Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.
Status: | Completed |
---|---|
Conditions: | Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 2/20/2019 |
Start Date: | August 3, 2012 |
End Date: | December 10, 2018 |
Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A
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.
of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
20
sites
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