A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection

Not yet recruiting

• Conditions: Cytomegalovirus (CMV)
• Interventions: Drug: Maribavir

• Registration Number: NCT06577363
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study Start: 2024-08-28
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Primary Completion: 2031-08-30
• Study Completion: 2031-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs)	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 Outcome Measures

Name	Time	Method
Percentage of Participants With All-cause Mortality by the End of the Study	27 weeks	Percentage of participants who died during the entire study period will be reported.
Percentage of Participants With Graft Rejection	27 weeks	Percentage of participants With TEAEs of graft rejection will be reported.
Percentage of Participants With Confirmed CMV viremia Clearance	27 weeks	Confirmed CMV viremia clearance will be assessed based on plasma CMV DNA concentration in plasma or CMV positive antigen cell in blood.
Percentage of Participants Who Have a Response to CMV, as Assessed by the Investigator	27 weeks	Percentage of participants who have a response to CMV, as assessed by the investigator will be reported.
Percentage of Participants With Resistance to Maribavir Treatment	27 weeks	Based on treatment and observation in clinical practice, incidence of CMV resistance to this drug is evaluated.
Percentage of Participants With Graft-versus-host Disease (GVHD)	27 weeks	Percentage of participants with TEAEs of GVHD will be reported.

Trial Locations

Locations (1)

Takeda selected site; 🇯🇵 Tokyo, Japan