Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)

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
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, uncontrolled, multi-center, open-label, post-marketing surveillance study

Study drug and medical condition

• Name of medicine:
  HYQVIA
• Medical condition to be studied:
  Primary immunodeficiency syndrome

Population studied

• Short description of the study population:
  The study involved adult subjects aged 16 years or older with primary immunodeficiency diseases (PIDD) who were prescribed or initiated treatment with HYQVIA to assess the safety and tolerability data under routine clinical conditions.; Inclusion criteria: ; • Subject requires immunoglobulin treatment for PIDD; • Subject age is compatible with local package insert requirements (US ≥ 16, EU ≥ 18 years of age); • Subject has been prescribed or has started treatment with HYQVIA; • Subject is willing and able to comply with the requirements of the protocol; ; Exclusion criteria:; • Subject has known hypersensitivity to any of the components of the medicinal product; • Subject has participated in an interventional clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in an interventional clinical study involving a medical product or device during the course of this study; • Subject is a family member or employee of the investigator
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  250

Study design details

• Main study objective:
  The primary objective is to collect and assess additional safety data, in particular the occurrence of long-term changes in incidence and severity of related adverse events in patients treated with HYQVIA
• Outcomes:
  Incidence of all related serious adverse events (SAEs), Safety: - all SAEs and non-SAEs - immunologic AEs Treatment: 1. Regimen: - dose - infusion interval 2. Administration: - infusion volume - maximum infusion rate - mean infusion rate - duration of infusion - number of infusion sites Health-related quality of life and health resource use assessments
• Data analysis plan:
  Statistical analyses and data displays will be mainly descriptive. Data from all enrolled subjects will be included in the analysis. If groups of sufficient sample size (such as: age groups, PIDD types) are available, confidence intervals may accompany the point estimates. All SAEs and non-serious AEs will be categorized according to MedDRA system organ class (SOC) and preferred term. Concomitant medications and non-drug therapies will be recorded and tabulated. Tables will be prepared to list for each SAE and non-serious AE the number of events and the number of subjects who experienced one or more events.