A multinational, open-label, randomised, controlled trial to investigate efficacy and safety of NNC0365-3769 (Mim8) in adults and adolescents with haemophilia A with or without inhibitors. - FRONTIER 2

OVO NORDISK. S.P.A.0 个研究点目标入组 230 人开始时间: 2021年6月7日最近更新: 2021年8月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 230

研究概览入排标准研究者记录与标识符相似试验

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

•- Informed consent obtained before any trial-related activities. Trialrelated activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
•- Male or female with diagnosis of congenital haemophilia A of any severity based on medical records
•- Patient has been prescribed, or in need of, treatment with factor VIII or bypassing agent in the last 26 weeks prior to screening
•- Age above or equal to 12 years at the time of signing informed consent.
•- Body weight above or equal to 30 kg
•- Applicable to patients on emicizumab prophylaxis: patient is willing to discontinue emicizumab at the time of screening
•- Applicable to patients treated with no prophylaxis prior to enrolment: 5 or more bleeds in the last 26 weeks prior to screening visit
•- Applicable to patients with FVIII activity above 1% who are on prophylactic treatment: 1 or more bleeds in the last 26 weeks prior to screening visit
•- Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires
•Are the trial subjects under 18? yes
•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 190
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

排除标准

•- Previous participation in this trial. Participation is defined as signed informed consent
•- Participation in any clinical trial of an approved or non-approved investigational medicinal product, within 30 days (or 5 half-lives of the investigational medicinal product, whichever is greater) before screening
•- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (highly effective contraceptive measures as defined in the protocol or as required by local regulation or practice). Breast feeding is allowed only during the run-in period
•- Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
•- Known or suspected hypersensitivity to trial product(s), any constituents of the product or to related products
•- Receipt of gene therapy at any given time point
•- Ongoing or planned immune tolerance induction (ITI) therapy
•- Major surgery planned at the time of screening
•- Known congenital or acquired coagulation disorders other than haemophilia A
•- Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit combined with total bilirubin above 1.5 times the upper limit measured at screening
•- Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below or equal to 30 ml/min/1.73 m^2 for serum creatinine measured at screening
•- Previous or current thromboembolic disease or events (includes arterial and venous thrombosis including myocardial infarction, thrombotic
•microangiography (TMA), pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events and peripheral artery occlusion) (with the exception of previous catheter-associated thrombosis for which antithrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator
•- Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
•- Other conditions (e.g. autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator

研究者

发起方

OVO NORDISK. S.P.A.

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