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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00631475
Registration number
NCT00631475
Ethics application status
Date submitted
12/02/2008
Date registered
7/03/2008
Date last updated
4/02/2025
Titles & IDs
Public title
Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443
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Scientific title
Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)
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Secondary ID [1]
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AC-052-322
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Universal Trial Number (UTN)
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Trial acronym
BUILD OL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bosentan
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
Treatment: Drugs: 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.)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
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Assessment method [1]
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Mean extent of exposure to bosentan treatment in months
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Timepoint [1]
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Start of study to end of study, up to 21 months
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Secondary outcome [1]
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Number of Patients Exposed to Bosentan Over Time
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Assessment method [1]
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Numbers of participants exposed to bosentan treatment over time
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Timepoint [1]
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Start to end of study, up to 21 months
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Secondary outcome [2]
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Adverse Events (AE) Leading to Discontinuation of Study Drug.
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Assessment method [2]
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Number of participants with at least one AE that led to permanent discontinuation of study treatment.
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Timepoint [2]
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Start to end of study, up to 21 months
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Secondary outcome [3]
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Treatment-emergent Serious Adverse Events (SAE)
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Assessment method [3]
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Number of participants with at least one SAE during the study.
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Timepoint [3]
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up to 21 months plus 28 days after the end of study drug
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Secondary outcome [4]
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Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.
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Assessment method [4]
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Number of participants with an increase in ALT and/or AST to \> 3 times upper limit of normal during the study.
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Timepoint [4]
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up to 21 months, plus 24 hours after the end of study treatment
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2010
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Sample size
Target
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Accrual to date
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Final
128
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Actelion
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT00631475
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Isabelle Leconte
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Address
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Actelion
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00631475
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