Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT06057194
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588473', 'term': 'letermovir'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Clinical trial of a prospective cohort compared to a retrospective (historical control) cohort.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2023-09-15', 'studyFirstSubmitQcDate': '2023-09-25', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of CMV disease/replication', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'CMV replication: The term \'replication\' can be used to indicate evidence of multiplication and is sometimes used interchangeably with CMV infection\n\nCMV disease: It is defined as symptomatic replication or invasive disease of organs or tissues that requires treatment at the investigator\'s discretion."'}], 'secondaryOutcomes': [{'measure': 'Antiviral prophylaxis received:', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Doses administered of Letermovir or Valganciclovir'}, {'measure': 'Dose of non anti-viral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Drug Dose (mg/hour)'}, {'measure': 'Administration route of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Drug Administration Route'}, {'measure': 'Duration of treatment of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Drug treatment duration (days)'}, {'measure': 'Discontinuation of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Drug Reason for Discontinuation'}, {'measure': 'Reduction of the antiviral dose related to CMV antiviral toxicity', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Number of events of reduction'}, {'measure': 'Substitution of letermovir by intravenous ganciclovir or foscarnet IV, related to CMV antiviral toxicity', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Number of substitutions'}, {'measure': 'Dose changes of immunosuppressive therapy related to CMV antiviral toxicity', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Number of changes'}, {'measure': 'Changes of immunosuppressive therapy related to CMV antiviral toxicity', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Number of changes'}, {'measure': 'Use of granulocyte colony-stimulating factors (G-CSF).', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Number of events (use)'}, {'measure': 'Incidence of leucopenia', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Incidence of leucopenia. (leucopenia will be considered if the total leukocyte count is less than 3,000/mL)'}, {'measure': 'Incidence of neutropenia', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Incidence of leucopenia. (neutropenia will be considered if the total neutrophil count is less than 1,000/mL)'}, {'measure': 'Hospital readmission associated with CMV complication', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Number of events'}, {'measure': 'Incidence of viral, bacterial, or opportunistic fungal infections during the study follow-up period.', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Number of events'}, {'measure': 'Incidence of renal toxicity directly related to CMV antivirals.', 'timeFrame': 'During 12 months after initiation of prophylaxis', 'description': 'Number of events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung transplant', 'CMV prophylaxis', 'Cytomegalovirus'], 'conditions': ['Infections, Cytomegalovirus']}, 'descriptionModule': {'briefSummary': 'The goal of this quasi-experimental multicenter before-after cohort study, phase II study is to evaluate the efficacy of 12-month letermovir prophylaxis in lung transplant recipients (D+/R-) compared to a historical cohort of lung transplant recipients (D+/R-) who received 12 months of valganciclovir prophylaxis to prevent CMV disease."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria (prospective cohort):\n\n* Adults over 18 years old\n* Lung transplant recipients (D+/R-) pre-transplant.\n* Having an undetectable CMV polymerase chain reaction assay (PCR) within the 96 hours prior to the start of letermovir prophylaxis.\n* Patients who have provided written informed consent.\n\nExclusion Criteria (prospective cohort):\n\n* HIV-infected patients.\n* Patients with multivisceral transplant.\n* Patients unable to comply with the follow-up protocol.\n* Receiving a different antiviral prophylaxis other than ganciclovir prior to letermovir prophylaxis.\n* Patients with concurrent renal and hepatic insufficiency.\n\nInclusion Criteria (retrospective cohort):\n\n* Adults over 18 years old. Lung transplant recipients (D+/R-) pre-transplant.\n* Patients treated with Valganciclovir prophylaxis for 12 months.\n* Patients transplanted within 2 years prior to the start of the study.\n* Patients with a complete 13-month follow-up and comparable data to the prospective cohort to evaluate the study's primary variables.\n\nExclusion Criteria (retrospective cohort):\n\n* HIV-infected patients.\n* Patients with multivisceral transplant."}, 'identificationModule': {'nctId': 'NCT06057194', 'acronym': 'LETERCOR', 'briefTitle': 'Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.', 'organization': {'class': 'OTHER', 'fullName': 'Maimónides Biomedical Research Institute of Córdoba'}, 'officialTitle': 'Prospective Study to Assess the Efficacy of Letermovir Prophylaxis in Preventing CMV Infection in Lung Transplant Recipients Compared to a Retrospective Cohort Treated With Standard Valganciclovir Prophylaxis for 12 Months (LETERCOR Study)', 'orgStudyIdInfo': {'id': 'FCO-LET-2022-01'}, 'secondaryIdInfos': [{'id': '2023-504384-16-00', 'type': 'OTHER', 'domain': 'EMA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Letermovir (prospective cohort)', 'description': '2 tablets of 240 milligrams (mg) Letermovir orally once daily. during 12 months', 'interventionNames': ['Drug: Letermovir 240 mg Oral Tablet']}, {'type': 'NO_INTERVENTION', 'label': 'Valganciclovir (retrospective cohort)', 'description': 'Retrospective cohort, of patients treated with Valganciclovir during 12 months'}], 'interventions': [{'name': 'Letermovir 240 mg Oral Tablet', 'type': 'DRUG', 'description': 'Treatment will commence as soon as subjects can receive oral medication, with a maximum timeframe of 28 days after transplantation. If patients cannot receive oral medication after transplantation, initial prophylaxis with ganciclovir per clinical practice will be allowed. Medication will be discontinued 12 months after treatment initiation.', 'armGroupLabels': ['Letermovir (prospective cohort)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14004', 'city': 'Córdoba', 'state': 'Córdoba', 'country': 'Spain', 'contacts': [{'name': 'Aurora Paez Vega, Ph.D', 'role': 'CONTACT', 'email': 'aumapave@hotmail.com'}, {'name': 'Julián C De la Torre Cisneros, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Reina Sofia', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}], 'centralContacts': [{'name': 'Jose C Garrido Gracia, Ph.D', 'role': 'CONTACT', 'email': 'josecarlos.garrido@imibic.org', 'phone': '+34677906567'}], 'overallOfficials': [{'name': 'Julián C De la Torre Cisneros, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Reina Sofia de Cordoba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maimónides Biomedical Research Institute of Córdoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'MERCK SHARP & DOHME DE ESPAÑA S.A.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}