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NCT Number: NCT06577363

A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection

This study is a survey in Japan of Maribavir tablets used to treat participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation).

The main aim of the study is to check if treatment with Maribavir can protect Japanese people against CMV infection, and to check side effect from the study treatment. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants with CMV infection will take Maribavir tablets according to their clinic's standard practice. The study doctors will check for side effects from Maribavir tablets for 27 weeks.

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Key information

Conditions

Cytomegalovirus (CMV)

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda selected site

Tokyo, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation).

Exclusion criteria

  • None

Treatment and study plan

Maribavir

Drug

Maribavir tablets

Primary outcomes

  1. Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs)

    Time frame: Up to 27 weeks

    An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. Adverse drug reaction refers (ADR) to AE related to administered drug.

Secondary outcomes

  1. Percentage of Participants With Confirmed CMV viremia Clearance

    Time frame: 27 weeks

    Confirmed CMV viremia clearance will be assessed based on plasma CMV DNA concentration in plasma or CMV positive antigen cell in blood.

  2. Percentage of Participants Who Have a Response to CMV, as Assessed by the Investigator

    Time frame: 27 weeks

    Percentage of participants who have a response to CMV, as assessed by the investigator will be reported.

  3. Percentage of Participants With Resistance to Maribavir Treatment

    Time frame: 27 weeks

    Based on treatment and observation in clinical practice, incidence of CMV resistance to this drug is evaluated.

  4. Percentage of Participants With Graft Rejection

    Time frame: 27 weeks

    Percentage of participants With TEAEs of graft rejection will be reported.

  5. Percentage of Participants With Graft-versus-host Disease (GVHD)

    Time frame: 27 weeks

    Percentage of participants with TEAEs of GVHD will be reported.

  6. Percentage of Participants With All-cause Mortality by the End of the Study

    Time frame: 27 weeks

    Percentage of participants who died during the entire study period will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Special Drug Use Surveillance of LIVTENCITY Tablets 200mg (All-Case Investigation)

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Aug 29, 2024
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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