DARWIN EU® Characterization of patients with chronic hepatitis B and C

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Other

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J05AP) Antivirals for treatment of HCV infections

  (L03AB61) peginterferon alfa-2a, combinations
• Medical condition to be studied:
  Chronic hepatitis B

  Chronic hepatitis C

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  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:
  15800000

Study design details

• Main study objective:
  To estimate the number and percentage of individuals initiating or undergoing treatment with interferon or any of the specific antivirals of interests among patients with chronic HBV HCV infection, stratified by age, sex, calendar year and country/database during the study period.
• Data analysis plan:
  Analyses will be conducted separately for each database. Before study initiation, test runs of the analytics are performed on a subset of the data sources or on a simulated set of patients and quality control checks are performed. Once all the tests are passed, the final package is released in the version-controlled Study Repository for execution against all the participating data sources. The data partners locally execute the analytics against the OMOP CDM in R Studio and review and approve the by default aggregated results before returning them to the Coordination Centre. Sometimes multiple execution iterations are performed, and additional fine tuning of the code base is needed. A service desk will be available during the study execution for support. The study results of all data sources are checked after which they are made available to the team in the Digital Research Environment DRE and the Study Dissemination Phase can start. All results are locked and timestamped for repro.

Documents

Study report

DARWIN EU_D2.2.4_Report_P2-C1-010_HBV_HCV_Pts_Characterisation_v2.1.pdf