NCT01489111已完成3 期
Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Haemostatic Effect During Surgery Evaluated by the Four-point Scale, Assessed by the Investigator/Surgeon at the Day of Surgery - Four-point Response Scale: Excellent, Good, Moderate or None
研究概览
简要总结
This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- •Ongoing participation in the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial and having received greater than or equal to 5 doses of N8-GP
- •Undergoing major surgery requiring daily monitoring of FVIII:C (FVIII activity) and wound status for at least 3 days
- •The patient and/or Legally Acceptable Representative (LAR) is capable of assessing a bleeding episode, keeping an eDiary, capable of home treatment of bleeding episodes and otherwise capable of following the trial procedures
排除标准
- •Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products
- •Previous withdrawal from the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial after administration of trial product, except interruption due to inclusion in this pathfinderTM 3 trial (NN7088-3860)
- •The receipt of any investigational medicinal product (except N8-GP) within 30 days prior to enrolment into the trial. (For Brazil, only: Participation in a previous clinical trial within one year prior to screening for this trial (Visit 1), unless there is a direct benefit to the research subject, at the Investigator's discretion)
- •FVIII inhibitors at least 0.6 BU (Bethesda Units)/mL at screening
- •Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
- •Immune modulating or chemotherapeutic medication
- •Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's judgement, could imply a potential hazard to the patient, interfere with trial participation or trial outcome
- •Unwillingness, language or other barriers precluding adequate understanding and/or cooperation
研究组 & 干预措施
Surgery
Experimental
干预措施: turoctocog alfa pegol (Drug)
结局指标
主要结局
Haemostatic Effect During Surgery Evaluated by the Four-point Scale, Assessed by the Investigator/Surgeon at the Day of Surgery - Four-point Response Scale: Excellent, Good, Moderate or None
时间窗: Assessed by the Investigator/surgeon at the day of surgery
Haemostatic effect during surgery was evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'. This was assessed after completion of surgery (defined as "last stitch"). Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen. None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
次要结局
- Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6(During the post-operative period, days 1-6)
- Estimated Blood Loss During Surgery(During surgery)
- Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14(During the post-operative period, days 7-14)
- Number of Days in Intensive Care(During the trial (2-5 weeks))
- Average Consumption of N8-GP During Surgery(During surgery, defined as the time from "knife to skin" until "last stitch")
- Length of Stay in the Hospital(During the trial (2-5 weeks))
- Adverse Events Reported During the Trial Period(During the trial (2-5 weeks))
- Average Consumption of N8-GP During the Post-operative Period Days 1-6(During the post-operative period, days 1-6)
- Number of Transfusions During the Post-operative Period Days 1-6(Post-operative period, days 1-6)
- Incidence Rate of Inhibitors Against Factor VIII (FVIII) (≥0.6 BU/mL)(during the trial (2-5 weeks))
- Serious Adverse Events Reported During the Trial Period(During the trial (2-5 weeks))
研究者
研究点 (1)
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