EUCTR2006-001183-24-GB进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •*Signed informed consent.
- •*Male or female patients 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 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
排除标准
- •*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.
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