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 identification

• EU PAS number:
  EUPAS8028
• Study ID:
  25888
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Italy

  Netherlands

  Switzerland

  United Kingdom
• Study description:
  RDC Objectives• 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. • If HBV-HCC (hepatocellular carcinoma) is the reason for LT or HBV-HCC is detected in the explanted liver the rate of HBV-HCC recurrence. RDC DesignRetrospective, non-interventional, uncontrolled, single-arm, international, multi-centre, post-approvalRDC PopulationMale and female adult patients after LT for HBV-induced liver failure
• Study status:
  Finalised

Research institutions and networks

Institutions

Beckebaum

Multiple centres: 20 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 18/12/2014

Actual: 09/12/2014

Study start date

Planned: 19/01/2015

Actual: 19/01/2015

Data analysis start date

Planned: 01/07/2016

Date of final study report

Planned: 31/12/2016

Actual: 24/05/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biotest AG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only