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 identification

• EU PAS number:
  EUPAS8116
• Study ID:
  27428
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  France

  Spain
• Study description:
  Prospective documentation of long-term effectiveness, safety, convenience and patient adherence to Zutectra® subcutaneous self-administration for protection from HBV-recurrence after liver transplantation (LT) aiming at confirmation of existing data under real life conditions.
• Study status:
  Finalised

Research institutions and networks

Institutions

Biotest

Multiple centres: 18 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:12/01/2015

Actual:01/01/2015

Study start date

Planned:01/06/2015

Actual:01/06/2015

Data analysis start date

Planned:30/09/2020

Date of final study report

Planned:31/12/2020

Actual:17/06/2021

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)?:
  Not applicable