A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection

Takeda

Status: Enrolling

Conditions: Cytomegalovirus (CMV)

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06615921

TAK-620-5010

Details and patient eligibility

About

The main aim of this study is to check how effective the treatment with Maribavir has been to remove the CMV viruses from the blood of an adult person with CMV infection after a transplant. Other aims are to learn more about how maribavir is used in normal clinical routine, study the profiles of adults treated with maribavir, and what other treatments have been given, and describe healthcare resources used for CMV management.

Only data already available in the medical records of the participants will be reviewed and collected during this study.

Full description

This study will include two main periods of retrospective data collection from medical charts: the pre-index period and the post-index period. The index date is defined as the date of initiation of maribavir dosing, as documented in the medical records. The pre-index period covers the time from the transplant date to the index event, while the post-index period starts at the index event and ends at the date of chart abstraction, death, or loss to follow-up, whichever comes first.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged greater than or equal to (>=) 18 years at the time of consent or start of chart abstraction in case a consent waiver will be allowed as per local regulation.
• Received an HSCT/SOT.
• Diagnosed with CMV infection/disease any time after the HSCT/SOT date.
• Initiated maribavir at least 4 months before the chart abstraction date (or at time of Central Ethics Committee [CEC]/Local Ethics Committee [LEC] submission as per local regulation).
• Participants with hospital medical chart available, who signed an informed consent form before starting any study procedures (unless waiver is allowed as per local regulation).

Exclusion criteria

• Participants who do not provide informed consent, where consent is required per country regulations.
• Participants who participated to Clinical Trials investigating maribavir.

Trial design

150 participants in 2 patient groups

Participants With CMV Infection Refractory

Description:

Participants who had a CMV infection/disease that is refractory to treatment (with or without resistance). Data will be retrospectively collected from date of solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT) up to the start date of chart abstraction, death or loss to follow-up, whichever comes first. Participants will be considered as refractory if they show no change or increased viremia after at least 2 weeks of appropriately dosed antiviral therapy.

Treatment:

Other: No Intervention

Participants With CMV Infection Intolerant

Description:

Participants with CMV infection intolerant to anti-CMV treatment. Data will be retrospectively collected from date of SOT/HSCT up to the start date of chart abstraction, death or loss to follow-up, whichever comes first. Intolerant participants identified based on physician judgment.

Treatment:

Other: No Intervention