CMV in allogeneic hematopoietic stem cell transplant patients, v4.0
Research type
Research Study
Full title
Multinational CMV Outcomes, Treatment Patterns and Healthcare Resource Utilization Study following Hematopoietic Stem Cell Transplant (OTUS HSCT)
IRAS ID
287134
Contact name
Varun Mehra
Contact email
Sponsor organisation
Shire Human Genetic Therapies, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
Cytomegalovirus (CMV) is one of the most common infectious pathogens in transplanted patients. However, contemporary real-world evidence data on CMV infection following hematopoietic stem cell transplant (HSCT) is limited. This study will evaluate real-world data in the United States and Europe, with the objective of better understanding the burden of CMV infection and outcomes in HSCT patients. It is a multinational, non-interventional, retrospective study, involving only the collection of data which was previously documented in Patient’s medical charts, during routine healthcare. There is no disease or condition being treated, and no tests or procedures will be performed to the included Patients.
The main objective of the study is to evaluate and describe the clinical outcomes of CMV infection with current management patterns. In addition, this study is also designed to addressed other secondary objectives, namely: to describe the treatment patterns of CMV management; to describe the Patient/clinical characteristics of HSCT recipients; and to describe the economic burden and healthcare resource utilization of CMV infection.
Two independent groups of HSCT Patients with CMV infection, who were previously treated with at least one anti-CMV agent, are foreseen to be included in the study: i) Group 1 – Patients considered resistant, refractory or intolerant to currently available treatment; or i) Group 2 – Patients who received pre-emptive treatment for CMV viremia.
Patients will be selected in accordance with a set of criteria defined in the study protocol, irrespective of their survival status at the time of collection of the retrospective data from their medical records.REC name
London - Surrey Research Ethics Committee
REC reference
20/LO/1105
Date of REC Opinion
11 Dec 2020
REC opinion
Further Information Favourable Opinion