Efficacy and Safety of NNC 0129-0000-1003 (N8-GP) during Surgical Procedures in Patients with Haemophilia A - pathfinder™ 3

ovo Nordisk A/S0 个研究点目标入组 53 人开始时间: 2011年12月27日最近更新: 2019年2月28日

试验速览

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•- 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 pathfinderTM 2 (NN7088-3859) trial and having received =5 doses of N8-GP
•- Undergoing major surgery (refer to Section 5.3.1 for definition) requiring daily monitoring of FVIII:C and wound status for =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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 2
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 16
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products
•- Previous withdrawal from the pathfinderTM 2 (NN7088-3859) 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 = 0.6 BU/mL at screening (refer to Section 8.1.1)
•- 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

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