Evaluating LIVTENCITY for treating CMV infection in transplant patients in South Korea
Official title: Post-Marketing Surveillance (Usage Results Study) of LIVTENCITY Tablet (Maribavir) for the Approved Indications in South Korea
Run by Takeda · NCT06555432 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 168 (estimated) |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | November 14, 2024 |
| Main results expected | October 1, 2028 |
| Study ends | October 1, 2028 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT06555432 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 19 and older with post-transplant CMV infection who have not responded to previous therapies.
✕Probably not a fit
Patients for whom LIVTENCITY is contraindicated or those who have previously been treated with it will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with similar antiviral approaches, but this specific application of LIVTENCITY in post-transplant CMV infection is relatively novel.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Maribavir for CMV in people with lymphoma or multiple myeloma receiving bispecific antibodies
This will test whether the oral antiviral maribavir can treat CMV reactivation in adults with lymphoma or multiple myeloma who are receiving bispecific antibody therapy.
-
Preventing CMV after receiving a CMV-positive donor kidney using daily antiviral pills or weekly blood monitoring
This study will test whether taking daily antiviral pills for 200 days or doing weekly blood checks and treating only if the virus appears is better at preventing CMV disease in adults who get a kidney from a CMV-positive donor and are themselves CMV-negative.
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Comparing tests for diagnosing cytomegalovirus in patients with inflammatory bowel disease
This study is testing different ways to diagnose cytomegalovirus in adults with inflammatory bowel disease who are having worse symptoms and need to be hospitalized.
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Survey of Maribavir tablets for treating Cytomegalovirus infection
This study is testing if Maribavir tablets can help people with Cytomegalovirus infection who haven't responded to other treatments, especially those who have had an organ transplant.
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Maribavir for CMV in adults with kidney failure after transplantation
This project will see if maribavir is safe for adults with severe kidney failure (including people on dialysis) who develop CMV after a transplant by reviewing existing medical records.
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Maribavir treatment for CMV infection in children and adolescents after stem cell or organ transplant
This study tests whether maribavir is safe and works to treat CMV infection in children and teenagers who have had a stem cell or solid organ transplant.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.