EUCTR2015-003360-37-IT进行中（未招募）1 期
A double blind, randomized, placebo-controlled trial evaluating the efficacyand safety of nintedanib over 52 weeks in patients with ProgressiveFibrosing Interstitial Lung Disease (PF-ILD) - Nintedanib in PF-ILD
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 个研究点目标入组 1,010 人开始时间: 2021年2月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,010
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. Written Informed Consent consistent with ICH-GCP and local laws signed prior to
- •entry into the study (and prior to any study procedure including shipment of HRCT to
- •2. Male or female patients aged = 18 years at Visit 1.
- •3. Patients with physician diagnosed ILD who fulfil at least one of the following criteria
- •for PF-ILD within 24 months of screening visit (Visit 1) despite treatment with
- •unapproved medications used in clinical practice to treat ILD, as assessed by the
- •investigator (refer to Exclusion Criteria):
- •a. Clinically significant decline in FVC % pred based on a relative decline of =10%
- •b. Marginal decline in FVC % pred based on a relative decline of =5-<10%
- •combined with worsening of respiratory symptoms
- •c. Marginal decline in FVC % pred based on a relative decline of =5-<10%
- •combined with increasing extent of fibrotic changes on chest imaging
- •d. Worsening of respiratory symptoms as well as increasing extent of fibrotic
- •changes on chest imaging
- •[Note: Changes attributable to comorbidities e.g. infection, heart failure must be
- •excluded. Unapproved medications used in the clinical practice to treat ILD
- •include but are not limited to corticosteroid, azathioprine, mycophenolate mofetil
- •(MMF), n-acetylcysteine (NAC), rituximab, cyclophosphamide, cyclosporine,
- •tacrolimus].
- •4. Fibrosing lung disease on HRCT, defined as reticular abnormality with traction
- •bronchiectasis with or without honeycombing, with disease extent of >10%, performed
- •within 12 months of Visit 1 as confirmed by central readers.
- •5. For patients with underlying CTD: stable CTD as defined by no initiation of new
- •therapy or withdrawal of therapy for CTD within 6 weeks prior to Visit 1.
- •6. DLCO corrected for Haemoglobin (Hb) [visit 1] = 30% and <80% predicted of normal
- •at Visit 2 (refer to Appendix 10.1).
- •7. FVC = 45% predicted at Visit 2 (refer to Appendix 10.1).
- •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 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1.AST, ALT > 1.5 x ULN at Visit 1
- •2.Bilirubin > 1.5 x ULN at Visit 1
- •3.Creatinine clearance <30 mL/min calculated by Cockcroft–Gault formula at Visit 1
- •4.Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic
- •impairment).
- •5.Previous treatment with nintedanib or pirfenidone.
- •6.Other investigational therapy received within 1 month or 6 half-lives (whichever was
- •greater) prior to screening visit (Visit 1).
- •7.Use of any of the following medications for the treatment of ILD: azathioprine (AZA),
- •cyclosporine, MMF, tacrolimus, oral corticosteroids (OCS) >20mg/day and the
- •combination of OCS+AZA+NAC within 4 weeks of Visit 2, cyclophosphamide within
- •8 weeks of Visit 2, rituximab within 6 months of Visit 2.
- •8.Diagnosis of IPF based on ATS/ERS/JRS/ALAT 2011 Guidelines (P11-07084).
- •9.Significant Pulmonary Arterial Hypertension (PAH) defined by any of the following:
- •a. Previous clinical or echocardiographic evidence of significant right heart failure
- •b. History of right heart catheterization showing a cardiac index = 2 l/min/m²
- •c. PAH requiring parenteral therapy with epoprostenol/treprostinil
- •10.Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC < 0.7 at
- •11.In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
- •12.Major extrapulmonary physiological restriction (e.g. chest wall abnormality, large
- •pleural effusion)
- •13.Cardiovascular diseases, any of the following:
- •a. Severe hypertension, uncontrolled under treatment (=160/100 mmHg), within
- •6 month of Visit 1
- •b. Myocardial infarction within 6 months of Visit 1
- •c. Unstable cardiac angina within 6 months of Visit 1
- •14.Bleeding risk, any of the following:
- •a. Known genetic predisposition to bleeding.
- •b. Patients who require
- •i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists,
- •direct thrombin inhibitors, heparin, hirudin)
- •ii. High dose antiplatelet therapy.
- •[Note: Prophylactic low dose heparin or heparin flush as needed for
- •maintenance of an indwelling intravenous device (e.g. enoxaparin 4000 I.U. s.c.
- •per day), as well as prophylactic use of antiplatelet therapy (e.g. acetyl salicylic
- •acid up to 325 mg/day, or clopidogrel at 75 mg/day, or equivalent doses of other
- •antiplatelet therapy) are not prohibited].
- •c. History of haemorrhagic central nervous system (CNS) event within 12 months of
- •d. Any of the following within 3 months of Visit 1:
- •i. Haemoptysis or haematuria
- •ii. Active gastro-intestinal (GI) bleeding or GI – ulcers
- •iii. Major injury or surgery (Investigators judgment).
- •e. Coagulation parameters: International normalized ratio (INR) >2, prolongation of
- •prothrombin time (PT) and activated partial thromboplastin time (aPTT) by >1.5 x
- •ULN at Visit 1.
- •15.History of thrombotic event (including stroke and transient ischemic attack) within 12
- •months of Visit 1.
- •16.Known hypersensitivity to the trial medication or its components (i.e. soya lecithin)
- •For others criteria, see protocol
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