NL-OMON51874招募中3 期
Safety, efficacy and exposure of subcutaneously administered NNC0365-3769 (Mim8) prophylaxis in children with haemophilia A with or without FVIII inhibitors - Frontier 3
ovo Nordisk0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 4
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
- 年龄范围
- 0 至 11（—）
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 and female participants with the diagnosis of congenital haemophilia A
- •of any severity based on medical records.
- •- Aged 1*11 years (both inclusive) at the time of signing informed consent.
- •- For previously treated participants :
- •a. Participant has been prescribed treatment with FVIII concentrate or
- •bypassing agent in the
- •last 26 weeks prior to screening.
- •b. Participant with endogenous FVIII activity >=1%, based on medical records,
- •must have at
- •least 1 treated bleed during the previous 26 weeks before screening for which
- •factor VIII
- •concentrate or bypassing agent has been prescribed (No requirements for
- •participants with
- •FVIII activity <1%).
- •- For previously untreated participants :
- •a. Diagnosis of severe haemophilia A (endogenous FVIII activity < 1%) based on
- •- Child and parent(s)/caregiver(s) willingness and ability to comply with
- •scheduled visits and
- •study procedures, including the completion of diary and patient-reported
- •questionnaires.
排除标准
- •- Known or suspected hypersensitivity to study product or related products.
- •- Previous participation in this study. Participation is defined as signed
- •informed consent.
- •- 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.
- •- Known congenital or acquired coagulation disorders other than haemophilia A.
- •- Other conditions (e.g. autoimmune disease) or laboratory abnormality that may
- •increase risk of bleeding or thrombosis, as evaluated by the investigator.
- •- Any disorder, except for conditions associated with haemophilia A, that in
- •the investigator*s opinion might jeopardise the participant*s safety or
- •compliance with the protocol.
- •- Mental incapacity, unwillingness to cooperate or a language barrier
- •precluding adequate understanding and cooperation.
- •- Lack of adequate parental/caregiver support to enter accurately and timely
- •information regarding treatment and bleeding episodes into an (electronic)
- •- Previous or current treatment for thromboembolic disease (with the exception
- •of previous catheter-associated thrombosis for which anti-thrombotic treatment
- •is not currently ongoing) or signs of thromboembolic disease.
- •- Major surgery planned to take place after screening.
- •- Immune tolerance induction planned to take place after treatment initiation.
- •- Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or
- •alanine aminotransferase (ALT) >3 times the upper limit of normal combined with
- •total bilirubin >1.5 times the upper limit of normal measured at screening.
- •- Serum creatinine above 1.5 x upper limit of normal (ULN), measured at
- •- Pregnancy (female participants).
研究者
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