CTRI/2023/02/049474尚未招募3 期
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. - Frontier 2
ovo Nordisk AS0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
- •Male or female participants with diagnosis of congenital haemophilia A of any severity based on medical records.
- •Participant 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.
- •Body weight greater than or equal to 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.
- •Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires.
排除标准
- •1. Previous participation in this study. Participation is defined as signed informed consent.
- •2. Participation (that is, 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 hemostatic 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. Breast feeding is allowed only during the run-in period.
- •5. Any disorder, except for conditions associated with hemophilia A, which in the investigators opinion might jeopardise participants 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 hemophilia A.
- •11. 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.
- •12. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below or equal to 30 ml per min per 1.73 meter square 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.
- •Other conditions (example, 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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