NL-OMON31629已完成3 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 - Bosentan Use in Interstitial Lung Disease BUILD-3
Actelion Pharmaceuticals0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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).
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 *mol/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,TNFalfa blocker, imatinib, interferon *, 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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