CTRI/2024/02/062683招募中3 期
Open-label, long-term safety and efficacy study of Mim8 in participants withhaemophilia A with or without inhibitors - NN7769-4532 (FRONTIER 4)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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
- •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 4513, 4514, 4516, or 4728 at the time of transfer. Participant should qualify either of the following criteria:
- •a. Participant from study 4513, who has participated in the extension part of the study for at least 12 weeks prior to enrolment in study 4532, or,
- •b. Participant has completed the end of treatment visit for study 4514,4516, or 4728.
- •4. Participant and/or participant’s parent(s)/participant’s 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 Participant who has discontinued or been withdrawn from studies 4513, 4514, 4516, or 4728.
- •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
- •6. Participation (i.e., signed informed consent) in any other interventional clinical study (except from study 4513, 4514, 4516, or 4728) of an approved or non-approved investigational medicinal product.
- •7. Any planned major surgery, during part 1 of the study.
- •8. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.
研究者
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