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Clinical Trials/EUCTR2011-001144-30-IT
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

Sponsor
OVO NORDISK

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