A Study on Cytomegalovirus (CMV) Infection Outcomes Among Hematopoietic Stem Cell Transplant (HSCT) Participants in Europe and Canada

Takeda

Status: Completed

Conditions: Cytomegalovirus (CMV)

Study type: Observational

Funder types: Industry

Identifiers

NCT05571137

TAK-620-4004

Details and patient eligibility

About

The main aim of the study is to assess the clinical outcomes of current CMV management across different regions of the world (Europe [EU] and Canada [CAN]). Data will be collected retrospectively from medical charts.

No study medicines will be provided to participants in this study.

Full description

This study consists of two cohorts: Cohort 1 (resistant, refractory or intolerant to anti-CMV agents) includes participants who had an HSCT after January 1, 2016. Cohort 2 (pre-emptive treatment for CMV viremia) includes participants who had an HSCT after January 1, 2019. Participants who meet the criteria for both cohorts will be evaluated in each cohort separately (i.e., Cohort 1 and Cohort 2 are not mutually exclusive, and participants will be analyzed in both cohorts using unique index dates with respect to the cohort-specific eligibility criteria). Participant follow-up in the medical record must be available for at least one year from the CMV index date or death, whichever occurs first. The start date of data collection corresponds to the end of participant follow up. For Cohort 1, it is expected that follow up data will be available for up to 7 years (for those participants with an index date in 2016 and followed through 2022). For Cohort 2, it is expected that follow-up data will be available for up to 4 years (for those participants with an index date in 2019 and followed through 2022).

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

(Cohort 1) Resistant / Refractory or Intolerant:

• Aged greater than and equal to (>=) 18 years at the time of the HSCT.

• Received an HSCT after January 1, 2016.

• Diagnosed with CMV infection any time after the HSCT date.

• Required >=1 anti-CMV agent to manage CMV infection and were subsequently considered:

  1. resistant to currently available anti-CMV agent; OR
  2. refractory to currently available anti-CMV agent; OR
  3. intolerant to currently available anti-CMV agent.

• Follow-up information is available for at least 12 months from the index date (i.e., date when the participant was first considered resistant, refractory or intolerant to anti-CMV agent) or death, whichever occurs first.

• Provided written informed consent prior to the initiation of any study procedures (unless waiver was granted by Institutional Ethical Committee [IEC]).

(Cohort 2) Pre-emptive treatment for CMV viremia:

• Aged >=18 years at the time of the HSCT.
• Received an HSCT after January 1, 2019.
• Diagnosed with CMV viremia any time after the HSCT date and received pre-emptive anti-CMV agent.
• Follow-up information is available for at least 12 months from the index date (i.e., date when the patient was first preemptively treated with an anti-CMV agent) or death, whichever occurs first.
• Provided written informed consent prior to the initiation of any study procedures (unless waiver was granted by IEC).

Exclusion Criteria (both cohorts)

• Diagnosed as being positive for human immunodeficiency virus before the HSCT.
• Unable to demonstrate a minimum of 12 months of follow-up from the index date (e.g., incomplete information on dates showing follow-up time).
• Participation in a clinical trial related to CMV treatment during the study period.

Trial design

118 participants in 2 patient groups

Cohort 1: Resistant, Refractory, or Intolerant (RRI) to Anti-CMV treatment

Description:

Participants who had a HSCT after January 1, 2016, and developed post-transplant CMV infection were subsequently characterized as RRI to currently available anti-CMV treatment for at least 12 months before being enrolled, will be observed in this retrospective study for 24 months.

Cohort 2: Pre-emptive CMV Treatment

Description:

Participants who had a HSCT after January 1, 2019, were preemptively treated for CMV for at least 12 months before being enrolled, will be observed in this retrospective study for 24 months.