Evaluating LIVTENCITY for treating CMV infection in transplant patients in South Korea
Post-Marketing Surveillance (Usage Results Study) of LIVTENCITY Tablet (Maribavir) for the Approved Indications in South Korea
This study is testing if LIVTENCITY can safely and effectively treat cytomegalovirus (CMV) infection in adults who have had a transplant and haven't had success with other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 168 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06555432 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and effectiveness of LIVTENCITY (Maribavir) in adults suffering from cytomegalovirus (CMV) infection following transplantation. Participants will have their data collected over approximately 20 weeks, with recommended visits to the study doctor around six times during this period. The study focuses on individuals who have had prior treatments for CMV that were ineffective or not tolerated. The goal is to understand how LIVTENCITY performs in a real-world clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with post-transplant CMV infection who have not responded to previous therapies.
Not a fit: Patients for whom LIVTENCITY is contraindicated or those who have previously been treated with it will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for adults with CMV infection after transplantation.
How similar studies have performed: Other studies have shown promising results with similar antiviral approaches, but this specific application of LIVTENCITY in post-transplant CMV infection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Seoul
- The Catholic University of Korea, Seoul ST. Mary's Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.