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

September 9, 2015 updated by: Actelion

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Tracleer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Mean extent of exposure to bosentan treatment in months
Start of study to end of study, up to 21 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Exposed to Bosentan Over Time
Time Frame: Start to end of study, up to 21 months
Numbers of participants exposed to bosentan treatment over time
Start to end of study, up to 21 months
Adverse Events (AE) Leading to Discontinuation of Study Drug.
Time Frame: 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.
Start to end of study, up to 21 months
Treatment-emergent Serious Adverse Events (SAE)
Time Frame: up to 21 months plus 28 days after the end of study drug
Number of participants with at least one SAE during the study.
up to 21 months plus 28 days after the end of study drug
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
Number of participants with an increase in ALT and/or AST to > 3 times upper limit of normal during the study.
up to 21 months, plus 24 hours after the end of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Investigators

  • Study Chair: Isabelle Leconte, Actelion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

February 12, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (ESTIMATE)

March 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 9, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-052-322

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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