BUILD 3: Bosentan Use in Interstitial Lung Disease



Status:Completed
Conditions:Pulmonary, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2007
End Date:July 2010

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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.

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.


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)

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.
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San Francisco, California 94143
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201 Dowman Dr
Atlanta, Georgia 30303
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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72 East Concord Street
Boston, Massachusetts 02118
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330 Brookline Ave
Boston, Massachusetts 02215
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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1200 Moursund Street
Houston, Texas 77030
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Minneapolis, Minnesota 55455
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201 Presidents Circle
Salt Lake City, Utah 84108
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University of Utah Research is a major component in the life of the U benefiting...
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Birmingham, Alabama 35294
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Brandon, Florida 33511
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171 Ashley Avenue
Charleston, South Carolina 29425
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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2049 E 100th St
Cleveland, Ohio 44106
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Colchester, Vermont 05446
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Falls Church, Virginia 22042
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Los Angeles, California 90033
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Madison, Wisconsin 53706
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Nashville, Tennessee 37232
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1959 NE Pacific St
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