jRCT2041230047招募中不适用
Open-label, long-term safety and efficacy study of Mim8 in participants with haemophilia A with or without inhibitors(NN7769-4532) (FRONTIER 4)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 425
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 1age old over 至 No limit（—）
- 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 based on medical records.
- •3.Ongoing participation in study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769 4728 at the time of transfer. Participant should qualify either of the following criteria:
- •a.Participant from study NN7769-4513, who has participated in the extension part of the study for at least 12 weeks prior to enrolment in study NN7769-4532, or,
- •b.Participant has completed the end of treatment visit for study NN7769-4514, NN7769 4516, or NN7769-
- •4.Participant and/or participant's parent(s)/participant's legally acceptable representative (LAR) willingness and ability to comply with scheduled visits and study procedures, including the completion of diary.
排除标准
- •1.Any disorder, except for conditions associated with haemophilia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •2.Participant who has discontinued or been withdrawn from studies NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-
- •3.Previous participation in this study. Participation is defined as signed informed consent.
- •4.Female who is pregnant, breast-feeding or intends to become pregnant.
- •5.Female of child-bearing potential and not using a highly effective contraceptive method (highly effective contraceptive measures as defined in Appendix 4 or as required by local regulation or practice).
- •6.Participation (i.e., signed informed consent) in any interventional, clinical study (except from study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728) of an approved or non-approved investigational medicinal product.
- •Any planned majors surgery, during part1 of the study, For definition of major surgery see Table6-
- •8.Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.
结局指标
主要结局
-
Number of treatment-emergent adverse events (TEAEs)
次要结局
未报告次要终点
研究者
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