A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea

NCT06555432 | Recruiting FDA Drug

• 1 other identifier: TAK-620-4002
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Cytomegalovirus (CMV) is a common virus that infects many people. It can cause serious illness in people with weak immune systems especially in those undergoing transplants. LIVTENCITY (Maribavir) is a medicine approved for treating CMV infection in adults after transplant in South Korea. The main aim of this study is to learn how safe and effective LIVTENCITY (Maribavir) is in treating adults with CMV infection after transplant in a routine clinical practice setting. During the study, a participant's data will be collected for about 5 months (20 weeks). The study does not have fixed visits to the hospital, but it is recommended to visit the study doctor approximately 6 times during study.

Conditions

Cytomegalovirus (CMV)

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)

  Number of participants with AEs, causality to AEs, SAEs and AESI will be reported. The investigator will assess the causal relationship (causality) between the medicinal product and the AE using his/her clinical expertise and judgment.

  Up to Week 20

• Number of Participants With Expected/Unexpected AEs and SAEs

  Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome.

  Up to Week 20

• Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Expected ADRs, Serious ADRs (SADRs) Expected SADRs and Unexpected SADRs

  An ADR refers to a harmful and unintended reaction that occurs when an investigational product is normally administered or used, and when the causal relationship between the reaction and the investigational product cannot be ruled out. Among voluntarily reported AEs, if the causality between the AE and the investigational product is not known, it is considered an ADR. However, if both the reporter and the manufacturer/sponsor determine that the case is unrelated to the investigational product, it is excluded from being classified as an ADR. Serious ADR means noxious or unintended response to a drug that occurs at any dosage and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Unexpected ADRs is defined as ADR that differs from the information in the product label in nature, severity, specificity, or outcome.

  Up to Week 20

• Number of Participants With Special Situation Report (SSR)

  SSR include following events: Pregnancy: any case in which a pregnancy participant is exposed to a Takeda Product or in which a female participant or partner of a male participant becomes pregnant following Takeda product.; Breastfeeding: infant exposure from breast milk; Overdose: all information of any accidental or intentional overdose; Drug abuse, misuse or medication error: all information on medicinal product (MP) abuse, misuse of medication error (potential or actual); Suspected transmission of infectious agent: Suspected (in sense of confirmed or potential) transmission of infectious agent by a MP; Lack of efficacy of Takeda Product; accidental/occupational exposure; Use outside the terms of the marketing authorization, also known as "off-label" and "off-label use" for unintended benefit; Use of falsified and counterfeit MP; Drug-drug and drug-food interactions; Inadvertent or accidental exposure with or without an AE; AEs occurring in the pediatric or elderly population.

  Up to Week 20

Secondary Outcomes (2)

• Percentage of Participants With CMV Viremia Clearance as Assessed by Polymerase Chain Reaction (PCR)

  At Weeks 2, 8 and the last dose (up to 20 weeks)

• Percentage of Participants Who Achieved CMV Infection Symptom Control

  At Weeks 2, 8 and the last dose (up to 20 weeks)

Study Arms (1)

All Participants

Participants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy (including ganciclovir, valganciclovir, foscarnet or cidofovir) will be treated with LIVTENCITY tablet as per treating physician's discretion in a routine clinical practice setting, according to the approved labelling and will be observed prospectively for up to a 20-week period.

Drug: LIVTENCITY

Interventions

LIVTENCITY DRUG

LIVTENCITY tablet.

Also known as: Maribavir

All Participants

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy including ganciclovir, valganciclovir, foscarnet or cidofovir and initiate maribavir treatment for the first time will be enrolled.

You may qualify if:

• Participants with post-transplant CMV infection and/or disease who are refractory and/or resistant to one or more prior therapy including ganciclovir, valganciclovir, cidofovir or foscarnet.
• Participants with age greater than or equal to (\>=) 19 years.
• Initiate first treatment course with maribavir.
• Voluntarily consent to participate in the study.

You may not qualify if:

• Participants for whom LIVTENCITY Tablet (maribavir) is contraindicated as per product label.
• Participants previously treated with maribavir in any study or as marketed drug.
• Participants actively participating in other clinical trials of post-transplant CMV infection treatment or with other experimental treatments.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Interventions

maribavir

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

KR (1)