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 |
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.
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.
We found this trial at
40
sites
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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
Boston, Massachusetts 02118
(617) 638-5300
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Boston University School of Medicine A leader in medical education and research, Boston University School...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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University of Utah Research is a major component in the life of the U benefiting...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
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Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Chicago, Illinois 60637
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Darlinghurst, New South Wales 2010
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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New Haven, Connecticut 06520
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Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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