NN7088-4557: Adverse Event Data Collection from the EUHASS Registry on Turoctocog alfa pegol

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TUROCTOCOG ALFA PEGOL
• Medical condition to be studied:
  Haemophilia A without inhibitors

Population studied

• Age groups:
  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)
• Estimated number of subjects:
  50

Study design details

• Main study objective:
  To investigate the safety of long-term exposure to turoctocog alfa pegol in patients with haemophilia A.
• Outcomes:
  Adverse events (AEs) reported to the registry with suspected relation to turoctocog alfa pegol, Adverse Drug Reactions (ADRs), in patients with haemophilia A for renal, hepatic and neurological events. Other AEs reported to the registry during the study period with suspected relation to turoctocog alfa pegol in patients with haemophilia A including ADRs of special interest (de novo FVIII inhibitors equal to or above 0.6 Bethesda Units (BU)), anaphylaxis and other allergic reactions, thromboembolic events).
• Data analysis plan:
  This is a purely descriptive study and the statistical analyses and presentations do not include any testing of pre-specified hypotheses.