Swiss Soliris® aHUS Reimbursement Registry SSaRR: Observational registry of patients suffering from atypical Hemolytic Uremic Syndrome (aHUS) who are treated with Soliris® (Eculizumab)

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational registry

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA25) eculizumab

  eculizumab
• Medical condition to be studied:
  Atypical haemolytic uraemic syndrome

Population studied

• 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)
• Estimated number of subjects:
  20

Study design details

• Main study objective:
  Collection of medical information related to the initiation and continuation of therapy for patients suffering from atypical Hemolytic Uremic Syndrome (aHUS) who are treated with Soliris (Eculizumab).
• Outcomes:
  parameters:Platelet-countHemoglobin level (or Haptoglobin level)Presence of schistocytesLDH-levelNumber of plasma interventionsOrgan functions/complicationsQuality of Life
• Data analysis plan:
  The statistical evaluation of will be laid out according to the reporting requirements for the FOPH/BAG. Mainly descriptive statistics will be applied.