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 solution for injection
INN or Proposed INN: N/A
CAS Number: 117551271-6
Current Sponsor code: NNC 0156-0
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 • Patients currently on prophylaxis or patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months 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) • HIV positive, defined by medical records with viral load =400,000 copies/mL and/or CD4+ lymphocyte count =200/µL • Congenital or acquired coagulation disorders other than haemophilia B • 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) • Platelet count 3 times the upper limit of normal reference ranges at screening (central laboratory) • Creatinine level =1.5 times above upper normal limit at screening (central laboratory) • Immune modulating or chemotherapeutic medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunogenicity of NNC-0156-0000-0009;Secondary Objective: • To evaluate clinical efficacy of haemostasis (treatment of bleeding episodes) of NNC-0156-0000-0009 • To evaluate clinical efficacy of NNC-0156-0000-0009 in long term bleeding prophylaxis (number of bleeding episodes during prophylaxis) • To evaluate the efficacy of NNC-0156-0000-0009 by the surrogate marker for efficacy, FIX activity • To evaluate general safety of NNC-0156-0000-0009;Primary end point(s): Incidence of inhibitory antibodies against FIX defined as titre =0.6 BU | — |
Countries
France, Germany, Italy, Netherlands, United Kingdom
Outcome results
None listed