Cytomegalovirus (CMV)NCT06577363
A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection
An observational study of Cytomegalovirus (CMV), run by Takeda at 1 site in Japan.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cytomegalovirus (CMV)
- What is being tested?
- Maribavir
- Type of treatment
- Pill or oral medicine
- How many people
- 250 participants
- Where
- 1 siteJapan
- Study dates
- 28 Aug 2024to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.
Who may be able to join
- All participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Special Drug Use Surveillance of LIVTENCITY Tablets 200mg (All-Case Investigation)
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)
- Being tested
- Maribavir
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaribavirDrug
Maribavir tablets
| Study group | Role | What they receive |
|---|---|---|
| Maribavir | Maribavir 400 milligrams (mg), tablets, orally twice a day. Receives: Drug: Maribavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 27 weeks
Secondary outcomes (6)
Percentage of Participants With Confirmed CMV viremia Clearance
Confirmed CMV viremia clearance will be assessed based on plasma CMV DNA concentration in plasma or CMV positive antigen cell in blood.
Measured: 27 weeks
Percentage of Participants Who Have a Response to CMV, as Assessed by the Investigator
Percentage of participants who have a response to CMV, as assessed by the investigator will be reported.
Measured: 27 weeks
Percentage of Participants With Resistance to Maribavir Treatment
Based on treatment and observation in clinical practice, incidence of CMV resistance to this drug is evaluated.
Measured: 27 weeks
Percentage of Participants With Graft Rejection
Percentage of participants With TEAEs of graft rejection will be reported.
Measured: 27 weeks
Percentage of Participants With Graft-versus-host Disease (GVHD)
Percentage of participants with TEAEs of GVHD will be reported.
Measured: 27 weeks
Percentage of Participants With All-cause Mortality by the End of the Study
Percentage of participants who died during the entire study period will be reported.
Measured: 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start28 Aug 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus (CMV)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577363
- Sponsor's protocol ID
- TAK-620-4013
- Other IDs
- jRCT2031240302
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Surveillance of LIVTENCITY Tablets 200mg (All-Case Investigation)
- ClinicalTrials.gov ID
- NCT06577363
- Acronym / sponsor ID
- TAK-620-4013
- Conditions
- Cytomegalovirus (CMV)
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maribavir | – | Drug: MaribavirMaribavir 400 milligrams (mg), tablets, orally twice a day. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population of this survey are all participants who meet the inclusion/exclusion criteria.
Key inclusion criteria (1 listed)
- All participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaribavirMaribavir tablets | Drug | Maribavir |
Primary outcome
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.
6 secondary outcomes
Percentage of Participants With Confirmed CMV viremia Clearance
Time frame: 27 weeks
Percentage of Participants Who Have a Response to CMV, as Assessed by the Investigator
Time frame: 27 weeks
Percentage of Participants With Resistance to Maribavir Treatment
Time frame: 27 weeks
Percentage of Participants With Graft Rejection
Time frame: 27 weeks
Percentage of Participants With Graft-versus-host Disease (GVHD)
Time frame: 27 weeks
Percentage of Participants With All-cause Mortality by the End of the Study
Time frame: 27 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Related trials for Cytomegalovirus (CMV)
RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 3
Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
Cytomegalovirus (CMV), Kidney Transplant; Complications
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus (CMV), run by Takeda at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs) (time frame: Up to 27 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.