EUCTR2018-001747-31-FR进行中（未招募）1 期
A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Tranplant (LTx) recipients with bronchiolitis obliterans sydrome (BOS) grade 1-2 - INFINITX BOS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •1) - Written informed consent signed prior to entry into the trial
- •2) - Patients > ou = à18 years of age when signing his/her informed consent
- •3) - Patients at least at 6 months post-LTx
- •4) - Single- or double-LTx or combined cardio-pulmonary LTx are elligible.
- •5) - Patients must have diagnosis of BOS defined as a decrement of 20% or more in forced expiratory volume in 1 seconde (FEV1) compared to post-transplant baseline FEV1 individualized for each patient according to ISHLT definition [9]. The documented post-LTx baseline value of FEV1 is defined as the mean of the 2 highest values measured at least 3 weeks apart according to ISHLT criteria, and post-LTx VC measurements [9].
- •6) - Patients must have BOS grade 1 or 2 [9]
- •7) - Patients must have documented progressive BOS as demonstrated by the following criteria: at least 3 FEV1 and VC measurements in the last 12 months prior V1, each at least 3 weeks apart, with a total decline of at least 200ml in FEV1 in these last 12 months AND FEV1/VC<0.7 [3]
- •8) - Azithromycin therapy for at least 4 weeks prior to V1, with an Azithromycin dose of minimum 250 mg/day at least 3 times per week as this is considered standard therapy for bronchiolitis obliterans syndrome [16] [34].
- •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 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •- Patients with lung redo transplantation (combined lung transplantation, included heart-lung transplantation are permitted)
- •- Criteria of restrictive allograft syndrome (RAS) at V0, including the following: (1) Decline of VC > 10% of best post-LTx value (FVCBest is defined as the average of the two FVCs associated with the two PFTs used in FEV1 baseline calculation for CLAD diagnosis) AND FEV1/VC > 0.7 AND (2) Thorax HRCT at entry demonstrate new significant findings which are compatible with RAS like interstitial fibrosis, consolidation, appearances suggesting Restrictive Allograft Syndrome (RAS) [3].
- •- FEV1 and/or FV and/or TLC decline related to other nonCLAD causes (eg Diaphragm dysfunction, pneumothorax or pleural effusion, evolutive bronchial stricture within the previous 3 months)
- •- At V0, patients who already have developed severe BOS grade 3
- •- Patients with severe comorbidity complicating CLAD which might determine the prognosis and functional level of the patient (e.g. evolutive invasive aspergillosis or mycobacterial infection within the last 3 months, active malignant disease within the last 12 months).
- •- At visit V1 , diagnosis of documented acute cellular (AR) perivascular rejection higher than grade A1 within the 4 prior weeks OR diagnosis of acute antibody-mediated rejection within the 4 prior weeks, based on presence of all 4 following criteria: 1) acute lung allograft dysfunction, 2) detection of donor-specific antibodies, 3) histological findings compatible with AMR on transbronchial lung biopsy TBBx, and 4) detection of C4d > 50% on TBBx [35] [36].
- •- At visit V1 (end of screening period), diagnosis of documented acute pulmonary infection within the 2 prior weeks, on the basis of the following: 1) clinical, radiological and physiological deterioration; 2) isolation of an organism from a clinically relevant BAL fluid culture; 3) antibiotic therapy resulting in a full recovery and return to pre-morbid lung function.
- •- Previous treatment with Nintedanib after the date of lung transplantation (Treatment with Nintedanib before lung transplantation is not an exclusion criteria).
- •-Within the 2 weeks prior to V1, renal insufficiency with following criteria: Creatinine clearance <30 ml/min estimated by the Cockcroft-Gault equation.
- •-Within the 2 weeks prior to V1, any of the following liver test criteria above the specified limit: Total bilirubin > 1.5 above the upper limit of the normal range (ULN), except in patients with predominantly unconjugated hyperbilirubinemia (e.g., Gilbert's syndrome). Aspartate or alanine aminotransferase (AST or ALT) >3 × ULN
- •- Cardiac disease: (1) History of myocardial infarction within 6 months of visit 1 or unstable angina within 6 months of visit 1; (2) Presence of aortic stenosis (AS) per investigator judgement at visit 1; (3) Severe chronic heart failure: defined by left ventricular ejection fraction (EF) < 25% per investigator judgement at visit 1;
- •- Bleeding Risk: Known genetic predisposition to bleeding; Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin, etc.) or high dose antiplatelet therapy (acetyl salicylic acid >325 mg/day, or clopidogrel >75 mg/day) [NB: Prophylactic low dose hepa
研究者
相似试验
进行中（未招募）
不适用
A Multicenter, Randomized, Double-Blind Trial Of A Novel CCR5 Antagonist, UK-427,857, In Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone For The Treatment of Antiretroviral-Experienced Non CCR5-Tropic HIV-1 Infected SubjectEUCTR2004-001779-20-ITPfizer LTD, Pfizer Global RD-Sandwich Laboratories-I.P.C. 582192
已完成
3 期
A phase III study of ONO-4538(ONO-4538-52/TASUKI-52)JPRN-jRCT2080223505ONO PHARMACEUTICAL CO.,LTD.530
未知
3 期
A Double-Blind, Randomized, Multicentre Trial Comparing the Efficacy and Tolerability of 250mg of Faslodex (Long Acting ICI 182,780) With 20mg of Nolvadex (Tamoxifen) in Postmenopausal Women With Advanced Breast CancerBreast Cancer MetastasisJPRN-jRCT2080220407AstraZeneca
未知
3 期
A Randomized, Double-blinded, Multicenter Study of Denosumab Compared With Zoledronic acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Breast CancerAdvanced breast cancer with bone metastasesJPRN-jRCT2080220875DAIICHISANKYO Co.,Ltd.1,960
招募中
不适用
Double-blind Randomized Multi-center Trial Regarding the Effects of Solution for Gemcitabine on Frequency and Degree of Vascular Pain in Patients with CancerJPRN-UMIN000001827Tohoku University Translational Research Center90