Haemophilia A MedDRA version: 20.0 Level: LLT Classification code 10018937 Term: Haemophilia A System Organ Class: 100000004850
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
Male
Inclusion 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 pathfinderTM 2 (NN7088-3859) and having received =5 doses of N8-GP - 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
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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the haemostatic effect of N8-GP during surgical procedures in patients with haemophilia A ; Secondary Objective: - To evaluate the general safety including immunogenicity of N8-GP when used for prevention and treatment of bleeding throughout the surgical period - To evaluate the haemostatic effect of N8-GP during the post-operative period - To evaluate health economic resource use (hospitalisation days) due to surgery ; Primary end point(s): 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 ;Timepoint(s) of evaluation of this end point: During surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Average consumption of N8-GP during surgery - Haemostatic effect of N8-GP during the post-operative period Days 1-6 and 7-14 - Average consumption of N8-GP during the post-operative period Days 1-6 - Incidence rate of inhibitors against factor VIII (FVIII) (=0.6 BU/mL) ;Timepoint(s) of evaluation of this end point: The endpoints will be analysed based on all available information until End of Trial (EOT) Visit and up to approximately 5 weeks for each patient. | — |
Countries
Australia, Brazil, Bulgaria, Croatia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Norway, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Registry (GCR.1452)
Novo Nordisk A/S
Outcome results
None listed