International documentation on the use of Cytotect CP® Biotest for patients after lung and heart transplantation (NIS-021 Cytotect)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000049
• EU PAS number:
  EUPAS47920
• Study ID:
  1000000049
• Official title and acronym:
  International documentation on the use of Cytotect CP® Biotest for patients after lung and heart transplantation (NIS-021 Cytotect)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Croatia

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  Non-interventional, prospective/retrospective, single-arm, uncontrolled, multi-centre, international, post approval study. Assessment of the real-world usage of Cytotect CP® Biotest in patients after heart and lung transplantation. The aim of this NIS is to understand the actual usage of Cytotect in the context with other CMV treatments and immunosuppressive regimens and to draw conclusions on the real-world relevance, efficacy and safety of the different prophylaxis and treatment approaches.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Biotest

26 centres are involved in this study

Study timelines

Date when funding contract was signed

Planned: 30/11/2021

Actual: 30/11/2021

Study start date

Planned: 01/05/2022

Actual: 01/01/2023

Data analysis start date

Planned: 31/10/2026

Date of final study report

Planned: 15/03/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biotest GmbH

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable