EUCTR2020-001048-24-DK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.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 244
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 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 above or equal to 30 kg
- •6. Applicable to participants treated with on-demand/no prophylaxis prior to enrolment: more than or equal to 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 above or equal to 1% who are on prophylactic treatment: more 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: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 204
- •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 in any clinical study 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
- •3. Exposure to non-factor haemostatic products for bleeding prophylaxis within 6 months (or 5 half-lives of the medicinal product, whichever is shorter) prior to planned first dose, 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 haemophilia A, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol
- •6. Known or suspected hypersensitivity to study 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 ITI therapy
- •9. Major surgery planned at the time of screening.
- •10. Known congenital or acquired coagulation disorders other than haemophilia A
- •11. Hepatic dysfunction defined as AST and/or ALT more than 3 times the upper limit combined with total bilirubin more 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 m^2 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
相似试验
进行中（未招募）
1 期
A research study investigating Mim8 in adults and adolescents with haemophilia A with or without inhibitorsHaemophilia A Haemophilia A with inhibitorsMedDRA version: 20.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850MedDRA version: 20.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000004850EUCTR2020-001048-24-SKovo Nordisk A/S247
进行中（未招募）
1 期
A research study investigating Mim8 in adults and adolescents with haemophilia A with or without inhibitorsHaemophilia A Haemophilia A with inhibitorsMedDRA version: 20.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850MedDRA version: 20.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000004850EUCTR2020-001048-24-NLovo Nordisk A/S244
进行中（未招募）
1 期
A research study investigating Mim8 in adults and adolescents with haemophilia A with or without inhibitors.Haemophilia AHaemophilia A with inhibitorsMedDRA version: 20.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850MedDRA version: 20.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000004850EUCTR2020-001048-24-ITOVO NORDISK. S.P.A.230
进行中（未招募）
1 期
A research study investigating Mim8 in adults and adolescents with haemophilia A with or without inhibitorsEUCTR2020-001048-24-DEovo Nordisk A/S247
尚未招募
3 期
A research study investigating Mim8 in adults and adolescents with haemophilia A with or without inhibitorsCTRI/2023/02/049474ovo Nordisk AS