EUCTR2008-006054-17-SI进行中（未招募）不适用
A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 156
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
- 性别
- All
入选标准
- •1. Signed informed consent.
- •2. Male or female patients over 18 years of age (females of child-bearing potential must use a reliable method of contraception).
- •3. IPF diagnosis within 3 years prior to randomization, proven according to ATS/ERS consensus statement, with surgical lung biopsy.
- •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
- •1. Interstitial lung disease due to conditions other than IPF.
- •2. Presence of extensive honeycombing (HC) on Baseline high-resolution computed tomography (HRCT) scan performed within 3 months prior to randomization.
- •The patient is not allowed in the study 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.
- •3. Severe concomitant illness limiting life expectancy (< 1 year).
- •4. Severe restrictive lung disease: forced vital capacity
- •(FVC) < 50% predicted, or FVC < 1.2 liter.
- •5. Diffusing capacity of the lung for carbon monoxide
- •(DLCO) < 30% predicted.
- •6. Residual volume = 120% predicted.
- •7. Obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.70.
- •8. Documented sustained improvement of the patient's IPF condition up to 12 months prior to randomization with or without IPF-specific therapy.
- •9. Recent pulmonary or upper respiratory tract infection (up to 4 weeks prior to randomization).
- •10. Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements (e.g., pulmonary function tests).
- •11. Chronic heart failure with NYHA class III/IV or known left ventricular ejection fraction < 25%.
- •12. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
- •13. Estimated creatinine clearance < 30 mL/min.
- •14. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal.
- •15. Hemoglobin < 75% of the lower limit of the normal range.
- •16. Systolic blood pressure < 100 mmHg.
- •17. Pregnant or breast-feeding.
- •18. Current drug or alcohol dependence.
- •19. Chronic treatment with the following drugs (within 4 weeks of randomization):
- •- Oral corticosteroids (> 20 mg/day of prednisone or equivalent),
- •- Immunosuppressive or cytotoxic drugs including cyclophosphamide and azathioprine,
- •- Antifibrotic drugs including pirfenidone, D-penicillamine, colchicine, TNFa blocker, imatinib and interferon ?,
- •- Chronic use of N-acetylcysteine prescribed for IPF (> 600 mg/day).
- •20. Oral anticoagulants other than those indicated for a venous or
- •arterial thrombotic disease within 4 weeks prior to randomization.
- •21. Treatment with endothelin receptor antagonists (ERAs) within 4 weeks prior to randomization.
- •22. Previous participation in the BUILD-3 (Bosentan Use in Interstitial Lung Disease) study within 6 months prior to randomization.
- •23. Systemic treatment within 4 weeks prior to randomization with cyclosporine A or tacrolimus, everolimus, sirolimus (calcineurin or mTOR inhibitors).
- •24. Treatment with CYP3A inducers within 4 weeks prior to randomization.
- •25. Known hypersensitivity to drugs of the same class as the study drug, or any of their excipients.
- •26. Planned treatment, or treatment, with another investigational drug within 4 weeks prior to randomization.
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