A Prospective, Multicentre, Non-interventional, Observational, Post-authorisation Safety Study of Ropeginterferon alfa-2b in Polycythaemia Vera Patients (Besremi-PASS)

Study type

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

  Safety study (incl. comparative)

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ROPEGINTERFERON ALFA-2B
• Anatomical Therapeutic Chemical (ATC) code:
  (L03AB15) ropeginterferon alfa-2b

  ropeginterferon alfa-2b
• Medical condition to be studied:
  Polycythaemia vera

Population studied

• Age groups:
  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:
  228

Study design details

• Main study objective:
  To assess the incidence rate of the important, identified risk “hepatotoxicity” in PV patients newly treated with ropeginterferon alfa-2b in routine post-authorization use.
• Outcomes:
  Incidence of significant elevations of liver enzymes and/or bilirubin, and treatment-emergent hepatobiliary adverse drug reactions during the observational phase (i.e. first 6 months of treatment). Incidence of significant elevations of liver enzymes and/or bilirubin, and treatment-emergent hepatobiliary adverse drug reactions over the entire study period.Incidence of cardiovascular adverse events (i.e. thromboembolic adverse events and Major Adverse Cardiac Events) during the observation phase and over the entire study period.
• Data analysis plan:
  Absolute and relative frequencies of patients with treatment emergent adverse events, count and incidence rate (including two-sided 95% CIs) of events overall and by MedDRA primary System Organ Class and Preferred Term will be calculated.

Documents

Study, other information

Besremi-PASS_Protocol Redacted_V2.2_16Jun2020