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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00391443




Registration number
NCT00391443
Ethics application status
Date submitted
20/10/2006
Date registered
24/10/2006
Date last updated
28/09/2015

Titles & IDs
Public title
BUILD 3: Bosentan Use in Interstitial Lung Disease
Scientific title
Effects of Bosentan on Morbidity and Mortality in Patients With Idiopathic Pulmonary Fibrosis - a Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Group Sequential, Phase III Study.
Secondary ID [1] 0 0
AC-052-321
Universal Trial Number (UTN)
Trial acronym
BUILD 3
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
Treatment: Drugs - Placebo

Experimental: Bosentan - Subjects receive bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg b.i.d (if body weight > 40 kg) or bosentan 62.5 mg b.i.d. (if body weight < 40 kg)

Placebo Comparator: Placebo - Subjects receive placebo matching the bosentan treatment regimen


Treatment: Drugs: Bosentan
Bosentan 62.5 mg tablets twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg tablets b.i.d (if body weight > 40 kg) or bosentan 62.5 mg tablets b.i.d. (if body weight < 40 kg)

Treatment: Drugs: Placebo
Placebo matching bosentan 62.5 mg tablets and 125 mg tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Occurrence of Disease Worsening or Death up to End of Study.
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year.
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
- Signed informed consent

- Male or female aged 18 years or older (females of child-bearing potential must have
been surgically sterilized or use a reliable method of contraception.)

- Proven diagnosis of IPF according to American Thoracic Society / European Respiratory
Society (ATS-ERS) statement, of <3 years, with surgical lung biopsy (SLB)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Interstitial lung disease due to conditions other than IPF.

- Presence of extensive honeycombing (HC) on baseline high-resolution computed
tomography (HRCT) scan.

- Severe concomitant illness limiting life expectancy (<1 year).

- Severe restrictive lung disease.

- Obstructive lung disease.

- Diffusing capacity of the lung for carbon monoxide <30% predicted.

- Residual volume > or = 120% predicted.

- Documented sustained improvement of patient's IPF condition up to 12 months prior to
randomization with or without IPF-specific therapy.

- Recent pulmonary or upper respiratory tract infection (up to 4 weeks prior to
randomization).

- Acute or chronic impairment (other than dyspnea) limiting the ability to comply with
study requirements.

- Chronic heart failure with New York Heart Association (NYHA) class III/IV or known
left ventricular ejection fraction <25%.

- Alanine aminotransferase (ALT/SGPT) and/or aspartate aminotransferase (AST/SGOT) > 1.5
times the upper limit of the normal ranges.

- Moderate to severe hepatic impairment.

- Serum creatinine > or = 2.5 mg/dl or chronic dialysis.

- Hemoglobin concentration <75% the lower limit of the normal ranges.

- Systolic blood pressure <85 mmHg.

- Pregnancy or breast-feeding.

- Current drug or alcohol dependence.

- Chronic treatment with the following drugs prescribed for IPF (within 4 weeks of
randomization):oral corticosteroids (>20 mg/day of prednisone or equivalent),
immunosuppressive or cytotoxic drugs, antifibrotic drugs, chronic use of
N-acetylcysteine (prescribed for IPF).

- Oral anticoagulants other than those indicated for a venous or arterial thrombotic
disease.

- Treatment with glibenclamide (glyburide) and calcineurin inhibitors (cyclosporine A,
tacrolimus) up to 1 week prior to randomization.

- Treatment with an endothelin receptor antagonist up to 3 months prior to
randomization.

- Participation in the BUILD 1 trial.

- Treatment with another investigational drug up to 3 months prior to randomization or
planned treatment.

- Known hypersensitivity to bosentan or any of the excipients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2010
Sample size
Target
Accrual to date
Final
616
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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 hospital [3] 0 0
Royal Adelaide Hospital-Respiratory Clinical Trials Unit - Adelaide
Recruitment hospital [4] 0 0
Royal Perth Hospital; Advanced Lung Disease Unit - Perth
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Kansas
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Massachusetts
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Minnesota
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Missouri
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New Jersey
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New York
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North Carolina
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Utah
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Vermont
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Washington
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Wisconsin
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Austria
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Graz
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Austria
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Grimmenstein
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Innsbruck
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Coswig
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Giessen
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Heidelberg
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Haifa
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Jerusalem
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Israel
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Petach Tikvah
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Israel
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Rehovot
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Israel
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Israel
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Milan
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Italy
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Padova
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Italy
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Palermo
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Siena
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Nara
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Korea, Republic of
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Incheon
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Netherlands
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Serbia
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Belgrade
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Cambridge
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London
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Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group,
placebo-controlled, event-driven, group sequential, phase III superiority study. The primary
objective is to demonstrate that bosentan delays disease worsening or death in patients with
Idiopathic Pulmonary Fibrosis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00391443
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00391443