Real Life, Long-term Effectiveness and Safety of Zutectra Self-Administration for HBV Re-Infection Prophylaxis after Liver Transplantation in France and Spain (Zutectra NIS)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, single-arm, multicentre, international post-approval study

Study drug and medical condition

• Name of medicine:
  ZUTECTRA
• Medical condition to be studied:
  Liver transplant

Population studied

• Short description of the study population:
  The study population involved 18 years or older aged patients with liver transplant (LT) received treatment with Zutectra.; Inclusion criteria:; 1. Patients 18 years or older.; 2. Patients with LT for fluminant hepatitis B, hepatitis B- cirrhosis, HBV-induced HBV-HCC, or with liver re-transplantation except due to HBV recurrence.; 3. Subjects under Zutectra treatment without or with a virostatic treatment.; 4. Written informed consent to allow data collection and data transfer to third party.
• 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
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  Determination of the number of patients with at least one hepatitis B related recurrence as assessed by detection of HBsAg (HBsAg positive) and/or HBV-DNA The determination of the number and nature of adverse events (AEs) including relatedness to Zutectra
• Outcomes:
  Proportion and absolute number of patients with at least one hepatitis B related recurrence as assessed by detection of HBsAg (HBsAg positive) and/or HBV-DNA Number and nature of adverse events (AEs) including relatedness to Zutectra, The achieved mean serum HBIg trough levels under Zutectra treatment as determined at clinical visits. Safety laboratory parameters like liver and kidney function. Compliance: Adherence to the sc treatment with Zutectra. Patient satisfaction and quality of life.
• Data analysis plan:
  All analyses will be performed in an exploratory sense. Since there are no confirmatory analyses planned, hypotheses are not formulated. Data will be analysed using descriptive statistics.