A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection

NCT06577363 | Recruiting

• 2 other identifiers: TAK-620-4013jRCT2031240302
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cytomegalovirus (CMV)

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 27 weeks

Secondary Outcomes (6)

• Percentage of Participants With Confirmed CMV viremia Clearance

  27 weeks

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

  27 weeks

• Percentage of Participants With Resistance to Maribavir Treatment

  27 weeks

• Percentage of Participants With Graft Rejection

  27 weeks

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

  27 weeks

Study Arms (1)

Maribavir

Maribavir 400 milligrams (mg), tablets, orally twice a day.

Drug: Maribavir

Interventions

Maribavir DRUG

Maribavir tablets

Maribavir

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population of this survey are all participants who meet the inclusion/exclusion criteria.

You may qualify if:

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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda selected site

Tokyo, Japan

RECRUITING

MeSH Terms

Interventions

maribavir

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: August 28, 2024
• Primary Completion (Estimated): August 30, 2031
• Study Completion (Estimated): August 30, 2031
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (1)