EUCTR2011-001144-30-ITActive, not recruitingPhase 1
Efficacy and Safety of NNC 0129-0000-1003 (N8-GP) during Surgical Procedures in Patients with Haemophilia A - Pathfinder™ 3
OVO NORDISK0 sites53 target enrollmentStarted: August 2, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 53
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •- Informed consent obtained before any trial-related activities. (Trialrelated
- •activities are any procedure that would not have been performed
- •during normal management of the subject.)
- •- Ongoing participation in the pathfinderTM 2 (NN7088-3859) or the
- •pathfinderTM 4 (NN7088-3861) trial and having received =5 doses of
- •- 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
Exclusion Criteria
- •- Known or suspected hypersensitivity to trial product including allergy
- •to hamster protein or related products
- •- Previous withdrawal from the pathfinderTM 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 = 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
Investigators
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