Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT00730769
Status:
COMPLETED
Last Update Posted:
2011-09-21
First Post:
2008-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-19', 'studyFirstSubmitDate': '2008-08-05', 'studyFirstSubmitQcDate': '2008-08-07', 'lastUpdatePostDateStruct': {'date': '2011-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dissapeareance of CMV (pp65) antigenemia, determined in peripheral blood mononuclear cells (PBMC).', 'timeFrame': 'Baseline, day 5, 10, 15, 21 of treatment and day 30, 60 and 90 of follow-up.'}], 'secondaryOutcomes': [{'measure': 'Dissapareance of Cytomegalovirus viremia measured by PCR, determined in plasma samples.', 'timeFrame': 'Basal, day 5, 10, 15 and 21 of treatment and 30, 60 and 90 of treatment.'}, {'measure': 'Area under the curve (AUC) of Ganciclovir after ganciclovir i.v. and valganciclovir oral in steady state.', 'timeFrame': 'Day 5 (ganciclovir i.v) and day 15 (valganciclovir oral)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Valganciclovir', 'Ganciclovir', 'Pharmacokinetics', 'Solid organ transplantation', 'Transplant'], 'conditions': ['Cytomegalovirus Infection']}, 'referencesModule': {'references': [{'pmid': '19738014', 'type': 'DERIVED', 'citation': 'Caldes A, Colom H, Armendariz Y, Garrido MJ, Troconiz IF, Gil-Vernet S, Lloberas N, Pou L, Peraire C, Grinyo JM. Population pharmacokinetics of ganciclovir after intravenous ganciclovir and oral valganciclovir administration in solid organ transplant patients infected with cytomegalovirus. Antimicrob Agents Chemother. 2009 Nov;53(11):4816-24. doi: 10.1128/AAC.00085-09. Epub 2009 Sep 8.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study were:\n\n1. To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV infection/disease in SOT patients (kidney, liver and heart recipients) based on 21 days of treatment.\n2. To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with respect to ganciclovir given intravenously (i.v.).\n3. Evaluate the security of this treatment with valganciclovir.', 'detailedDescription': 'SOT recipients (kidney, liver and heart transplant) presenting CMV infection or disease were eligible for inclusion if they were ≥18 years of age and presented a positive CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC). Patients excluded were those with severe CMV tissue invasive disease, unable to receive oral medication, absolute neutrophil counts less than 500/ mm3, platelets \\<25000 platelets/mm3, Hemoglobin\\< 80g/l or estimated glomerular filtration rate\\< 10 mL/min (according to the Cockcroft-Gault formula).\n\nPatients received a short induction treatment with ganciclovir i.v (Cymevene®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at the dose of 5 mg/kg/12h, by a peripherical vein infusion of one hour, during 5 days followed by treatment with oral valganciclovir (Valcyte®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 900 mg/12h during 16 days, after meals, until complete a total of 21 days of treatment. In patients with impaired renal function ganciclovir i.v. and oral valganciclovir doses were adjusted at each visit according to estimated Glomerular Filtration Rate (GFR) by Cockcroft-Gault equation, as recommended by the manufacturer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age, solid organ transplant recipients.\n* presented a CMV infection demonstrated by CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC).\n* gave written informed consent.\n\nExclusion Criteria:\n\n* HIV patients.\n* Multiorganic transplant.\n* Severe CMV tissue invasive disease.\n* Unable to receive oral medication.\n* absolute neutrophil counts less than 500/ mm3.\n* Platelets \\<25000 platelets/mm3.\n* Hemoglobin\\< 80g/l.\n* Estimated glomerular filtration rate\\< 10 mL/min (according to the Cockcroft-Gault formula)'}, 'identificationModule': {'nctId': 'NCT00730769', 'briefTitle': 'Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'Phase IV.II Pilot Study of Treatment of Cytomegalovirus Infection With a Brief Induction With Ganciclovir i.v. Followed by Valganciclovir Oral in Solid Organ Transplant Patients.', 'orgStudyIdInfo': {'id': 'VALGAN-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'Patients received a short induction of IV ganciclovir (Cymevene®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 5 mg/kg bid for 5 days (1 hour infusion) , followed by treatment with oral valganciclovir (Valcyte®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 900 mg bid (after meals) for 16 days up to complete 21 days of treatment. In patients with impaired renal function, IV ganciclovir and oral valganciclovir doses were adjusted at each visit according to estimated GFR (Cockcroft-Gault equation)', 'interventionNames': ['Drug: Single arm (ganciclovir and valganciclovir)']}], 'interventions': [{'name': 'Single arm (ganciclovir and valganciclovir)', 'type': 'DRUG', 'otherNames': ['Ganciclovir (Cymevene®)', 'Valganciclovir (Valcyte®)'], 'description': 'Patients received a short induction of IV ganciclovir at 5 mg/kg bid for 5 days (1 hour infusion) , followed by treatment with oral valganciclovir at 900 mg bid (after meals) for 16 days up to complet 21 days of treatment. In patients with impaired renal function, IV ganciclovir and oral valganciclovir doses were adjusted at each visit according to estimated GFR (Cockroft-Gault equation)', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelone', 'country': 'Spain', 'facility': 'Hospital Universitari Bellvitge- Transplant Departments (Liver, Heart and Kidney)', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'overallOfficials': [{'name': 'Salvador - Gil-Vernet, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Nephrology Department. Hospital Universitari of Bellvitge'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salvador Gil-Vernet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Nephrologist', 'investigatorFullName': 'Salvador Gil-Vernet', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}