The European HBV Registry: A joint initiative of TherVacB and DZIF (HBV Registry)

Study type

• Study topic:
  Disease /health condition

  Other
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Establishment and immunological characterisation of a patient cohort and associated viral markers
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Hepatitis B

Population studied

• Short description of the study population:
  Patients with hepatitis B mono- and co-infections
• Age groups:
  • 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:
  3000

Study design details

• Main study objective:
  Characterization of viral and immunological markers in hepatitis B patients. ; The knowledge gained should contribute to a better understanding of HBV control and enable patient stratification with regard to immunomodulatory therapies.
• Setting:
  Consortium of clinical partners
• Outcomes:
  HBsAg decline/loss, seroconversion to anti-HBs, Quantification of soluble immune mediators, Hepatitis B related Quality of Life (SF36), hepatocellular carcinoma (HCC), liver cirrhosis, death
• Data analysis plan:
  Quantification and characterization of viral markers and immunological patient markers.