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

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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.


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
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Baltimore, Maryland 21229
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Camperdown, New South Wales
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