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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Respiratory 0 0 0 0
Other respiratory disorders / diseases

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) - Mean extent of exposure to bosentan treatment in months
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 - Numbers of participants exposed to bosentan treatment 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. - Number of participants with at least one AE that led to permanent discontinuation of study treatment.
Timepoint [2] 0 0
Start to end of study, up to 21 months
Secondary outcome [3] 0 0
Treatment-emergent Serious Adverse Events (SAE) - Number of participants with at least one SAE during the study.
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. - Number of participants with an increase in ALT and/or AST to > 3 times upper limit of normal during the study.
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
Gender
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Belgium
State/province [18] 0 0
Leuven
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
Newfoundland and Labrador
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Praha 8
Country [24] 0 0
France
State/province [24] 0 0
Bobigny
Country [25] 0 0
France
State/province [25] 0 0
Bron
Country [26] 0 0
France
State/province [26] 0 0
Grenoble
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Coswig
Country [29] 0 0
Germany
State/province [29] 0 0
Donaustauf
Country [30] 0 0
Germany
State/province [30] 0 0
Essen
Country [31] 0 0
Germany
State/province [31] 0 0
Giessen
Country [32] 0 0
Germany
State/province [32] 0 0
Immenhausen
Country [33] 0 0
Germany
State/province [33] 0 0
Munich
Country [34] 0 0
Ireland
State/province [34] 0 0
Dublin
Country [35] 0 0
Israel
State/province [35] 0 0
Jerusalem
Country [36] 0 0
Israel
State/province [36] 0 0
Tel-Aviv
Country [37] 0 0
Israel
State/province [37] 0 0
Tel-Hashomer
Country [38] 0 0
Italy
State/province [38] 0 0
Forli
Country [39] 0 0
Italy
State/province [39] 0 0
Palermo
Country [40] 0 0
Japan
State/province [40] 0 0
Hyogo
Country [41] 0 0
Japan
State/province [41] 0 0
Kanagawa
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seoul
Country [43] 0 0
Spain
State/province [43] 0 0
Barcelona
Country [44] 0 0
Spain
State/province [44] 0 0
Madrid
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Spain
State/province [45] 0 0
Valencia
Country [46] 0 0
Switzerland
State/province [46] 0 0
Basel
Country [47] 0 0
Switzerland
State/province [47] 0 0
Bern
Country [48] 0 0
Switzerland
State/province [48] 0 0
Zurich
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Aberdeen
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Bristol
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Cambridgeshire
Country [52] 0 0
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
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).
Trial website
https://clinicaltrials.gov/show/NCT00631475
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

Summary results
Other publications