A multinational, open-label, randomised, controlled study to investigate efficacy and safety of NNC0365-3769 (Mim8) in adults and adolescents with haemophilia A with or without inhibitors(NN7769-4514) - Frontier 2

Esaki Risa0 个研究点目标入组 272 人开始时间: 2022年3月3日最近更新: 2024年4月1日

适应症

试验速览

暂无简介。

•Male or female with diagnosis of congenital haemophilia A of any severity based on medical records
•-Participants has been prescribed treatment with factor VIII concentrates 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. Japan, South Korea and Taiwan: Please see local requirements in Appendix9_section10.9
•-Body weight >=30 kg
•-Applicable to participants treated with on-demand/no prophylaxis prior to enrolment: >=5 bleeds in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed
•-Applicable to participants with FVIII activity >= 1% who are on prophylactic treatment:>=1 bleed in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed

•-Any disorder, except for conditions associated with haemophilia A, which in the investigators opinion might jeopardise participants safety or compliance with the protocol
•-Known or suspected hypersensitivity to study product(s), any constituents of the product or to related products
•-Receipt of gene therapy at any given time point
•-Ongoing or planned ITI therapy
•-Major surgery planned at the time of screening.
•-Known congenital or acquired coagulation disorders other than haemophilia A
•-Hepatic dysfunction defined as AST and/or ALT >3 times the upper limit combined with total bilirubin >1.5 times the upper limit measured at screening
•-Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) <=30 ml/min/1.73 m2 for serum creatinine measured at screening
•-Previous or current thromboembolic disease or eventsa (with the exception of previous catheter-associated thrombosis for which anti-thrombotic 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

发起方

Esaki Risa