Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- The overall haemostatic efficacy of Nuwiq in severe haemophilia A patients receiving emicizumab prophylaxis and undergoing major surgery. Efficacy will be assessed at the end of surgery by the surgeon and at the end of the POP (up to 24 hours after the last injection of Nuwiq) by the investigator (haematologist) using a 4 point ordinal haemostatic efficacy scale. Overall haemostatic efficacy will be adjudicated by the Independent Data Monitoring Committee using a predefined algorithm.Â
研究概览
简要总结
"Patients with severe haemophilia A receiving emicizumab will often need concomitant FVIII to provide haemostatic cover during major surgery. This prospective, open-label, uncontrolled, single-arm, multinational, multicentre study aims to evaluate the overall perioperative haemostatic efficacy of Nuwiq, a recombinant factor VIII, in combination with emicizumab prophylaxis in male patients over 12 with severe haemophilia A undergoing major surgery
In the absence of neutralising FVIII inhibitors, haemostatic cover can be provided with concomitant FVIII. However, prospective data on the efficacy and safety of concomitant use of FVIII and emicizumab from clinical trials are limited.
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
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •Severe haemophilia A (FVIII activity [FVIII:C] less than 1%) according to medical history 2)Male patients at least 12 years of age 3)Previous treatment with any FVIII product(s) for at least 150 exposure days 4)On regular prophylaxis with emicizumab for at least 1 month prior to a scheduled major elective surgery requiring FVIII treatment 5)Freely given written informed consent of the patient, or parent or legal representative where applicable, obtained in accordance with local regulations Surgery is defined as major if any of the following criteria are met: Requiring general or spinal anaesthesia Requiring opening into the great body cavities Orthopaedic interventions involving joints (ankle, knee, hip, wrist, elbow, shoulder) Surgeries or conditions in which the patients life is at stake.
排除标准
- •Coagulation disorder other than haemophilia A 2)Present or past FVIII inhibitor (morethan or equal to 0.6 Bethesda units [BU]per mL) according to medical history 3)Severe liver or kidney disease (alanine aminotransferase [ALT] and or aspartate aminotransferase [AST] levels more than 5 times the upper limit of normal; or creatinine more than 120 μmolperL) 4)Known hypersensitivity to Nuwiqs active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188) 5)Already had surgery in this study 6)Current participation in another interventional clinical trial 7)Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit.
结局指标
主要结局
The overall haemostatic efficacy of Nuwiq in severe haemophilia A patients receiving emicizumab prophylaxis and undergoing major surgery. Efficacy will be assessed at the end of surgery by the surgeon and at the end of the POP (up to 24 hours after the last injection of Nuwiq) by the investigator (haematologist) using a 4 point ordinal haemostatic efficacy scale. Overall haemostatic efficacy will be adjudicated by the Independent Data Monitoring Committee using a predefined algorithm.Â
时间窗: During surgery and up to 24 hours after last injection of Nuwiq
次要结局
- The secondary endpoints of this study are:(1) Assessment of intraoperative haemostatic efficacy of Nuwiq using a 4 point ordinal scale)
研究者
Siva Subramanian
Allucent India Pvt Ltd