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BUILD 3: Bosentan Use in Interstitial Lung Disease (BUILD 3)

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ClinicalTrials.gov Identifier: NCT00391443
Recruitment Status : Completed
First Posted : October 24, 2006
Results First Posted : May 25, 2012
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Description
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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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Bosentan Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 616 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Study Start Date : February 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Bosentan

Arms and Interventions
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Arm Intervention/treatment
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)
 Drug: 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)
Other Names:
  • Ro 47-0203
  • ACT-050088
Placebo Comparator: Placebo
Subjects receive placebo matching the bosentan treatment regimen
 Drug: Placebo
Placebo matching bosentan 62.5 mg tablets and 125 mg tablets


Outcome Measures
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Primary Outcome Measures :
  1. Time to Occurrence of Disease Worsening or Death up to End of Study. [ Time Frame: 36 months ]
    Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).


Secondary Outcome Measures :
  1. Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year. [ Time Frame: 12 months ]
    Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391443


Locations
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Sponsors and Collaborators
Actelion
Investigators
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Study Director: Isabelle Leconte Actelion
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00391443    
Other Study ID Numbers: AC-052-321
First Posted: October 24, 2006    Key Record Dates
Results First Posted: May 25, 2012
Last Update Posted: September 28, 2015
Last Verified: August 2015
Keywords provided by Actelion:
BUILD 3
Idiopathic Pulmonary Fibrosis
Tracleer
 Interstitial Lung Disease
bosentan
Actelion
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
 Respiratory Tract Diseases
Bosentan
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action