Non-interventional study (NIS) for long-term monitoring of the treatment of hemophilia A with Haemoctin SDH (Haemoctin NIS)

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

  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:
  Haemoctin SDH
• Medical condition to be studied:
  Factor VIII deficiency

Population studied

• Short description of the study population:
  Hemophilia A patients treated with Haemoctin SDH.
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 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:
  Hemophilia A patients
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  With the present NIS data on effectiveness, tolerability and safety of the drug in the long-term treatment under real life conditions will be documented.
• Data analysis plan:
  Descriptive statistics will be applied for analysis of effectiveness and safety data.