EUCTR2015-000392-28-DK进行中（未招募）1 期
A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 750
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
- •- Age >= 18 years
- •- 2013 ACR / EULAR classification criteria for SSc fulfilled
- •- SSc disease onset (defined by first non-Raynaud symptom) within 5 years
- •- SSc related Interstitial Lung Disease confirmed by HRCT; Extent of fibrotic disease in the lung >= 10%
- •- FVC >= 40% of predicted normal
- •- DLCO 30% to 89% of predicted normal
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •- AST, ALT >1.5 x ULN
- •- Bilirubin >1.5 x ULN
- •- Creatinine clearance <30 mL/min
- •- Airway obstruction (pre-bronchodilator FEV1/FVC <0.7)
- •- Other clinically significant pulmonary abnormalities
- •- Significant pulmonary hypertension
- •- Cardiovascular diseases
- •- More than 3 digital fingertip ulcers
- •- Bleeding risk (such as predisposition to bleeding, fibrinolysis, full-dose anticoagulation, high dose antiplatelet therapy, history of hemorrhagic central nervous system (CNS) event within last year
- •- international normalised ratio (INR) >2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x ULN)
- •- History of thrombotic event within last year
- •- Clinical signs of malabsorption or needing parenteral nutrition
- •- Previous treatment with nintedanib or pirfenidone
- •- Treatment with prednisone >10 mg/day, azathioprine, hydroxychloroquine, colchizine, D-penicillamine, sulfasalazine, cyclophosphamide, rituximab, tocilizumab, abatacept, leflunomide, tacrolimus, newer anti-arthritic treatments like tofacitinib and ciclosporine A, potassium para-aminobenzoate
- •- Unstable background therapy with either mycophenolate mofetil or methotrexate
- •- Previous or planned hematopoietic stem cell transplantation
- •- Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic
- •impairment)
- •- Patients with a history of Scleroderma Renal Crisis
研究者
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