Survey of Maribavir tablets for treating Cytomegalovirus infection
Special Drug Use Surveillance of LIVTENCITY Tablets 200mg (All-Case Investigation)
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Trial ID | NCT06577363 on ClinicalTrials.gov |
What this trial studies
This observational study surveys the use of Maribavir tablets in Japanese participants suffering from Cytomegalovirus (CMV) infection that is resistant to existing anti-CMV therapies, particularly in the context of organ transplantation. Participants will take Maribavir according to their clinic's standard practices, and the study will monitor any side effects over a period of 27 weeks. The study aims to evaluate the effectiveness of Maribavir in protecting against CMV infection and to gather data on its safety profile.
Who should consider this trial
Good fit: Ideal candidates are individuals with Cytomegalovirus infection that is refractory to current anti-CMV therapies, particularly those who have undergone organ transplantation.
Not a fit: Patients who do not have Cytomegalovirus infection or those who are not refractory to existing treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with resistant CMV infections.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in using Maribavir for CMV infections, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- All participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation). Exclusion Criteria: \- None
Where this trial is running
Tokyo
- Takeda selected site — Tokyo, Japan (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.