CompletedPhase 3

A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection

Japan41 participantsStarted 2022-01-18

Plain-language summary

The main aim of the study is to check if maribavir can treat Japanese people with Cytomegalovirus (CMV) infection, and to check side effect from the study treatment and how much maribavir participants can take without getting side effects from it. Japanese recipients of a hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) will take Maribavir tablets two times a day for 8 weeks in this study. During the study, participants will visit their study clinic 18 times as a maximum.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Be Japanese with Japanese nationality, \>=16 years of age at the time of consent.
. Be a recipient of HSCT or SOT that is functioning at the time of Screening.
. Have a documented CMV infection with a screening value of \>455 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by a central specialty laboratory qPCR or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to first dose of study treatment with the second sample obtained within 5 days prior to first dose of study treatment at Visit 2/Day 0.
. Have the current CMV infection after HSCT or SOT, either primary or reactivation, which, in the investigator's opinion, requires treatment and have any of the following.
. Asymptomatic participants: The subjects do not have CMV tissue-invasive disease or CMV syndrome (SOT subjects only) at Baseline, as determined by the investigator according to the criteria specified by Ljungman et al., 2017.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) at Week 8

Timeframe: At Week 8

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

Timeframe: From first dose of study drug up to Week 20

Number of Participants With TEAEs Leading to Treatment Discontinuation With Maribavir

Timeframe: From first dose of study drug up to Week 20

Number of Participants With Clinically Meaningful Changes in Vital Signs

Timeframe: From first dose of study drug up to Week 20

Number of Participants With Clinically Meaningful Abnormalities in Physical Examination Findings

Timeframe: From first dose of study drug up to Week 20

Number of Participants With Clinically Meaningful Abnormalities in Clinical Laboratory Parameters

Timeframe: From first dose of study drug up to Week 20

Trial details

NCT IDNCT05137717

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-27

Results submitted2024-06-07

View on ClinicalTrials.gov More Cytomegalovirus (CMV) trials

Plain-language summary

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Be Japanese with Japanese nationality, \>=16 years of age at the time of consent.
. Be a recipient of HSCT or SOT that is functioning at the time of Screening.
. Have a documented CMV infection with a screening value of \>455 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by a central specialty laboratory qPCR or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to first dose of study treatment with the second sample obtained within 5 days prior to first dose of study treatment at Visit 2/Day 0.
. Have the current CMV infection after HSCT or SOT, either primary or reactivation, which, in the investigator's opinion, requires treatment and have any of the following.
. Asymptomatic participants: The subjects do not have CMV tissue-invasive disease or CMV syndrome (SOT subjects only) at Baseline, as determined by the investigator according to the criteria specified by Ljungman et al., 2017.

What they're measuring

Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) at Week 8

Timeframe: At Week 8

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

Timeframe: From first dose of study drug up to Week 20

Number of Participants With TEAEs Leading to Treatment Discontinuation With Maribavir

Timeframe: From first dose of study drug up to Week 20

Number of Participants With Clinically Meaningful Changes in Vital Signs

Timeframe: From first dose of study drug up to Week 20

Number of Participants With Clinically Meaningful Abnormalities in Physical Examination Findings

Timeframe: From first dose of study drug up to Week 20

Number of Participants With Clinically Meaningful Abnormalities in Clinical Laboratory Parameters

Timeframe: From first dose of study drug up to Week 20

A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria