Cytomegalovirus (CMV)NCT06213974
A Study of Maribavir in Adults and Children With Post-transplant Cytomegalovirus (CMV) Infection in Argentina
An observational study of Cytomegalovirus (CMV), run by Takeda at 1 site in Argentina.
Trial summary
The main aim of this study is to learn about the safety of Maribavir in adults and children with post-transplant CMV infection in routine clinical practice in Argentina. The other aim is to study the effectiveness of the treatment with Maribavir in routine clinical practice in Argentina. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cytomegalovirus (CMV)
- How many people
- 28 participants
- Where
- 1 siteArgentina
- Study dates
- 3 Sep 2024to 17 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and pediatric participants with post-transplant CMV infection/disease that are refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet, that are treated with maribavir according to approved indications.
Who may be able to join
- Adult participants (18 years or older) and pediatric participants (12 years of age and older and weighing at least 35 kilogram [kg]) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet in the real-world setting of common clinical practice in Argentina.
- Have received at least one dose of maribavir according to approved indications.
- Have signed the mandatory informed consent/assent that has been agreed with national regulatory authorities (ANMAT) as applicable.
Who cannot join
- There are no specific exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Authorization Study to Monitor Efficacy, Effectiveness, and Safety of Maribavir (LIVTENCITY®) in Patients With Post-transplant Cytomegalovirus (CMV) Infection in Argentina
The main aim of this study is to learn about the safety of Maribavir in adults and children with post-transplant CMV infection in routine clinical practice in Argentina.
The other aim is to study the effectiveness of the treatment with Maribavir in routine clinical practice in Argentina.
Participants will be treated by their doctors according to normal medical practice. Study data will be collected either from information already available in the medical records or during study conduct.
- Conditions
- Cytomegalovirus (CMV)
- Being tested
- No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Participants who have received maribavir treatment for the approved indication after marketing authorization (de novo participants) and before marketing authorization (legacy participants) under expanded access type of program or compassionate use in the real-world setting. Data will be collected prospectively and/or retrospectively from the medical records during this observational period of 16 weeks. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. AEs will include both serious and non-serious AEs.
Measured: From start of treatment up to Week 16
Secondary outcomes (3)
Percentage of Participants Who Achieved Clearance of Plasma Cytomegalovirus -Deoxyribonucleic Acid (CMV-DNA) (CMV Viremia Clearance) at End of Weeks 8 and 16
CMV viremia clearance will be defined as CMV DNA concentration below the lower limit of considered by each local site for clearance according to real-world clinical practice.
Measured: At Weeks 8 and 16
Percentage of Participants Who Achieved CMV Infection Symptom Control at End of Weeks 8 and 16
CMV infection symptom control will be defined as resolution or improvement CMV disease/syndrome for participants symptomatic at baseline, or absence of the development of CMV disease/syndrome or participants asymptomatic at baseline.
Measured: At Weeks 8 and 16
Percentage of Participants Who Achieved a Clinically Relevant Response Regardless of Whether Treatment was Discontinued Before 8 weeks of Therapy
Clinically relevant response will be defined as no need for the use of an antiviral at a therapeutic dose for at least 4 weeks after completing treatment with maribavir, due to clinical improvement (improvement of CMV-related symptoms or the absence of these in the case of asymptomatic infections) and virological improvement (decrease of at least 1 log of viremia during treatment with maribavir).
Measured: Up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start3 Sep 2024
- Primary completion17 Jul 2026
- Study completion17 Jul 2026
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
- Other
- Enrolment
- 28 participants (actual)
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
- NCT06213974
- Sponsor's protocol ID
- TAK-620-4008
- Status last verified
- Aug 2026
- First submitted
- 10 Jan 2024
- Last updated
- 21 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Authorization Study to Monitor Efficacy, Effectiveness, and Safety of Maribavir (LIVTENCITY®) in Patients With Post-transplant Cytomegalovirus (CMV) Infection in Argentina
- ClinicalTrials.gov ID
- NCT06213974
- Acronym / sponsor ID
- TAK-620-4008
- Conditions
- Cytomegalovirus (CMV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 17 Jul 2026 (actual)
- Study completion
- 17 Jul 2026 (actual)
- First posted
- 19 Jan 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.
The main aim of this study is to learn about the safety of Maribavir in adults and children with post-transplant CMV infection in routine clinical practice in Argentina.
The other aim is to study the effectiveness of the treatment with Maribavir in routine clinical practice in Argentina.
Participants will be treated by their doctors according to normal medical practice. Study data will be collected either from information already available in the medical records or during study conduct.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: No InterventionParticipants who have received maribavir treatment for the approved indication after marketing authorization (de novo participants) and before marketing authorization (legacy participants) under expanded access type of program or compassionate use in the real-world setting. Data will be collected prospectively and/or retrospectively from the medical records during this observational period of 16 weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric participants with post-transplant CMV infection/disease that are refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet, that are treated with maribavir according to approved indications.
Key inclusion criteria (3 listed)
- Adult participants (18 years or older) and pediatric participants (12 years of age and older and weighing at least 35 kilogram [kg]) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet in the real-world setting of common clinical practice in Argentina.
- Have received at least one dose of maribavir according to approved indications.
- Have signed the mandatory informed consent/assent that has been agreed with national regulatory authorities (ANMAT) as applicable.
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria.
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 |
|---|---|---|
| No InterventionThis is non-interventional study. | Other | All Participants |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: From start of treatment up to Week 16
An AE is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. AEs will include both serious and non-serious AEs.
3 secondary outcomes
Percentage of Participants Who Achieved Clearance of Plasma Cytomegalovirus -Deoxyribonucleic Acid (CMV-DNA) (CMV Viremia Clearance) at End of Weeks 8 and 16
Time frame: At Weeks 8 and 16
Percentage of Participants Who Achieved CMV Infection Symptom Control at End of Weeks 8 and 16
Time frame: At Weeks 8 and 16
Percentage of Participants Who Achieved a Clinically Relevant Response Regardless of Whether Treatment was Discontinued Before 8 weeks of Therapy
Time frame: Up to Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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.
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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. This study is not recruiting at the moment.
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 Argentina.
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 3 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: finished, as of the sponsor's last update on 21 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 Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: From start of treatment up to Week 16). 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 21 Aug 2026.