen
- SKlinikum der Universität München Medizinische Klinik und Poliklinik 1 - Grosshadern
- Mater Misicordiae University Hospital
- Hadassah medical Centrte: Ein Karem-Institue of Pulmonology
- Tel-Aviv Sourasky Medical Centre-Institute of Pulmonary & Allergy Diseases
- Sheba Medical Centre-Pulmonology Institute
- Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento
- Pneumologia ISMETT
- Himeji medical center
- Kanagawa Cardiovascular Respiratory Center
- Asan Medical Center
- Hospital Clinic Barcelona (Pneumology Service)
- Hospital Universitario Ramon y Cajal
- Hospital Clinico San Carlos
- Hospital General de Valencia
- University Hospital Basel-Div of Pneumology
- Inselspital Bern-Div of Pulmonary Medicine
- University Hospital Zurich-Clinic for Pneumology & Lung Transplant Program
- Aberdeen Royal Infirmary
- Southmead Hospital
- Papworth Hospital
- Wythenshawe Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
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
Outcomes
Primary Outcome Measures
Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Mean extent of exposure to bosentan treatment in months
Secondary Outcome Measures
Number of Patients Exposed to Bosentan Over Time
Numbers of participants exposed to bosentan treatment over time
Adverse Events (AE) Leading to Discontinuation of Study Drug.
Number of participants with at least one AE that led to permanent discontinuation of study treatment.
Treatment-emergent Serious Adverse Events (SAE)
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.
Number of participants with an increase in ALT and/or AST to > 3 times upper limit of normal during the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00631475
Brief Title
Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443
Acronym
BUILD OL
Official Title
Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Actelion, Idiopathic Pulmonary Fibrosis, bosentan, Tracleer, Interstitial Lung Disease, BUILD 3 (NCT00391443)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Bosentan
Other Intervention Name(s)
Tracleer
Intervention Description
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.)
Primary Outcome Measure Information:
Title
Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Description
Mean extent of exposure to bosentan treatment in months
Time Frame
Start of study to end of study, up to 21 months
Secondary Outcome Measure Information:
Title
Number of Patients Exposed to Bosentan Over Time
Description
Numbers of participants exposed to bosentan treatment over time
Time Frame
Start to end of study, up to 21 months
Title
Adverse Events (AE) Leading to Discontinuation of Study Drug.
Description
Number of participants with at least one AE that led to permanent discontinuation of study treatment.
Time Frame
Start to end of study, up to 21 months
Title
Treatment-emergent Serious Adverse Events (SAE)
Description
Number of participants with at least one SAE during the study.
Time Frame
up to 21 months plus 28 days after the end of study drug
Title
Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.
Description
Number of participants with an increase in ALT and/or AST to > 3 times upper limit of normal during the study.
Time Frame
up to 21 months, plus 24 hours after the end of study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Leconte
Organizational Affiliation
Actelion
Official's Role
Study Chair
Facility Information:
Facility Name
UAB Division of Pulmonary
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
UCLA- Division of Pulmonary & Critcal Care
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
USCF-Interstitial Lung Disease Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Pulmoary and Critical Care Medicine-Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
National Jewish Medical & Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Wichita Clinic, P.A.
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Beth Israel Deaconness Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Cinicinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt Medical Center- IPF Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas-Southwestern Dallas-Div of Pulm & Critical Care Unit
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Inova Heart and Vascular Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-3240
Country
United States
Facility Name
St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Prince Charles Hospital- Lung Transplant, Thoraic Dept.
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Walter C. Mackenzie Health Sciences Centre-University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
The Health Care Corporation of St. John's-Eastern Health
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Toronto General Hospital-Rosedale Medical Center PFT Lab
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4X 1W4
Country
Canada
Facility Name
Institut de Cardiologie et de Pneumologie de l'Universite Laval
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
University Hospital Na Bulovce
City
Praha 8
ZIP/Postal Code
180 81
Country
Czech Republic
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Hopital Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
HYLAB, Clinique du Mail
City
Grenoble
ZIP/Postal Code
38100
Country
France
Facility Name
HELIOS Klinikum Emil von Behring
City
Berlin
ZIP/Postal Code
D-14165
Country
Germany
Facility Name
Fachkrankenhaus Coswig; Centre for Pumonology and Thoracic Surgery
City
Coswig
Country
Germany
Facility Name
Klinik Donaustauf-Zentrum für Pneumologie
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
Facility Name
Ruhrlandklinik Pneumologie/Allergologie
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Justus-Liebig-Universitat Giessen-Zentrum für Innere Medizin
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Lungenfachklinik Immenhausen; Pneumologische Lehrklinik der Universität Göttingen
City
Immenhausen
Country
Germany
Facility Name
SKlinikum der Universität München Medizinische Klinik und Poliklinik 1 - Grosshadern
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Mater Misicordiae University Hospital
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Hadassah medical Centrte: Ein Karem-Institue of Pulmonology
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Centre-Institute of Pulmonary & Allergy Diseases
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Sheba Medical Centre-Pulmonology Institute
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento
City
Forli
ZIP/Postal Code
47100
Country
Italy
Facility Name
Pneumologia ISMETT
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Himeji medical center
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-8520
Country
Japan
Facility Name
Kanagawa Cardiovascular Respiratory Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Hospital Clinic Barcelona (Pneumology Service)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital General de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
University Hospital Basel-Div of Pneumology
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital Bern-Div of Pulmonary Medicine
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
University Hospital Zurich-Clinic for Pneumology & Lung Transplant Program
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB252ZN
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
ZIP/Postal Code
BS105NB
Country
United Kingdom
Facility Name
Papworth Hospital
City
Cambridgeshire
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443
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