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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
28/09/2015

Titles & IDs
Public title
Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443
Scientific title
Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)
Secondary ID [1] 0 0
AC-052-322
Universal Trial Number (UTN)
Trial acronym
BUILD OL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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.)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Timepoint [1] 0 0
Start of study to end of study, up to 21 months
Secondary outcome [1] 0 0
Number of Patients Exposed to Bosentan Over Time
Timepoint [1] 0 0
Start to end of study, up to 21 months
Secondary outcome [2] 0 0
Adverse Events (AE) Leading to Discontinuation of Study Drug.
Timepoint [2] 0 0
Start to end of study, up to 21 months
Secondary outcome [3] 0 0
Treatment-emergent Serious Adverse Events (SAE)
Timepoint [3] 0 0
up to 21 months plus 28 days after the end of study drug
Secondary outcome [4] 0 0
Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.
Timepoint [4] 0 0
up to 21 months, plus 24 hours after the end of study treatment

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2010
Sample size
Target
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine - Darlinghurst
Recruitment hospital [2] 0 0
Prince Charles Hospital- Lung Transplant, Thoraic Dept. - Chermside
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
State/province [3] 0 0
California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Kansas
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United States of America
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Massachusetts
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Ohio
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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Utah
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Virginia
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Washington
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United States of America
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Wisconsin
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Belgium
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Leuven
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Canada
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Alberta
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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Czech Republic
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Praha 8
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France
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Bobigny
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France
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Bron
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France
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Grenoble
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Germany
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Berlin
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Germany
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Coswig
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Germany
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Donaustauf
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Germany
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Essen
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Germany
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Giessen
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Germany
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Immenhausen
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Germany
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Munich
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Ireland
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Dublin
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Israel
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Jerusalem
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Israel
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Tel-Aviv
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Israel
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Tel-Hashomer
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Italy
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Forli
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Italy
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Palermo
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Japan
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Hyogo
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Japan
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Kanagawa
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Korea, Republic of
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Seoul
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Zurich
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United Kingdom
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Aberdeen
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United Kingdom
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Bristol
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United Kingdom
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Cambridgeshire
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United Kingdom
State/province [52] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Actelion
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Isabelle Leconte
Address 0 0
Actelion
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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