Brief Title
Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.
Official Title
Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A
Brief Summary
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Haemostatic Effect During Surgery Evaluated by the Four-point Scale, Assessed by the Investigator/Surgeon at the Day of Surgery - Four-point Response Scale: Excellent, Good, Moderate or None
Secondary Outcome
Average Consumption of N8-GP During Surgery
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa pegol
Study Arms / Comparison Groups
Surgery
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
36
Start Date
August 3, 2012
Completion Date
December 10, 2018
Primary Completion Date
December 10, 2018
Eligibility Criteria
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
Gender
Male
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT01489111
Organization ID
NN7088-3860
Secondary IDs
U1111-1119-7326
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
July 2020