Vanderbilt Clinical Trials

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

Purpose

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.

Conditions

Congenital Bleeding Disorder
Haemophilia A

Eligibility

Eligible Ages: Over 12 Years
Eligible Genders: Male
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Surgery		Drug: turoctocog alfa pegol Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses. Other names: NNC 0129-0000-1003

More Details

Status: Completed
Sponsor: Novo Nordisk A/S

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.