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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00631475
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : August 3, 2012
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Description
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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).

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Bosentan Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)
Study Start Date : April 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Bosentan

Arms and Interventions
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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 Name: Tracleer


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631475


Locations
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Sponsors and Collaborators
Actelion
Investigators
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Study Chair: Isabelle Leconte Actelion
More Information
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00631475    
Other Study ID Numbers: AC-052-322
First Posted: March 7, 2008    Key Record Dates
Results First Posted: August 3, 2012
Last Update Posted: September 28, 2015
Last Verified: March 2015
Keywords provided by Actelion:
Actelion
Idiopathic Pulmonary Fibrosis
bosentan
 Tracleer
Interstitial Lung Disease
BUILD 3 (NCT00391443)
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
 Respiratory Tract Diseases
Bosentan
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action