EUCTR2019-002593-31-FR进行中（未招募）1 期
Efficacy of Nintedanib per os as a treatment for epistaxis in HHT diseaseA national, randomized, multicenter phase II studyEPICURE
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
- 60
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
- •?Age > 18 years old
- •?Patients who have given their free informed and signed consent
- •?Patients affiliated to a social security scheme or similar
- •?Patients monitored for clinically confirmed HHT and/or with molecular biology confirmation
- •?Patient with an Epistaxis Severity Score (ESS) > 4 (target population of patients with important consequences on quality of life)
- •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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Pregnant woman or woman of child bearing potential not using two effective methods of birth control (one barrier and one highly effective non-barrier) for at least 1 month prior to trial and/or committing to using it until 3 months after the end of treatment.
- •Woman who are breast feeding.
- •Patient who are protected adults under the terms of the law (French Public Health Code).
- •Participation in another interventional clinical trial which may interfere with the proposed trial (judgment of the investigator).
- •Clinical evidence of active infection.
- •(AST, ALT > 1,5 fold upper limit of normal (ULN) and/or Bilirubin > 1,5 fold upper limit of normal (ULN).
- •Severe renal impairment (Creat Clearance <30 mL/min) estimated by the Cockcroft-Gault equation.
- •Presence of non-treated pulmonary arteriovenous malformations accessible to a treatment on CT scan within 5 years.
- •Patients with hemoptysis or hematuria within 12 weeks prior to inclusion.
- •Patients with active gastro-intestinal (GI) bleeding or GI ulcers.
- •Presence of cerebral arteriovenous malformation on MRI done within 5 years prior inclusion.
- •Patients who require full-dose therapeutic anticoagulation (e.g. vitamin K antagonist or heparin, dabigatran) or high dose antiplatelet therapy.
- •Patients with known coronary artery disease or recent history of myocardial infarction (within 1 year).
- •Known inherited predisposition to thrombosis or thrombotic events (including stroke and transient ischemic attack) within 12 months prior to inclusion.
- •Patients with QTc prolongation (on ECG, less than 3 months).
- •Hypersensitivity to nintedanib, peanut or soya, or to any of the excipients.
- •Patient who incompletely filled in epistaxis grids within 8 weeks prior to inclusion.
- •Patient who have received intravenous bevacizumab within 6 months prior to inclusion.
- •Patient who had surgery (including ENT surgery) within 12 weeks prior to inclusion.
- •Unhealed wound.
- •Planned major surgery within the next 3 months, including liver transplantation, major abdominal or intestinal surgery.
研究者
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