Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-28 @ 3:25 PM
Study NCT ID:
NCT06916195
Status:
RECRUITING
Last Update Posted:
2025-07-20
First Post:
2025-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Burden of Cytomegalovirus Reactivation in Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplantation
Sponsor:
MSD Italia S.r.l.
Organization:
Study Overview
Official Title:
CMV PED Study - A Retrospective Observational Study To Understand The Clinical And Economic Burden Associated With Cytomegalovirus Reactivation and Related Health Outcomes In Pediatric Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation In Italy
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CMV PED
Brief Summary:
This observational retrospective analysis will provide useful information for clinicians and payers, and local guidelines committee members, to improve the understanding of Cytomegalovirus clinical and economic burden and clinical management of pediatric patients undergoing allogeneic Hematopoietic Stem Cells Transplantation in Italy.
Detailed Description:
This is an observational retrospective analysis from the main pediatric centers in Italy (approximately 5 sites). The selected sites will be the most representative of Italy because they perform about 2/3 of all allogeneic HSCT per year.
Index date: date of allogeneic HSCT; retrospective data will be captured in consecutive patients undergoing allogeneic HSCT from January 2018 to June 2020 with maximum 12 months of follow-up for each patient. The data of the patients undergoing allogeneic HSCT after June 2020 will not be captured in order to avoid any possible bias due to off-label access to letermovir.
Medical Records (MR) will be used to describe the risk factors, patient characteristics, treatment patterns, and healthcare resource utilization of subjects who had a CMV infection.
Electronic or paper hospital charts (inpatient), clinical charts (inpatient and outpatient), and outpatient records will all be considered as MR for study purposes.
This is a secondary data collection study from electronic or paper medical chart review, no data from registry will be collected.
Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF), if applicable.
Index date: date of allogeneic HSCT; retrospective data will be captured in consecutive patients undergoing allogeneic HSCT from January 2018 to June 2020 with maximum 12 months of follow-up for each patient. The data of the patients undergoing allogeneic HSCT after June 2020 will not be captured in order to avoid any possible bias due to off-label access to letermovir.
Medical Records (MR) will be used to describe the risk factors, patient characteristics, treatment patterns, and healthcare resource utilization of subjects who had a CMV infection.
Electronic or paper hospital charts (inpatient), clinical charts (inpatient and outpatient), and outpatient records will all be considered as MR for study purposes.
This is a secondary data collection study from electronic or paper medical chart review, no data from registry will be collected.
Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF), if applicable.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: