Status:
COMPLETED
BUILD 3: Bosentan Use in Interstitial Lung Disease
Lead Sponsor:
Actelion
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 demonstrat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
616 Patients enrolled
Trial Details
Trial ID
NCT00391443
Start Date
February 1 2007
End Date
July 1 2010
Last Update
February 4 2025
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