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NCT Number: NCT06213974

A Study of Maribavir in Adults and Children 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.

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Key information

Conditions

Cytomegalovirus (CMV)

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IC Projects

City of Buenos Aires, C11119ACN, Argentina

Location status: Recruiting

Location contact

Raul Bozzo

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

(54911)-4076-7468

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • There are no specific exclusion criteria.

Treatment and study plan

No intervention

Other

This is non-interventional study.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Percentage of Participants Who Achieved CMV Infection Symptom Control at End of Weeks 8 and 16

    Time frame: At 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.

  3. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Post Authorization Study to Monitor Efficacy, Effectiveness, and Safety of Maribavir (LIVTENCITY®) in Patients With Post-transplant Cytomegalovirus (CMV) Infection in Argentina

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 19, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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