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

Recruiting

• Conditions: Cytomegalovirus (CMV)
• Interventions: Other: No Intervention

• Registration Number: NCT06213974
• Lead Sponsor: Takeda

Brief Summary

The main aim of this study is to learn about the safety of Maribavir in adults with post-transplant cytomegalovirus (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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Study First Posted: 2024-01-19
• Study Start: 2024-09-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-06-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adult participants (18 years or older) 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 that has been agreed with national regulatory authorities (ANMAT) as applicable.

Exclusion Criteria

• There are no specific exclusion criteria.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Participants	No Intervention	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	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 Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Clearance of Plasma Cytomegalovirus -Deoxyribonucleic Acid (CMV-DNA) (CMV Viremia Clearance) at End of Weeks 8 and 16	At Weeks 8 and 16	CMV viremia clearance will be defined as plasma CMV DNA concentration below the lower limit of quantification (\<LLOQ), assessed by each local laboratory, according to real-world clinical practice.
Percentage of Participants Who Achieved CMV Infection Symptom Control at End of Weeks 8 and 16	At Weeks 8 and 16	CMV infection symptom control will be defined as resolution or improvement of tissue invasive disease or CMV syndrome for symptomatic participants at baseline, or no new symptoms for asymptomatic participants at baseline.

Trial Locations

Locations (1)

IC Projects; 🇦🇷 City of Buenos Aires, Argentina