A retrospective data collection to increase the knowledge base of posttransplant treatment with the human hepatitis B immunoglobulin Zutectra or Hepatect CP in liver transplanted patients (Hepatect CP / Zutectra RDC)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ZUTECTRA
• Name of medicine, other:
  Hepatect CP
• Medical condition to be studied:
  Liver transplant

Population studied

• Short description of the study population:
  Male and female adult patients after liver transplantation (LT) for hepatitis B virus (HBV)-induced liver failure.
• 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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  The effectiveness of long-term protection from HBV-recurrence after liver transplantation (LT) using subcutaneous Zutectra® or iv Hepatect® CP and / or a further hepatitis B immunoglobulin (HBIg) in the same patient.
• Outcomes:
  HBV-recurrence after liver transplantation, HBV-HCC (hepatocellular carcinoma) recurrence after liver transplantation
• Data analysis plan:
  Descriptive statisticsProportion and absolute number of HBV-liver transplant patients free of hepatitis B virus recurrence as assessed by non-detectability of HBsAg and / or HBV-DNA in patients' sera.The rate of HBV-HCC recurrence, if HBV-HCC is the reason for LT or HBV-HCC is detected in the explanted liver.