A post-marketing surveillance study for Repatha Inj. (evolocumab) in Korea text (20160156)

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

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Single arm, prospective, observational study

Study drug and medical condition

• Name of medicine:
  REPATHA
• Medical condition to be studied:
  Hyperchloraemia

Population studied

• Short description of the study population:
  Adults and adolescents aged 12 years or older with homozygous familial hypercholesterolemia (HoFH) received treatment with Repatha under routine clinical settings in Korea. ; Inclusion criteria: ;  HoFH patient treated with Repatha Inj. according to the approved therapeutic indications, dosage, and administration in post-marketing settings ;  Patient who voluntarily provided written informed consent ; ; Exclusion criteria:;  Patient who did not provide written informed consent ;  There are no other exclusion criteria.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with homozygous familial hypercholesterolemia
• Estimated number of subjects:
  10

Study design details

• Main study objective:
  The primary objective of this study is to assess the incidence rate of adverse events (AEs) (including device related AEs) and adverse drug reactions (ADRs) for up to 12 weeks in patients who are prescribed Repatha according to the approved therapeutic indications, dosage, and administration in post-marketing settings
• Outcomes:
  incidence rate of AEs/ADRs observed or reported to the investigator during the follow-up period, Efficacy measurement, change in low-density lipoprotein (LDL)-cholesterol (LDL-C) measured as part of routine clinical practice from baseline to the end of follow-up, patient demographic information and medical history, diagnosis of hypercholesterolemia, concomitant medication prior to study participation, other concomitant medication
• Data analysis plan:
  Categorical variables will be summarized with frequency and percentage, and continuous variables will be summarized with mean, standard deviation (SD), standard error (SE), median, Q1, Q3, minimum, and maximum. Subject disposition, demographic information, and baseline characteristics will be summarized in the safety set. For safety analysis, number of subjects, number of events, and incidence rate will be presented in the safety set for AEs (including device related AEs), ADRs, and serious AEs (SAEs). 95% confidence interval will not be calculated because it is not meaningful for the planned sample size of 10 subjects. For efficacy analysis, change (%) in LDL-C at Week 12 from baseline will be analysed in the efficacy set.

Documents

Study results

20160156 ORSR_Redacted