Viread Observational, Cross -Sectional Drug Utilisation Study in Children and Adolescents with Chronic Hepatitis B (Viread HBV DUS)

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Chronic hepatitis B

Population studied

• Short description of the study population:
  All Chronic Hepatitis B (CHB) patients who initiate therapy with Viread before the age of 18 years. The participating physicians will complete questionnaires using their patient medical records retrospectively. Data will not be collected on the individual patient level, but will be aggregated at the site level.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Special population of interest:
  Hepatic impaired
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  To describe the characteristics of chronic hepatitis B patients less than 18 years old treated within the EU with Viread
• Outcomes:
  To describe the characteristics of chronic hepatitis B patients less than 18 years old treated within the EU with Viread, To describe how the pre-treatment and on treatment renal function and bone mineral density are monitoredTo determine if a multidisciplinary approach is taken in paediatric patient management, including renal and bone toxicities.
• Data analysis plan:
  Data from the surveys of prescribers of Viread to adolescents and children with CHB will be summarized descriptively (numbers, ranges, proportions)

Documents

Study results

GS-EU-174-0224 CSR Synopsis_f-redact