CTRI/2025/08/092490尚未招募4 期
Safety of Eptacog Alfa in Severe Postpartum Haemorrhage in India: A Phase IV Interventional Study
Novo Nordisk India Pvt Ltd3 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年8月26日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- Number of thromboembolic events
研究概览
简要总结
This is an interventional, single arm, open label, Phase 4 study that will be conducted across multiple centres in India. In this study, the safety of eptacog alfa will be assessed in women with severe postpartum haemorrhage (PPH) in India in whom uterotonics were insufficient to attain haemostasis. Approximately 64 participants with severe PPH in India in whom uterotonics are insufficient to attain haemostasis will be enrolled in this study. All enrolled patients will receive one dose of eptacog alfa (60-90 µg/kg) and one additional dose of eptacog alfa (60-90 µg/kg) if required The total study duration is estimated to be 19 months. The study consists of an 18-month recruitment period, a 30-day follow-up period (This includes both 7-day follow-up visit and End of study visit – also referred to as 30day follow-up visit).
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研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Informed consent1 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 except for blood loss estimation post-partum
- •Adult women aged more than or equal to 18 years at the time of signing the informed consent and who deliver after 27 weeks diagnosed with severe PPH who fail to respond to uterotonics.
- •patients to have uterotonics failure i.e. patients in whom uterotonics were insufficient to attain haemostasis and for definition of severe PPH.
排除标准
- •1 Previous participation in this study.
- •Participation is defined as having given informed consent in this study 2 Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation 3 Patient with a history of thromboembolism2 4 Patient with a history of bleeding disorders3 5 Patient with a history of or ongoing disseminated intravascular coagulation (DIC); haemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome, thrombotic thrombocytopenic purpura (TTP), pre-eclampsia or other severe complication of childbirth apart from severe PPH.
- •6 Have undergone invasive obstetric procedures for the ongoing haemorrhage prior to trial enrolment (uterine balloon tamponade and external aortic compression not included) 7 Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise patient’s safety or compliance with the protocol 8 Participation (i.e., signed informed consent) in any other interventional clinical study prior to screening in the current study 1Note: The patient’s legally acceptable representative (LAR) may be approached to obtain the informed consent if the patient is not in an appropriate health condition to provide consent.
- •In a scenario where the LAR has provided informed consent, an additional informed consent will be obtained from the patient as soon as she is able to provide informed consent.
- •Includes arterial and venous thrombosis including myocardial infarction, pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events, and peripheral artery occlusion.
- •Patient with a history of known inherited or acquired coagulation disorder other than PPH.
- •Factor deficiencies such as haemophilia, acquired haemophilia, von Willebrand disease, other factor deficiencies and platelet disorders.
- •These can also include qualitative and quantitative platelet disorders.
结局指标
主要结局
Number of thromboembolic events
时间窗: From baseline (day 0) to end of study (day 30)
次要结局
- Number of serious adverse events(From baseline (day 0) to end of study (day 30))
- Number of allergic reactions(From baseline (day 0) to end of study (day 30))
- All medication errors(At the time of administration)
- Near medication errors(At the time of administration)
研究者
研究点 (3)
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