Nuwiq Dosing and outcomes In the ManagEment of women/girls with haemophilia A Needing FVIII treatment for Surgery – an International, Open-label, Non-controlled study (NuDIMENSION)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 10
- 主要终点
- The overall haemostatic efficacy of Nuwiq in women/girls with haemophilia A undergoing major surgery assessed at the end of surgery by the surgeon and at the end of the POP by the investigator. Overall haemostatic efficacy will be adjudicated by the IDMC, using a pre-defined algorithm. The end of the POP for a surgical event will be defined as completion of wound healing, as defined by the investigator. Subsequent dosing of Nuwiq, if necessary, will not included in the assessment of efficacy
研究概览
简要总结
To evaluate the overall perioperative haemostatic efficacy of Nuwiq in women/girls with haemophilia A undergoing major surgery.
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 65+ Years, 0-17 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women/girls with haemophilia A (FVIII activity [FVIII:C] ≥1 - <40%) according to medical history
- •At least 12 years of age
- •Scheduled to undergo 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 inhibitors (≥0.6 Bethesda units [BU]/mL)
- •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 medicinal product (IMP) 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 overall haemostatic efficacy of Nuwiq in women/girls with haemophilia A undergoing major surgery assessed at the end of surgery by the surgeon and at the end of the POP by the investigator. Overall haemostatic efficacy will be adjudicated by the IDMC, using a pre-defined algorithm. The end of the POP for a surgical event will be defined as completion of wound healing, as defined by the investigator. Subsequent dosing of Nuwiq, if necessary, will not included in the assessment of efficacy
The overall haemostatic efficacy of Nuwiq in women/girls with haemophilia A undergoing major surgery assessed at the end of surgery by the surgeon and at the end of the POP by the investigator. Overall haemostatic efficacy will be adjudicated by the IDMC, using a pre-defined algorithm. The end of the POP for a surgical event will be defined as completion of wound healing, as defined by the investigator. Subsequent dosing of Nuwiq, if necessary, will not included in the assessment of efficacy
次要结局
- 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
- Perioperative haemostatic efficacy assessed using the 4-point scale recommended by the WFH (1)
- Incidence of adverse events (AEs)
- Incidence of thrombotic events
- Incidence of FVIII inhibitor formation
- The number of allogeneic blood products (red blood cells, platelets, and other blood products) transfused
研究者
Sigurd Knaub, PhD, SVP CRD Haematology
Scientific
Octapharma AG