EUCTR2020-001048-24-DE进行中（未招募）1 期
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.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 247
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.Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
- •2.Male or female participants with diagnosis of congenital haemophilia A of any severity based on medical records
- •3.Participants has been prescribed treatment with factor VIII concentrates or bypassing agent in the last 26 weeks prior to screening
- •4.Age above or equal to 12 years at the time of signing informed consent.
- •5.Body weight greater than or equal to 30 kg
- •6.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
- •7.Applicable to participants with FVIII activity greater than or equal to 1% who are on prophylactic treatment: greater than or equal to 1 bleed in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed
- •8.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: 69
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 168
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Previous participation in this study. Participation is defined as signed informed consent
- •2.Participation (i.e., signed informed consent) in any interventional clinical study with receipt of the last dose within 6 months (or 5 half-lives of the investigational medicinal product, whichever is shorter) before planned randomisation.
- •3.Exposure to non-factor haemostatic products for bleeding prophylaxis within 6 months (or 5 half-lives of the medicinal product, whichever is shorter) before planned randomisation, for participants not included in the run-in.
- •4.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 Section ?10.4 or as required by local regulation or practice). Breast feeding is allowed only during the run-in period.
- •5.Any disorder, except for conditions associated with haemophilia A, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
- •6.Known or suspected hypersensitivity to trial product(s), any constituents of the product or to related products.
- •7.Receipt of gene therapy at any given time point.
- •8.Ongoing or planned immune tolerance induction (ITI) therapy.
- •9.Major surgery planned to take place after screening.
- •10.Known congenital or acquired coagulation disorders other than haemophilia A.
- •11.Hepatic dysfunction defined as AST and/or ALT greater than 3 times the upper limit combined with total bilirubin greater than 1.5 times the upper limit measured at screening.
- •12.Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) less than or equal to 30 ml/min/1.73 m2 for serum creatinine measured at screening.
- •13.Previous or current thromboembolic disease or events (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.
- •14.Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.
- •15.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
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