Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-11 @ 7:42 PM
Study NCT ID:
NCT02784756
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2016-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-29', 'studyFirstSubmitDate': '2016-02-10', 'studyFirstSubmitQcDate': '2016-05-24', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomatic CMV disease', 'timeFrame': '1 year', 'description': 'Number of participants with symptomatic CMV disease (including viral syndrome and tissue invasive disease) at 1 year post-transplant.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of CMV viremia', 'timeFrame': '1 year', 'description': 'Occurrence of CMV viremia as measured by QuantiFERON-CMV assay (\\> 1000 IU/mL)'}, {'measure': 'positive vs. negative cell-mediated immunity assays', 'timeFrame': '1 year', 'description': 'Incidence of positive vs. negative cell-mediated immunity assays post-transplant'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quantiferon-CMV', 'solid organ transplant', 'CMV Disease'], 'conditions': ['Cytomegalovirus Viraemia']}, 'referencesModule': {'references': [{'pmid': '32504089', 'type': 'DERIVED', 'citation': 'Gibson L. An Interferon-gamma Release Assay for Evaluation of Cell-mediated Immunity in Infants With Congenital Cytomegalovirus Infection. Clin Infect Dis. 2021 Aug 2;73(3):374-375. doi: 10.1093/cid/ciaa700. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The study will prospectively determine the clinical utility of CMV cell-mediated immunity using the Quantiferon test. The investigators will use the assay results to tailor the duration of CMV prophylaxis in solid organ transplant patients.', 'detailedDescription': 'Cytomegalovirus (CMV) disease is an important cause of morbidity in solid organ transplantation recipients and remains the most common opportunistic viral infection in these patients. Standard CMV prevention strategies include universal prophylaxis and pre-emptive therapy with viral load monitoring. However, neither of these strategies has been successful in eliminating CMV disease as seen by high rates of viremia, incidence, and CMV recurrence despite treatment. Recently, the Quantiferon-CMV assay has been shown to predict late CMV reactivation after prophylaxis and to be predictive of viral progression and the need for antiviral therapy in organ transplant recipients who develop low level CMV viremia. The purpose of the current study is to test the clinical strategy of using the Quantiferon-CMV assay in guiding the duration of primary CMV prophylaxis in solid organ transplant patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult kidney, kidney-pancreas, liver transplant recipient, or heart transplant recipient\n* CMV D+/R- patient or any R+ patient who received antithymocyte globulin induction therapy\n\nExclusion Criteria:\n\n* Unable to comply with protocol\n* Campath (Alemtuzumab) induction\n* Receiving another investigational compound for CMV treatment or prophylaxis.\n* Allergy to valganciclovir or ganciclovir\n* Receiving an investigational compound for prevention or treatment of rejection, or participating in another interventional study'}, 'identificationModule': {'nctId': 'NCT02784756', 'acronym': 'QFT-CMV', 'briefTitle': 'Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients: A Multi-Center Study', 'orgStudyIdInfo': {'id': '15-9877'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Quantiferon-CMV assay', 'description': 'All patients will receive a CMV-immunity test at specific time points during the study. This is a single arm design', 'interventionNames': ['Device: Quantiferon-CMV assay']}], 'interventions': [{'name': 'Quantiferon-CMV assay', 'type': 'DEVICE', 'armGroupLabels': ['Quantiferon-CMV assay']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2G3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital - Providence Health", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5C 2T2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network, Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Atul Humar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}, {'name': 'Deepali Kumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian National Transplant Research Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}