Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in Real-World Setting (PASSPORT)

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:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Safety Registry

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AX) Other immunosuppressants

  Other immunosuppressants
• Medical condition to be studied:
  Idiopathic pulmonary fibrosis

Population studied

• Short description of the study population:
  Patients with idiopathic pulmonary fibrosis (IPF) with newly prescribed Esbriet® therapy or within less then 30 days prior to study enrolment.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Idiopathic pulmonary fibrosis patients
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The objective of this study is to evaluate the long-term safety profile of Esbriet® in patients with IPF and to monitor for any unknown or potential risks of treatment with Esbriet®.
• Data analysis plan:
  All data will be analyzed in a descriptive manner, no formal hypotheses will be tested. Frequencies and incidence rates of reported adverse drug reactions (ADRs) will be summarized by MedDRA SOC, HLT, and PT. Clinical characteristics of the study population will be analyzed by frequency and percentages for categorical variables and by mean, standard deviation, minimum, median, and maximum for continuous variables. The study population for analysis of safety will include all patients who receive at least one dose of Esbriet® regardless of the length of follow up.