Haemophilia B MedDRA version: 12.1 Level: LLT Classification code 10018939 Term: Haemophilia B (Factor IX)
Conditions
Interventions
Product Name: N9-GP
Product Code: NNC 0156-0000-009
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: N/A
CAS Number: 117551271-6
Current Sponsor code: NNC 0156
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Patients with haemophilia B, aged 13-70 years and with a FIX activity of =2%. • Male patients with moderately severe or severe congenital haemophilia B with a FIX activity =2% according to medical records • History of at least 150 exposure days to other FIX products • Scheduled major surgery Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR interviews • Current FIX inhibitors =0.6 BU (central laboratory) • 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) • ALT >3 times the upper limit of normal reference ranges at screening (central laboratory) • Immune modulating or chemotherapeutic medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the haemostatic effect of NNC-0156-0000-0009 during surgery procedures in patients with haemophilia B;Secondary Objective: • To evaluate the haemostatic effect of NNC-0156-0000-0009 during surgery and the postoperative period • To evaluate the general safety, including immunogenicity of N9-GP, when used for prevention and treatment of bleeding during surgery and the post-operative period;Primary end point(s): Haemostatic effect during surgery evaluated by the four-point response scale, assessed by the Investigator/Surgeon at the day of surgery - Four-point response scale: Excellent, good, moderate, poor | — |
Countries
Austria, France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed