A Survey of Maribavir tablets in Participants with Cytomegalovirus Infection

JRCT ID: jRCT2031240302

Registered date:28/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cytomegalovirus (CMV) infection
• Date of first enrollment: 28/08/2024
• Target sample size: 250
• Study type: Observational

Outcome(s)

Primary Outcome

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 (ADR) refers to AE related to administered drug.

Secondary Outcome

1.Percentage of Participants With Confirmed CMV Viremia Clearance
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 27 weeks
Percentage of participants With TEAEs of graft rejection will be reported.

5.Percentage of Participants With Graft-versus-host Disease (GVHD)
Timeframe: 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
Timeframe: 27 weeks
Percentage of participants who died during the entire study period will be reported.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 1.All participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation).
• Exclude criteria: None

Related Information

• Primary Sponsor: Contact for Clinical Trial Information
• Secondary ID(s): NCT06577363