2022-502060-21-00招募中4 期
Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis study (NuPOWER)
Octapharma AG, Octapharma AG11 个研究点 分布在 6 个国家目标入组 45 人开始时间: 2023年8月15日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 11
- 主要终点
- The primary endpoint is the overall haemostatic efficacy (“success” or “failure”) of Nuwiq in severe haemophilia A patients receiving emicizumab prophylaxis and undergoing major surgery.
研究概览
简要总结
The primary objective of this study is to evaluate the overall perioperative haemostatic efficacy of Nuwiq, in combination with ongoing emicizumab prophylaxis, in patients with severe haemophilia A undergoing major surgery.
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Severe haemophilia A (FVIII activity [FVIII:C] <1%) according to medical history.
- •Male patients at least 12 years of age.
- •Previous treatment with any FVIII product(s) for at least 150 exposure days.
- •On regular prophylaxis with emicizumab for at least 3 months prior to a scheduled major elective surgery requiring FVIII treatment.
- •Freely given written informed consent.
排除标准
- •Coagulation disorder other than haemophilia A.
- •Present or past FVIII inhibitor (≥0.6 Bethesda units [BU]/mL) according to medical history.
- •Severe liver or kidney disease (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] levels >5 times the upper limit of normal; or creatinine >120 μmol/L).
- •Current participation in another interventional clinical trial.
- •Treatment with any investigational product within 30 days prior to screening visit.
- •Known hypersensitivity to Nuwiq’s active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
- •Already had surgery in this study
结局指标
主要结局
The primary endpoint is the overall haemostatic efficacy (“success” or “failure”) of Nuwiq in severe haemophilia A patients receiving emicizumab prophylaxis and undergoing major surgery.
The primary endpoint is the overall haemostatic efficacy (“success” or “failure”) of Nuwiq in severe haemophilia A patients receiving emicizumab prophylaxis and undergoing major surgery.
次要结局
- Incidence of adverse events (AEs).
- Assessment of intraoperative haemostatic efficacy of Nuwiq using a 4-point ordinal scale.
- Assessment of postoperative haemostatic efficacy of Nuwiq using a 4-point ordinal scale.
- Perioperative FVIII plasma levels immediately before (≤30 minutes) and after (15-30 minutes) Nuwiq injections.
- Incidence of thrombotic events.
- Perioperative haemostatic efficacy assessed using the 4-point scale recommended by the WFH.
- Incidence of FVIII inhibitor formation.
- Number of allogeneic blood products (red blood cells, platelets, and other blood products) transfused
- Perioperative TG immediately before (≤30 minutes) and after (15-30 minutes) Nuwiq injections
研究者
Sigurd Knaub, SVP CRD Haematology
Scientific
Octapharma AG
研究点 (11)
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