EUCTR2008-006054-17-DE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
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 of at least 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 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: FVC < 50% predicted (at both Visit 1 and Visit 2), or FVC < 1.2 liter.
- •5. Corrected diffusing capacity of the lung for carbon monoxide (corrected DLCO)
- •< 30% predicted (at both Visit 1 and Visit 2).
- •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. The assessment of
- •sustained improvement will be left to the investigator’s judgment.
- •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 [PFTs]).
- •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 (see Appendix 2 for the calculation of
- •the estimated creatinine clearance).
- •14. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)
- •> 1.5 × ULN.
- •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, interferon ?,
- •Chronic use of N-acetylcysteine > 600 mg/day (prescribed for IPF).
- •Oral anticoagulants prescribed for IPF.
- •20. Treatment with ERAs within 4 weeks prior to randomization.
- •21. Systemic treatment within 4 weeks prior to randomization with cyclosporine A or
- •tacrolimus, everolimus, sirolimus (calcineurin or mammalian target of rapamycin
- •[mTOR] inhibitors).
- •22. Treatment with CYP3A inducers within 4 weeks prior to randomization.
- •23. Known hypersensitivity to drugs of the same class as the study drug, or any of their excipients.
- •24. Planned treatment, or treatment, with another investigational drug within 4 weeks prior to randomization.
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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 - MUSICTo evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis.MedDRA version: 9.1Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosisEUCTR2008-006054-17-SIActelion Pharmaceuticals Ltd.156