Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.

Completed · Phase 3

Conditions studied: Congenital Bleeding Disorder, Haemophilia A

In brief

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.

Key facts

Study ID

NCT01489111

Run by

Novo Nordisk A/S

People needed

36

Starts

2012-08-03

Expected to finish

2018-12-10

Last updated by the study team

2020-08-10

Who can join

Age: 12 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Long Beach, California, United States
• Novo Nordisk Investigational Site — Sacramento, California, United States
• Novo Nordisk Investigational Site — Torrance, California, United States
• Novo Nordisk Investigational Site — Orlando, Florida, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — Boise, Idaho, United States
• Novo Nordisk Investigational Site — Iowa City, Iowa, United States
• Novo Nordisk Investigational Site — New Orleans, Louisiana, United States
• Novo Nordisk Investigational Site — Baltimore, Maryland, United States
• Novo Nordisk Investigational Site — Newark, New Jersey, United States
• Novo Nordisk Investigational Site — Cincinnati, Ohio, United States
• Novo Nordisk Investigational Site — Portland, Oregon, United States
• Novo Nordisk Investigational Site — Philadelphia, Pennsylvania, United States
• Novo Nordisk Investigational Site — Charleston, South Carolina, United States
• Novo Nordisk Investigational Site — Nashville, Tennessee, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States
• Novo Nordisk Investigational Site — Norfolk, Virginia, United States
• Novo Nordisk Investigational Site — Spokane, Washington, United States
• Novo Nordisk Investigational Site — Camperdown, New South Wales, Australia
• Novo Nordisk Investigational Site — South Brisbane, Queensland, Australia
• Novo Nordisk Investigational Site — Parkville, Victoria, Australia
• Novo Nordisk Investigational Site — Campinas, São Paulo, Brazil
• Novo Nordisk Investigational Site — Sofia, Bulgaria
• Novo Nordisk Investigational Site — Split, Croatia
• Novo Nordisk Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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