Eptacog beta post marketing safety surveillance using aggregated data reports from the EUHASS Registry (F7TG2206-EUHASS Registry)

Study type

• Study type:
  Not applicable
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• If ‘Not applicable’, further details on the study type:
  Post marketing safety study based on EUHASS Registry

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  EPTACOG BETA (ACTIVATED)
• Medical condition to be studied:
  Factor VIII deficiency

  Factor IX deficiency
• Additional medical condition(s):
  with inhibitors

Population studied

• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • 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:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  168

Study design details

• Main study objective:
  The primary objective will be to determine the number and incidence of important potential risks defined as: - Hypersensitivity reactions - Thromboembolic events, including those due to drug-drug interactions with activated or nonactivated prothrombin complex or other haemostatic agents - Immunogenicity
• Outcomes:
  - Number of allergic or other acute event and thromboses - Incidence of allergic or other acute event and thromboses - Incidence of antidrug antibodies
• Data analysis plan:
  Data management including data collection is under the responsibility of the EUHASS registry, in accordance with the current version of the EUHASS working protocol. At the end of each 3-month period, participating centres have 3 weeks to report their data, so the three-monthly report can be produced within four weeks of the end of each surveillance period. Every 12 months, a more detailed analysis is provided. The number and incidence of subjects with treatment-emergent AEs (TEAEs), specifically allergic or other acute events, thrombosis will be assessed and presented in a final report.