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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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. - Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year. - Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).
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
Gender
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
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,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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Alabama
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Arizona
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California
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Graz
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Milan
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Padova
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Palermo
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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/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
Other publications