Cytomegalovirus (CMV)NCT06555432
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
An observational study of Cytomegalovirus (CMV), run by Takeda at 1 site in South Korea.
Trial summary
Cytomegalovirus (CMV) is a common virus that infects many people. It can cause serious illness in people with weak immune systems especially in those undergoing transplants. LIVTENCITY (Maribavir) is a medicine approved for treating CMV infection in adults after transplant in South Korea. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cytomegalovirus (CMV)
- What is being tested?
- LIVTENCITY
- Type of treatment
- Pill or oral medicine
- How many people
- 168 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Nov 2024to 1 Oct 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy including ganciclovir, valganciclovir, foscarnet or cidofovir and initiate maribavir treatment for the first time will be enrolled.
Who may be able to join
- Participants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy including ganciclovir, valganciclovir, cidofovir or foscarnet.
- Participants with age greater than or equal to (>=) 19 years.
- Initiate first treatment course with maribavir.
- Voluntarily consent to participate in the study.
Who cannot join
- Participants for whom LIVTENCITY Tablet (maribavir) is contraindicated as per product label.
- Participants previously treated with maribavir in any study or as marketed drug.
- Participants actively participating in other clinical trials of post-transplant CMV infection treatment or with other experimental treatments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, 06591
Site Contact, cho.sy@catholic.ac.kr
Cho Seong-yeon
About this study
Official title: Post-Marketing Surveillance (Usage Results Study) of LIVTENCITY Tablet (Maribavir) for the Approved Indications in South Korea
Cytomegalovirus (CMV) is a common virus that infects many people. It can cause serious illness in people with weak immune systems especially in those undergoing transplants. LIVTENCITY (Maribavir) is a medicine approved for treating CMV infection in adults after transplant in South Korea.
The main aim of this study is to learn how safe and effective LIVTENCITY (Maribavir) is in treating adults with CMV infection after transplant in a routine clinical practice setting.
During the study, a participant's data will be collected for about 5 months (20 weeks). The study does not have fixed visits to the hospital, but it is recommended to visit the study doctor approximately 6 times during study.
- Conditions
- Cytomegalovirus (CMV)
- Being tested
- LIVTENCITY
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIVTENCITYDrug
Also called Maribavir
LIVTENCITY tablet.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Participants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy (including ganciclovir, valganciclovir, foscarnet or cidofovir) will be treated with LIVTENCITY tablet as per treating physician's discretion in a routine clinical practice setting, according to the approved labelling and will be observed prospectively for up to a 20-week period. Receives: Drug: LIVTENCITY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)
Number of participants with AEs, causality to AEs, SAEs and AESI will be reported. The investigator will assess the causal relationship (causality) between the medicinal product and the AE using his/her clinical expertise and judgment.
Measured: Up to Week 20
Number of Participants With Expected/Unexpected AEs and SAEs
Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome.
Measured: Up to Week 20
Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Expected ADRs, Serious ADRs (SADRs) Expected SADRs and Unexpected SADRs
An ADR refers to a harmful and unintended reaction that occurs when an investigational product is normally administered or used, and when the causal relationship between the reaction and the investigational product cannot be ruled out. Among voluntarily reported AEs, if the causality between the AE and the investigational product is not known, it is considered an ADR. However, if both the reporter and the manufacturer/sponsor determine that the case is unrelated to the investigational product, it is excluded from being classified as an ADR. Serious ADR means noxious or unintended response to a drug that occurs at any dosage and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Unexpected ADRs is defined as ADR that differs from the information in the product label in nature, severity, specificity, or outcome.
Measured: Up to Week 20
Number of Participants With Special Situation Report (SSR)
SSR include following events: Pregnancy: any case in which a pregnancy participant is exposed to a Takeda Product or in which a female participant or partner of a male participant becomes pregnant following Takeda product.; Breastfeeding: infant exposure from breast milk; Overdose: all information of any accidental or intentional overdose; Drug abuse, misuse or medication error: all information on medicinal product (MP) abuse, misuse of medication error (potential or actual); Suspected transmission of infectious agent: Suspected (in sense of confirmed or potential) transmission of infectious agent by a MP; Lack of efficacy of Takeda Product; accidental/occupational exposure; Use outside the terms of the marketing authorization, also known as "off-label" and "off-label use" for unintended benefit; Use of falsified and counterfeit MP; Drug-drug and drug-food interactions; Inadvertent or accidental exposure with or without an AE; AEs occurring in the pediatric or elderly population.
Measured: Up to Week 20
Secondary outcomes (2)
Percentage of Participants With CMV Viremia Clearance as Assessed by Polymerase Chain Reaction (PCR)
CMV viremia clearance will be defined as CMV deoxyribonucleic acid (DNA) concentration below the lower limit of quantification (<LLOQ) or predefined threshold of each device. The assessment will be done using PCR.
Measured: At Weeks 2, 8 and the last dose (up to 20 weeks)
Percentage of Participants Who Achieved CMV Infection Symptom Control
CMV infection symptom control will be defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline or no symptoms of tissue invasive CMV disease or CMV syndrome for subjects asymptomatic at baseline.
Measured: At Weeks 2, 8 and the last dose (up to 20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start14 Nov 2024
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 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
- 168 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
- NCT06555432
- Sponsor's protocol ID
- TAK-620-4002
- Status last verified
- Nov 2026
- First submitted
- 13 Aug 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance (Usage Results Study) of LIVTENCITY Tablet (Maribavir) for the Approved Indications in South Korea
- ClinicalTrials.gov ID
- NCT06555432
- Acronym / sponsor ID
- TAK-620-4002
- Conditions
- Cytomegalovirus (CMV)
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 15 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.
Cytomegalovirus (CMV) is a common virus that infects many people. It can cause serious illness in people with weak immune systems especially in those undergoing transplants. LIVTENCITY (Maribavir) is a medicine approved for treating CMV infection in adults after transplant in South Korea.
The main aim of this study is to learn how safe and effective LIVTENCITY (Maribavir) is in treating adults with CMV infection after transplant in a routine clinical practice setting.
During the study, a participant's data will be collected for about 5 months (20 weeks). The study does not have fixed visits to the hospital, but it is recommended to visit the study doctor approximately 6 times during study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Drug: LIVTENCITYParticipants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy (including ganciclovir, valganciclovir, foscarnet or cidofovir) will be treated with LIVTENCITY tablet as per treating physician's discretion in a routine clinical practice setting, according to the approved labelling and will be observed prospectively for up to a 20-week period. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy including ganciclovir, valganciclovir, foscarnet or cidofovir and initiate maribavir treatment for the first time will be enrolled.
Key inclusion criteria (4 listed)
- Participants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy including ganciclovir, valganciclovir, cidofovir or foscarnet.
- Participants with age greater than or equal to (>=) 19 years.
- Initiate first treatment course with maribavir.
- Voluntarily consent to participate in the study.
Key exclusion criteria (3 listed)
- Participants for whom LIVTENCITY Tablet (maribavir) is contraindicated as per product label.
- Participants previously treated with maribavir in any study or as marketed drug.
- Participants actively participating in other clinical trials of post-transplant CMV infection treatment or with other experimental treatments.
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 |
|---|---|---|
| LIVTENCITYAlso: MaribavirLIVTENCITY tablet. | Drug | All Participants |
Primary outcome
Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)
Time frame: Up to Week 20
Number of participants with AEs, causality to AEs, SAEs and AESI will be reported. The investigator will assess the causal relationship (causality) between the medicinal product and the AE using his/her clinical expertise and judgment.
Number of Participants With Expected/Unexpected AEs and SAEs
Time frame: Up to Week 20
Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome.
Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Expected ADRs, Serious ADRs (SADRs) Expected SADRs and Unexpected SADRs
Time frame: Up to Week 20
An ADR refers to a harmful and unintended reaction that occurs when an investigational product is normally administered or used, and when the causal relationship between the reaction and the investigational product cannot be ruled out. Among voluntarily reported AEs, if the causality between the AE and the investigational product is not known, it is considered an ADR. However, if both the reporter and the manufacturer/sponsor determine that the case is unrelated to the investigational product, it is excluded from being classified as an ADR. Serious ADR means noxious or unintended response to a drug that occurs at any dosage and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Unexpected ADRs is defined as ADR that differs from the information in the product label in nature, severity, specificity, or outcome.
Number of Participants With Special Situation Report (SSR)
Time frame: Up to Week 20
SSR include following events: Pregnancy: any case in which a pregnancy participant is exposed to a Takeda Product or in which a female participant or partner of a male participant becomes pregnant following Takeda product.; Breastfeeding: infant exposure from breast milk; Overdose: all information of any accidental or intentional overdose; Drug abuse, misuse or medication error: all information on medicinal product (MP) abuse, misuse of medication error (potential or actual); Suspected transmission of infectious agent: Suspected (in sense of confirmed or potential) transmission of infectious agent by a MP; Lack of efficacy of Takeda Product; accidental/occupational exposure; Use outside the terms of the marketing authorization, also known as "off-label" and "off-label use" for unintended benefit; Use of falsified and counterfeit MP; Drug-drug and drug-food interactions; Inadvertent or accidental exposure with or without an AE; AEs occurring in the pediatric or elderly population.
2 secondary outcomes
Percentage of Participants With CMV Viremia Clearance as Assessed by Polymerase Chain Reaction (PCR)
Time frame: At Weeks 2, 8 and the last dose (up to 20 weeks)
Percentage of Participants Who Achieved CMV Infection Symptom Control
Time frame: At Weeks 2, 8 and the last dose (up to 20 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 6 Nov 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
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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 South Korea.
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 4 inclusion and 3 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 6 Nov 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 South Korea. 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 With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI) (time frame: Up to Week 20). The study lists 4 primary outcomes in all. 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 6 Nov 2026.