A Study of Maribavir in Adults and Children With Post-transplant Cytomegalovirus (CMV) Infection in Argentina

NCT ID: NCT06213974

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-03

Study Completion Date

2026-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cytomegalovirus (CMV)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No Intervention

Intervention Type OTHER

This is non-interventional study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No Intervention

This is non-interventional study.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IC Projects

City of Buenos Aires, , Argentina

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Argentina

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Takeda Contact

Role: CONTACT

+1-877-825-3327

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Role: primary

(54911)-4076-7468

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TAK-620-4008

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.