Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT06677892
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2024-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection in Belgium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Effectiveness of Maribavir on CMV Viremia Clearance', 'timeFrame': 'Up to 16 weeks', 'description': 'CMV viraemia clearance is defined as last CMV quantitative polymerase chain reaction (PCR) during maribavir treatment. Viral clearance plasma CMV DNA concentration below the lower limit of quantification (\\< LLOQ) less than \\[\\<\\] 137 international units per milliliters (IU/mL).'}, {'measure': 'Duration of Treatment', 'timeFrame': 'From treatment start to discontinuation of maribavir (up to 16 weeks)', 'description': 'Duration of treatment is defined as time from treatment start to discontinuation of maribavir.'}, {'measure': 'Time to Viral Clearance', 'timeFrame': 'From treatment start to achievement of viral clearance (up to 2 years)', 'description': 'Time to viral clearance is defined as time from treatment start to achievement of viral clearance.'}, {'measure': 'Percentage of Participants With Drug Resistance', 'timeFrame': 'Up to 2 years', 'description': 'Percentage of participants with drug resistance (UL97/UL27 genes) testing will be reported.'}, {'measure': 'Number of Participants With Use of Maribavir in Daily Clinical Practice', 'timeFrame': 'Up to 16 weeks'}, {'measure': 'Number of Participants Who Have Refractory CMV Infection With/Without Resistance, or Intolerance to a Previous CMV Treatment', 'timeFrame': 'Up to 16 weeks', 'description': 'Refractory CMV infection with resistance is defined as viral genetic alteration that decreases susceptibility to one or more antiviral drugs.'}, {'measure': 'Percentage of Participants With Recurrence After Maribavir Treatment', 'timeFrame': 'Up to 2 years', 'description': 'Recurrence is defined as plasma CMV DNA concentration greater than or equal to (\\>=) LLOQ in 2 consecutive plasma samples, after achieving confirmed viremia clearance. Viremia clearance will be defined as plasma CMV DNA concentration below the lower limit of quantification (\\< LLOQ) that is \\<137 IU/mL.'}, {'measure': 'Number of Participants With Treatment Related Adverse Events (AEs)', 'timeFrame': 'Up to 2 years', 'description': 'The investigator is required to provide an assessment of the relationship of an AE to the studied drug(s), based on the consideration of all available information about the event, including temporal relationship to drug administration, recognized association with drug product/class, pharmacological plausibility, and alternative etiology (e.g., underlying illness, concurrent conditions, concomitant treatments). An related AE is defined as AE that follows a reasonable temporal sequence from administration of the medication, vaccine, or device (including the course after withdrawal of the medication), and for which a causal relationship is at least a reasonable possibility, i.e., the relationship cannot be ruled out, although factors other than the medication, vaccine, or device, such as underlying diseases, complications, concomitant drugs, and concurrent treatments, may also have contributed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Cytomegalovirus (CMV)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/8db9463ef5b74455??page=1&idFilter=TAK-620-4014', 'label': 'To obtain more information on the study, click here/on this link'}]}, 'descriptionModule': {'briefSummary': "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. Maribavir is a medicine approved for treating CMV infection in adults after transplant.\n\nThe main aim of this study is to check the use of maribavir and learn how safe and effective in treating adults with CMV infection after transplant in Belgium in line with the Belgian reimbursement criteria.\n\nDuring the study, a participant's data will be collected for 2 years. The study does not have fixed visits to the hospital, but it is recommended collect data from routine visits and contacts."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who had a CMV infection/disease after SOT/HSCT and who start maribavir, according to summary of product characteristics (SmPC) and in line with Belgian reimbursement criteria for maribavir will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant signed an informed consent form.\n* Aged greater than or equal to (\\>=) 18 years at the time of consent.\n* Received an HSCT/SOT.\n* Diagnosed with CMV infection/disease any time after the HSCT/SOT date.\n* Starting maribavir for the first time and in line with the Belgian reimbursement criteria.\n\nExclusion Criteria:\n\n• Participant treated with maribavir before the start of the study.'}, 'identificationModule': {'nctId': 'NCT06677892', 'acronym': 'MARIBEL', 'briefTitle': 'A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection in Belgium', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Prospective, Non-interventional Study to Describe The Use of Maribavir and Its Effectiveness in Patients With Post-transplant Cytomegalovirus Infection/Disease in Line With Belgian Reimbursement Conditions (The MARIBEL Study)', 'orgStudyIdInfo': {'id': 'TAK-620-4014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Participants', 'description': 'Participants with post-transplant CMV infection and/or disease that are refractory or intolerant to one or more prior therapies, who have undergone a solid organ transplant/ hematopoietic stem-cell transplantation (SOT/HSCT) and are treated with maribavir for the first time and in line with the Belgian reimbursement criteria, data will be collected and observed prospectively for up to 2 years.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'This is non-interventional study.', 'armGroupLabels': ['All Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Anderlecht', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'phone': '+32 (0) 555 33 34'}, {'name': 'Kemlin, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Erasme', 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}, {'zip': '1070', 'city': 'Anderlecht', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'aspasia.georgala@hubruxelles.be'}, {'name': 'Aspasia Georgala, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}, {'zip': '1200', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'xavier.poire@saintluc.uclouvain.be', 'phone': '02 764 18 55'}, {'name': 'Xavier Poiré, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2640', 'city': 'Edegem', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'anke.verlinden@uza.be'}, {'name': 'Anke Verlinden, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZA', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'steven.vanlaecke@ugent.be; tessa.kerre@uzgent.be', 'phone': '+32 (0)9 332 5861'}, {'name': 'Steven Van Laecke, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tessa Kerre, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZGent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '1090', 'city': 'Jette', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'ann.debecker@uzbrussel.be; karlmartin.wissing@uzbrussel.be', 'phone': '02 477 6055'}, {'name': 'Ann De Becker, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karl Martin Wissing, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZBrussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'johan.maertens@uzleuven.be; robin.vos@uzleuven.be; dirk.kuypers@uzleuven.be', 'phone': '+3216341548; +3216344580'}, {'name': 'Johan Maertens, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Robin Vos, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dirk Kuypers, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZLeuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'antoine.bouquegneau@chuliege.be', 'phone': '04/323.37.92'}, {'name': 'Willems, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Antoine Bouquegneau, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Liège - site Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '5530', 'city': 'Yvoir', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'phone': '+32 81 42 38 74'}, {'name': 'Planté-Bordeneuve, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU UCL Namur - site Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}], 'centralContacts': [{'name': 'Takeda Contact', 'role': 'CONTACT', 'email': 'medinfoUS@takeda.com', 'phone': '+1-877-825-3327'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}