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

Cytomegalovirus (CMV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06213974
• Other study ID #: TAK-620-4008
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: January 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cytomegalovirus (CMV)
• Cytomegalovirus Infections

Intervention

Other:
• No Intervention
This is non-interventional study.

Locations

Country	Name	City	State
Argentina	IC Projects	City of Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From start of treatment up to Week 16
Secondary	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 plasma CMV DNA concentration below the lower limit of quantification (	At Weeks 8 and 16
Secondary	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 of tissue invasive disease or CMV syndrome for symptomatic participants at baseline, or no new symptoms for asymptomatic participants at baseline.	At Weeks 8 and 16