Analysis of the Burden of Cytomegalovirus Infection and Disease in Hematopoietic Stem Cell Transplant Recipients

Study identification

• EU PAS number:
  EUPAS24403
• Study ID:
  24404
• Official title and acronym:
  Analysis of the Burden of Cytomegalovirus Infection and Disease in Hematopoietic Stem Cell Transplant Recipients
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This is a singlecentre, retrospective, observational study, in which we will explore the incidence of CMV reactivation and disease in patients undergoing allogeneic stem cell transplantation. We will analyze the dynamics of PCR values and the response to the different treatment options. We will also evaluate the health economics associated with CMV infection in this setting. We will interrogate a database of approximately 350 HSCT patients, that have received stem cell transplantation at the BMT Unit of the Hammersmith Hospital between early 2004 and 2015/2016 (minimum follow-up period of one year). The study is sponsored and funded by Merck Sharp & Dohme Ltd, UK.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Imperial College London

United Kingdom

Blood and marrow transplantation unit

Networks

NIHR Medicines for Children Research Network

Study timelines

Date when funding contract was signed

Planned: 01/10/2017

Actual: 09/10/2017

Study start date

Planned: 01/12/2017

Actual: 09/12/2017

Data analysis start date

Planned: 10/12/2017

Actual: 20/12/2017

Date of final study report

Planned: 15/06/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Ltd

Regulatory

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

Other study registration identification numbers and links

REC/HRA reference: 17/LO/1994NIHR CRN Reference: CANC 37047IRAS number: 237860