Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-13 @ 11:15 PM
Study NCT ID:
NCT03698435
Status:
UNKNOWN
Last Update Posted:
2019-10-10
First Post:
2018-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
(Val)Ganciclovir TDM in Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}, {'id': 'D054069', 'term': 'Multiple Acyl Coenzyme A Dehydrogenase Deficiency'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D028361', 'term': 'Mitochondrial Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015774', 'term': 'Ganciclovir'}, {'id': 'D000077562', 'term': 'Valganciclovir'}], 'ancestors': [{'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2018-10-03', 'lastUpdatePostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure of CMV treatment (with valganciclovir and ganciclovir) using viral load measurements and determining mutations in CMV kinase gene UL97 and DNA polymerase gene UL54', 'timeFrame': '12 months after transplantation', 'description': 'How many days to the development of failure of treatment? Failure of treatment is defined by increased viral load (measured in serum, whole blood, plasma in copies per mL and/or viral resistance (change of ganciclovir treatment to foscarnet treatment as a consequence, resistance is determined by resistance testing determining CMV kinase gene UL97 and DNA polymerase gene UL54 for mutations) or death due to CMV.'}], 'secondaryOutcomes': [{'measure': 'Breakthrough CMV infection during CMV prophylaxis with valganciclovir', 'timeFrame': '12 months after transplantation', 'description': 'Breakthrough CMV infection during prophylaxis with valganciclovir, time (days) to development of breakthrough CMV infection during prophylaxis'}, {'measure': 'Therapeutic window', 'timeFrame': '12 months after transplantation', 'description': 'How many levels are in and out of the therapeutic window (how many low and high levels)?'}, {'measure': 'Successful treatment while receiving (val)ganciclovir determined by two consequtive negative viral loads', 'timeFrame': '12 months after transplantation', 'description': 'The proportion of patients from CMV treatment group who have a successful CMV treatment, successful CMV treatment is defined by viral load \\<100 copies/mL (measured twice in a row).'}, {'measure': '(Val)ganciclovir for treatment outcomes (1)', 'timeFrame': '12 months after transplantation', 'description': 'The proportion of patients from CMV treatment group who are under-dosed'}, {'measure': '(Val)ganciclovir for treatment outcomes (2)', 'timeFrame': '12 months after transplantation', 'description': 'The proportion of patients from CMV treatment group who develop resistance to ganciclovir'}, {'measure': 'Factors that can influence trough concentrations of (val)ganciclovir (1)', 'timeFrame': '12 months after transplantation', 'description': 'Does the type of transplanted organ (liver, lungs, kidney, heart, stem cell transplant) cause high or low (val)ganciclovir trough concentrations (mg/L)? Defined therapeutic window for prophylaxis is 1-2 mg/L and for therapy is 2-4 mg/L. Number of levels which are out of the therapeutic window for different transplants.'}, {'measure': 'Factors that can influence trough concentrations of (val)ganciclovir (2)', 'timeFrame': '12 months after transplantation', 'description': 'Does the underlying disease for transplantation cause high or low (val)ganciclovir trough concentrations (mg/L)? Defined therapeutic window for prophylaxis is 1-2 mg/L and for therapy is 2-4 mg/L. Number of levels which are out of the therapeutic window for different underlying diseases.'}, {'measure': 'Factors that can influence trough concentrations of (val)ganciclovir (3)', 'timeFrame': '12 months after transplantation', 'description': 'Does dose reduction for renal failure cause increase or decrease in (val)ganciclovir trough concentrations (mg/L)? Number of levels which are out of the therapeutic window after dose reduction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ganciclovir', 'valganciclovir', 'therapeutic drug monitoring', 'pharmacokinetics'], 'conditions': ['Cytomegalovirus Infections']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to gain more insight into therapeutic drug monitoring and thus the pharmacodynamics and pharmacokinetics of ganciclovir, in the context of prophylaxis and treatment of CMV infections, in order to provide the patient with an adequate dose.', 'detailedDescription': 'Patients undergoing solid organ or stem cell transplantation are at risk of developing cytomegalovirus (CMV) infection or reactivation. The risk of CMV infection / reactivation and its severity depends on the CMV serostatus of donor and recipient. Valganciclovir (oral pro-drug of ganciclovir) prophylaxis is used to postpone CMV infection or reactivation to a later point in the post-transplantation.\n\nCMV infection/reactivation does not always lead to clinical disease. Valganciclovir (oral) can be used when CMV DNA is detected in the blood, but patient has no or few complaints. However, in case of severe symptoms such as colitis, nephritis, hepatitis, pneumonitis, uveitis or encephalitis (active CMV disease) then ganciclovir is indicated intravenously. In clinical recovery treatment is often completed with valganciclovir.\n\nIt is important that the ganciclovir level is adequate, because too high level can lead to side effects such as cytopenia and a too low level can lead to treatment failure and resistance development. There are different dosing schedules mentioned in different sources. These schemes are based on dated literature.\n\nThe aim of (val)ganciclovir therapeutic drug monitoring (TDM) is to gain more insight into the pharmacodynamics and pharmacokinetics of ganciclovir, in the context of prophylaxis and treatment of CMV infections, in order to provide the patient with an adequate dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing solid organ or stem cell transplantation are at risk of developing cytomegalovirus (CMV) infection or reactivation. Valganciclovir (oral pro-drug of ganciclovir) prophylaxis is used to postpone CMV infection or reactivation to a later point in the post-transplantation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must receive ganciclovir intravenously or valganciclovir orally as routine care\n* Must have received a solid organ or stem cell transplant\n* Must be be 18 years or older\n\nExclusion Criteria:\n\nThere are no exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT03698435', 'briefTitle': '(Val)Ganciclovir TDM in Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': '(Val)Ganciclovir Therapeutic Drug Monitoring in Transplant Recipients', 'orgStudyIdInfo': {'id': '201800021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prophylaxis', 'description': 'Patients who receive (val)ganciclovir for prophylaxis of cytomegalovirus', 'interventionNames': ['Drug: Ganciclovir', 'Drug: Valganciclovir']}, {'label': 'Treatment', 'description': 'Patients who receive (val)ganciclovir for treatment of cytomegalovirus', 'interventionNames': ['Drug: Ganciclovir', 'Drug: Valganciclovir']}], 'interventions': [{'name': 'Ganciclovir', 'type': 'DRUG', 'otherNames': ['Cymevene'], 'description': 'Intravenous ganciclovir + TDM', 'armGroupLabels': ['Prophylaxis', 'Treatment']}, {'name': 'Valganciclovir', 'type': 'DRUG', 'otherNames': ['Valcyte'], 'description': 'Oral valganciclovir + TDM', 'armGroupLabels': ['Prophylaxis', 'Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'JWC Alffenaar, PhD', 'role': 'CONTACT'}], 'facility': 'UMCG', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'centralContacts': [{'name': 'Anne-Grete Märtson, MSc', 'role': 'CONTACT', 'email': 'a.martson@umcg.nl', 'phone': '+37253325121'}, {'name': 'Marjolein Knoester, MD', 'role': 'CONTACT', 'email': 'm.knoester@umcg.nl', 'phone': '+31503613480'}], 'overallOfficials': [{'name': 'Jan-Willem Alffenaar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical pharmacologist', 'investigatorFullName': 'Jan-Willem C Alffenaar', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}