Evaluating Maribavir for Cytomegalovirus Infection in Adults After Transplant
A Multi-country, Multi-center, Retrospective Chart Review to Describe the Use of Maribavir and Its Effectiveness in Patients With Post-Transplant Cytomegalovirus Infection/Disease
This study is testing if Maribavir can help adults who have had a transplant get rid of Cytomegalovirus from their blood.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 45 sites (Vienna and 44 other locations) |
| Trial ID | NCT06615921 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of Maribavir in eliminating Cytomegalovirus (CMV) from the bloodstream of adults who have undergone a transplant. It involves retrospective data collection from medical records, focusing on two periods: before and after the initiation of Maribavir treatment. The study will analyze patient profiles, treatment history, and healthcare resources utilized for managing CMV infections. The data collected will help understand the real-world application of Maribavir in clinical settings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have received a hematopoietic stem cell transplant or solid organ transplant and have been diagnosed with CMV infection.
Not a fit: Patients who have not consented to participate or those involved in other clinical trials investigating Maribavir may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective management strategies for CMV infections in post-transplant patients.
How similar studies have performed: Previous studies have shown promise in using Maribavir for CMV treatment, indicating potential for success in this observational approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Aged greater than or equal to (\>=) 18 years at the time of consent or start of chart abstraction in case a consent waiver will be allowed as per local regulation. * Received an HSCT/SOT. * Diagnosed with CMV infection/disease any time after the HSCT/SOT date. * Initiated maribavir at least 4 months before the chart abstraction date (or at time of Central Ethics Committee \[CEC\]/Local Ethics Committee \[LEC\] submission as per local regulation). * Participants with hospital medical chart available, who signed an informed consent form before starting any study procedures (unless waiver is allowed as per local regulation). Exclusion criteria: * Participants who do not provide informed consent, where consent is required per country regulations. * Participants who participated to Clinical Trials investigating maribavir.
Where this trial is running
Vienna and 44 other locations
- Medical University of Vienna Dept. of Nephrology and Dialysis — Vienna, Austria (Recruiting)
- Copenhagen University Hospital, Rigshospitalet — Copenaghen, Denmark (Not_yet_recruiting)
- Groupe Hospitalier Pellegrin - CHU BORDEAUX — Bordeaux, France (Not_yet_recruiting)
- Department of Nephrology, University Hospital of Dijon — Dijon, France (Not_yet_recruiting)
- Hopital Claude Huriez CHRU Lille — Lille, France (Not_yet_recruiting)
- CHU Montpellier — Montpellier, France (Not_yet_recruiting)
- CHU De Nice Hopital Pasteur 2 — Nice, France (Not_yet_recruiting)
- Hopital Saint-Louis AP-HP Pitor — Paris, France (Not_yet_recruiting)
- APHP, Sorbonne University, Pitie Salpetriere Hospital — Paris, France (Not_yet_recruiting)
- Necker-Enfants Malades Hospital — Paris, France (Not_yet_recruiting)
- Hopitaux Universitaires de Strasbourg — Strasbourg, France (Not_yet_recruiting)
- Toulouse University Hospital - Hopital de Rangueil — Toulouse, France (Not_yet_recruiting)
- Uniklinik RWTH Aachen — Aachen, Germany (Not_yet_recruiting)
- Charite, Dept of Nephrology — Berlin, Germany (Not_yet_recruiting)
- Clinic for Infectiology - Essen — Essen, Germany (Not_yet_recruiting)
- University Hospital Greifswald — Greifswald, Germany (Not_yet_recruiting)
- Clinic for stem cell transplantation - Hamburg (UKE) — Hamburg, Germany (Not_yet_recruiting)
- Hannover Medical School - Resp Medicine — Hannover, Germany (Not_yet_recruiting)
- Uniklinik Leipzig — Leipzig, Germany (Not_yet_recruiting)
- Medicine Clinic of Johannes Gutenberg - Mainz university — Mainz, Germany (Not_yet_recruiting)
- Ludwig-Maximilians University (LMU) Hospital — Munich, Germany (Not_yet_recruiting)
- University of Ulm — Ulm, Germany (Not_yet_recruiting)
- Universitaetsklinikum Wuerzburg — Wurzburg, Germany (Not_yet_recruiting)
- Policlinico Gemelli - Roma — Roma, Italy (Not_yet_recruiting)
- Erasmus MC Cancer Institute — Rotterdam, Netherlands (Not_yet_recruiting)
- UMC Utrecht (Hematology) — Utrecht, Netherlands (Not_yet_recruiting)
- University of Belgrade — Belgrade, Serbia (Not_yet_recruiting)
- Clinical Center of Vojvodina — Novi Sad, Serbia (Not_yet_recruiting)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (Not_yet_recruiting)
- Hospital de Cruces — Bilbao, Spain (Not_yet_recruiting)
- Hospital Virgen de las Nieves — Granada, Spain (Not_yet_recruiting)
- Hospital Dr. Negrin — Las Palmas, Spain (Not_yet_recruiting)
- Hospital 12 de Octubre — Madrid, Spain (Not_yet_recruiting)
- Hospital Puerta del Hierro — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario Marques de Valdecilla — Santander, Spain (Not_yet_recruiting)
- University Hospital of Geneva — Geneva, Switzerland (Not_yet_recruiting)
- University Hospitals Birmingham — Birmingham, United Kingdom (Not_yet_recruiting)
- Royal Papworth Hospital (Cambridge) — Cambridge, United Kingdom (Not_yet_recruiting)
- University College Hospital London — London, United Kingdom (Not_yet_recruiting)
- Kings College Hospital (London) — London, United Kingdom (Not_yet_recruiting)
- Royal Marsden Hospital (London) — London, United Kingdom (Not_yet_recruiting)
- Manchester Royal Infirmary — Manchester, United Kingdom (Not_yet_recruiting)
- Freeman Hospital Newcastle upon Tyne — Newcastle, United Kingdom (Not_yet_recruiting)
- Nottingham University Hospital NHS trust (Queens Medical Centre) — Nottingham, United Kingdom (Not_yet_recruiting)
- University Hospital Southampton NHS FT — Southampton, United Kingdom (Not_yet_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.