Haemonine - Post marketing study for long-term treatment of Haemophilia B patients (NIS Haemonine)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Haemonine
• Medical condition to be studied:
  Coagulation factor deficiency

Population studied

• Short description of the study population:
  Haemophilia B patients.
• Age groups:
  • Adolescents (12 to < 18 years)
  • Children (2 to < 12 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Haemophilia B patients
• Estimated number of subjects:
  50

Study design details

• Main study objective:
  Determination of the incidence and nature of adverse events and of the effectiveness of Haemonine
• Data analysis plan:
  Factor IX consumption, overall assessment on efficacy and ease of use, incidence and nature of adverse events