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

Active, not recruiting

• Conditions: Idiopathic Pulmonary Fibrosis (IPF); MedDRA version: 8.1Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis

• Registration Number: EUCTR2006-001183-24-DE
• Lead Sponsor: ACTELION PHARMACEUTICALS LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-01
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

*Signed informed consent.

*Male or female patients aged 18 years or older

*Women of childbearing potential must have a negative result on their serum pregnancy test at the screening visit and use reliable methods of contraception during study treatment and for 3 months after study treatment termination.
Reliable methods of contraception are:
·Intrauterine devices
·Oral, injectable, transdermal or implantable hormonal contraceptives only in combination with a barrier method (e.g., female condom, diaphragm, contraceptive sponge) or use of a condom by her partner.
-Hormone-based contraceptives alone, regardless of the route of administration, are not considered as reliable methods of contraception.
-Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception.

Women not of childbearing potential are defined as postmenopausal (i.e. amenorrhea for at least 1 year), or surgically or naturally sterile. To assure compliance, the study personnel wil be contacting women of childbearing potential throughout the trial to remind them to use reliable methods of contraception.

*Proven diagnosis of IPF according to ATS/ERS statement, of < 3 years, with surgical lung biopsy (SLB).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

*Interstitial lung disease due to conditions other than IPF.
*Presence of extensive honeycomb (HC) on Baseline high-resolution computed tomography (HRCT) scan. The patient is not allowed in BUILD 3 if HC involves more than 5 % of the parenchyma in 3 or more of the 6 zones (i.e., right and left lung, viewed at the levels of tracheal carina, inferior pulmonary veins, and 1 cm above the dome of the diaphragm), whether the involvement is unilateral or bilateral.
*Severe concomitant illness limiting life expectancy (< 1 year).
*Severe restrictive lung disease: forced vital capacity (FVC) < 50% predicted, or FVC < 1.2 liter.
*Diffusing capacity of the lung for carbon monoxide (DLCO) < 30% predicted.
*Residual volume = 120% predicted.
*Obstructive lung disease: forced expiratory volume in 1 second (FEV1)/FVC < 0.65.
*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 (e.g., pulmonary function tests).
*Chronic heart failure with NYHA class III/IV or known left ventricular ejection fraction < 25%.
*ALT/SGPT and/or AST/SGOT > 1.5 times the upper limit of the normal ranges (ULN).
*Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
*Serum creatinine = 2.5 mg/dl (221 mmol/l) 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 including pirfenidone, D-penicillamine, colchicine, TNFa blocker, imatinib, interferon g, cyclophosphamide, azathioprine,
-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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified