Utilization of Ribavirin in Pediatric Patients with Hepatitis C Virus - Aggregated Experience of European Specialists (MK-8908-060)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J05AB04) ribavirin

  ribavirin
• Medical condition to be studied:
  Hepatitis C

Population studied

• Short description of the study population:
  Pediatric patients (age <18 years of age) with HCV infection who received at least one dose of ribavirin during routine clinical practice in the respective time period (between July 25th, 2011 and July 24th, 2014).
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Special population of interest:
  Hepatic impaired
• Estimated number of subjects:
  10

Study design details

• Main study objective:
  The main objectives of the study are to estimate pediatric exposure to ribavirin solution and/or capsules among all children and adolescents with Hepatitis C (in proportions) and to describe demographic and disease characteristics of the pediatric population receiving ribavirin.
• Outcomes:
  The outcomes of interest in the pediatric population are the following: observation of prescribing behavior of ribavirin, utilization of ribavirin capsules and/or solution, demographic and disease characteristics of patients receiving ribavirin.
• Data analysis plan:
  Study analyses will be limited to descriptive data on ribavirin prescriptions and treatment patterns as well as patient demographic and disease characteristics. Descriptive data analysis of the aggregated information will be performed and the results will be displayed in tabulated form (summarized and, whenever reasonable, on country-level). Analysis will be stratified by adolescents (12 to <18 years) and non-adolescents (0 to <12 years).