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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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [45] 0 0
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