{"id":"valganciclovir-ganciclovir","safety":{"commonSideEffects":[{"rate":"15-30","effect":"Neutropenia"},{"rate":"5-15","effect":"Thrombocytopenia"},{"rate":"5-10","effect":"Anemia"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Diarrhea"},{"rate":"5-10","effect":"Nausea"},{"rate":"5-10","effect":"Renal impairment"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Valganciclovir is rapidly hydrolyzed to ganciclovir in the intestinal wall and liver. Ganciclovir is phosphorylated by viral kinases (particularly CMV UL97 kinase) to form active triphosphate metabolites that inhibit CMV DNA polymerase, preventing viral DNA synthesis and replication. This selective mechanism exploits the presence of viral kinases in infected cells.","oneSentence":"Valganciclovir is a prodrug that is converted to ganciclovir, which inhibits viral DNA polymerase to prevent cytomegalovirus (CMV) replication.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:36:12.673Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"CMV retinitis in immunocompromised patients (HIV/AIDS, transplant recipients)"},{"name":"CMV prophylaxis in high-risk transplant recipients"},{"name":"CMV gastroenteritis and colitis in immunocompromised patients"}]},"trialDetails":[{"nctId":"NCT00092222","phase":"PHASE2","title":"Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2004-10-28","conditions":"Lymphoproliferative Disorder, HHV-8, Malignancy","enrollment":75},{"nctId":"NCT07383649","phase":"PHASE2","title":"Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection","status":"RECRUITING","sponsor":"The Methodist Hospital Research Institute","startDate":"2026-03","conditions":"Brain Cancer Metastatic, CMV Viremia","enrollment":28},{"nctId":"NCT06391918","phase":"PHASE1","title":"Phase 1 Study of GEN2 in Patients With Advanced Solid Tumors","status":"TERMINATED","sponsor":"GenVivo, Inc.","startDate":"2024-03-04","conditions":"Solid Tumor, Adult","enrollment":37},{"nctId":"NCT01419561","phase":"PHASE2","title":"Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2011-09-08","conditions":"KSHV Inflammatory Cytokine Syndrome (KICS), KSHV, HHV-8","enrollment":140},{"nctId":"NCT03586284","phase":"PHASE2, PHASE3","title":"Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes","status":"TERMINATED","sponsor":"University of California, San Francisco","startDate":"2020-03-15","conditions":"Cytomegalovirus Anterior Uveitis","enrollment":51},{"nctId":"NCT07450365","phase":"PHASE4","title":"Evaluation of Long-term Efficacy of 4 to 6-month Course Antiviral Therapy for Neurodevelopmental Impairments Caused by Congenital Cytomegalovirus Infection","status":"NOT_YET_RECRUITING","sponsor":"Hu Bofei","startDate":"2026-02-15","conditions":"Congenital CMV Infection","enrollment":150},{"nctId":"NCT06439342","phase":"PHASE3","title":"A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections","status":"RECRUITING","sponsor":"Takeda","startDate":"2024-12-16","conditions":"Cytomegalovirus (CMV)","enrollment":20},{"nctId":"NCT07235683","phase":"PHASE4","title":"Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients","status":"RECRUITING","sponsor":"University Health Network, Toronto","startDate":"2025-12-24","conditions":"CMV, Lung Transplant Recipient","enrollment":40},{"nctId":"NCT03511118","phase":"","title":"Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants","status":"RECRUITING","sponsor":"Duke University","startDate":"2018-10-04","conditions":"Lactating Women on Select DOI, Breastfed Infants of Mothers on Select DOI","enrollment":1600},{"nctId":"NCT07379203","phase":"PHASE2","title":"ValgaNciclovIR for CMV Viraemia in AdvaNced HIV diseAse","status":"NOT_YET_RECRUITING","sponsor":"Wits Health Consortium (Pty) Ltd","startDate":"2026-02-01","conditions":"Cytomegalovirus (CMV) Infection","enrollment":130},{"nctId":"NCT01199562","phase":"","title":"Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant","status":"ACTIVE_NOT_RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2010-12","conditions":"Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia, Acute Undifferentiated Leukemia","enrollment":153},{"nctId":"NCT06334497","phase":"PHASE3","title":"Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2024-08-14","conditions":"Cytomegalovirus Infection","enrollment":80},{"nctId":"NCT04116411","phase":"PHASE2","title":"A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Cecilia Soderberg-Naucler","startDate":"2019-09-04","conditions":"Glioblastoma Multiforme","enrollment":220},{"nctId":"NCT07294547","phase":"NA","title":"Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study","status":"RECRUITING","sponsor":"National Taiwan University Hospital","startDate":"2025-11-27","conditions":"Kidney Transplantation, Cytomegalovirus Infections, EBV Infection, Antiviral Prophylaxis","enrollment":80},{"nctId":"NCT07266467","phase":"PHASE4","title":"Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Disease in Chinese Kidney Transplant Recipients","status":"RECRUITING","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","startDate":"2025-05-13","conditions":"Kidney Transplant","enrollment":290},{"nctId":"NCT06555432","phase":"","title":"A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea","status":"RECRUITING","sponsor":"Takeda","startDate":"2024-11-14","conditions":"Cytomegalovirus (CMV)","enrollment":168},{"nctId":"NCT06853184","phase":"PHASE2","title":"Study Evaluating the Efficacy and Safety of Artesunate","status":"RECRUITING","sponsor":"Amivas Inc.","startDate":"2025-08-01","conditions":"CMV Infection","enrollment":90},{"nctId":"NCT06034925","phase":"PHASE4","title":"Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients","status":"COMPLETED","sponsor":"Medical University of South Carolina","startDate":"2023-11-06","conditions":"Transplant Complication, CMV","enrollment":70},{"nctId":"NCT06798909","phase":"PHASE3","title":"Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients","status":"RECRUITING","sponsor":"University of California, San Francisco","startDate":"2025-07-22","conditions":"Cytomegalovirus (CMV), Kidney Transplant; Complications, Kidney Diseases","enrollment":360},{"nctId":"NCT07079735","phase":"PHASE2, PHASE3","title":"Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant","status":"RECRUITING","sponsor":"Columbia University","startDate":"2025-09-12","conditions":"CMV Viremia, Heart Transplant Infection, Heart Transplant Failure and Rejection","enrollment":150},{"nctId":"NCT03915366","phase":"PHASE2, PHASE3","title":"Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia","status":"COMPLETED","sponsor":"Hospital Universitario 12 de Octubre","startDate":"2020-03-01","conditions":"Pneumonia, HIV/AIDS, Tuberculosis","enrollment":563},{"nctId":"NCT06102525","phase":"PHASE1, PHASE2","title":"A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Glioblastoma","status":"RECRUITING","sponsor":"Rznomics, Inc.","startDate":"2024-10-08","conditions":"Glioblastoma","enrollment":43},{"nctId":"NCT07138989","phase":"PHASE2","title":"EBV Lytic Reactivation Therapy Combined With PD-1 Antibody in Recurrent/Metastatic Nasopharyngeal Carcinoma","status":"NOT_YET_RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2025-08-19","conditions":"Nasopharyngeal Cancinoma (NPC)","enrollment":10},{"nctId":"NCT05708755","phase":"PHASE2","title":"CMV Immunity Monitoring in Lung Transplant Recipients","status":"RECRUITING","sponsor":"NYU Langone Health","startDate":"2024-09-13","conditions":"Lung Transplant; Complications","enrollment":50},{"nctId":"NCT05011058","phase":"PHASE2","title":"An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas","status":"TERMINATED","sponsor":"Viracta Therapeutics, Inc.","startDate":"2021-05-28","conditions":"Epstein-Barr Virus Associated Lymphoma, EBV-Positive DLBCL, NOS, EBV-Related Non-Hodgkin Lymphoma","enrollment":102},{"nctId":"NCT05041426","phase":"PHASE2","title":"Letermovir for CMV Prevention After Lung Transplantation","status":"COMPLETED","sponsor":"Fernanda P Silveira, MD, MS","startDate":"2021-12-06","conditions":"Lung Transplant, CMV","enrollment":16},{"nctId":"NCT05564598","phase":"PHASE2","title":"CMV CTLs in Neonates With CMV Infection","status":"RECRUITING","sponsor":"New York Medical College","startDate":"2023-07-01","conditions":"Congenital Cytomegaloviral (CMV) Disease","enrollment":23},{"nctId":"NCT03397706","phase":"PHASE1, PHASE2","title":"Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies","status":"COMPLETED","sponsor":"Viracta Therapeutics, Inc.","startDate":"2018-03-29","conditions":"Epstein-Barr Virus-Associated Lymphoma, Lymphoproliferative Disorders","enrollment":64},{"nctId":"NCT05166577","phase":"PHASE1","title":"Nanatinostat Plus Valganciclovir in Advanced EBV+ Solid Tumors and in Combination With Pembrolizumab in EBV+ RM-NPC","status":"TERMINATED","sponsor":"Viracta Therapeutics, Inc.","startDate":"2021-10-08","conditions":"Nasopharyngeal Carcinoma, EBV-Related Gastric Carcinoma, EBV-Related Leiomyosarcoma","enrollment":26},{"nctId":"NCT04724447","phase":"PHASE1, PHASE2","title":"ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION","status":"RECRUITING","sponsor":"Laureate Institute for Brain Research, Inc.","startDate":"2021-11-23","conditions":"Major Depressive Disorder","enrollment":24},{"nctId":"NCT06302140","phase":"PHASE1","title":"A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers","status":"TERMINATED","sponsor":"Viracta Therapeutics, Inc.","startDate":"2024-02-28","conditions":"Advanced Cancer","enrollment":8},{"nctId":"NCT05238220","phase":"","title":"Utilization of the Viracor® Assay for Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients","status":"COMPLETED","sponsor":"Piedmont Healthcare","startDate":"2021-01-04","conditions":"Kidney Transplant; Complications","enrollment":37},{"nctId":"NCT01649869","phase":"PHASE2","title":"Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2015-02-24","conditions":"Cytomegalovirus Infection","enrollment":54},{"nctId":"NCT00227370","phase":"PHASE3","title":"Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation","status":"COMPLETED","sponsor":"Duke University","startDate":"2003-07","conditions":"Cytomegalovirus Infections","enrollment":136},{"nctId":"NCT04064697","phase":"PHASE3","title":"Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy","status":"TERMINATED","sponsor":"Centre Hospitalier Universitaire de Saint Etienne","startDate":"2021-04-22","conditions":"Ulcerative Colitis, Unspecified","enrollment":6},{"nctId":"NCT06057194","phase":"PHASE2","title":"Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.","status":"NOT_YET_RECRUITING","sponsor":"Maimónides Biomedical Research Institute of Córdoba","startDate":"2023-10","conditions":"Infections, Cytomegalovirus","enrollment":90},{"nctId":"NCT03699254","phase":"PHASE3","title":"Clinical Trial of Efficacy and Safety of the Combination of Reduced Duration Prophylaxis Followed by Immuno-guided Prophylaxis in Lung Transplant Recipients.","status":"COMPLETED","sponsor":"Maimónides Biomedical Research Institute of Córdoba","startDate":"2019-04-05","conditions":"Transplantation Infection, Cytomegalovirus Infections","enrollment":150},{"nctId":"NCT02409147","phase":"NA","title":"Initiation of a Deceased Donor Uterine Transplantation Program at the University of Nebraska Medical Center","status":"WITHDRAWN","sponsor":"University of Nebraska","startDate":"2016-01","conditions":"Uterus Transplant","enrollment":""},{"nctId":"NCT03443869","phase":"PHASE3","title":"Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2018-05-03","conditions":"CMV Disease","enrollment":601},{"nctId":"NCT02927067","phase":"PHASE3","title":"A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants","status":"COMPLETED","sponsor":"Shire","startDate":"2017-04-14","conditions":"Cytomegalovirus (CMV)","enrollment":553},{"nctId":"NCT03301415","phase":"PHASE2","title":"Asymptomatic Congenital CMV Treatment","status":"TERMINATED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2019-08-21","conditions":"Congenital Cytomegalovirus Infection","enrollment":7},{"nctId":"NCT00478465","phase":"PHASE1, PHASE2","title":"Valganciclovir (Valcyte) for Chronic Fatigue Syndrome Patients Who Have Elevated Antibody Titers Against Human Herpes Virus 6 (HHV-6)and Epstein-Barr Virus (EBV)","status":"COMPLETED","sponsor":"Stanford University","startDate":"2007-05","conditions":"Chronic Fatigue Syndrome","enrollment":30},{"nctId":"NCT02871401","phase":"PHASE1","title":"A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)","status":"COMPLETED","sponsor":"Vanderbilt University Medical Center","startDate":"2018-01-03","conditions":"Idiopathic Pulmonary Fibrosis","enrollment":31},{"nctId":"NCT01972035","phase":"PHASE2","title":"ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation","status":"COMPLETED","sponsor":"University of Minnesota","startDate":"2014-08-01","conditions":"Transplantation Infection, Epstein-Barr Virus Infections, Cytomegalovirus Infections","enrollment":137},{"nctId":"NCT03107871","phase":"PHASE2","title":"Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants","status":"ACTIVE_NOT_RECRUITING","sponsor":"Albert Park","startDate":"2018-08-31","conditions":"Cmv Congenital, CMV, Congenital Cmv","enrollment":52},{"nctId":"NCT03296553","phase":"PHASE2","title":"Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial.","status":"COMPLETED","sponsor":"National Institute of Cancerología","startDate":"2015-10-01","conditions":"Kaposi Sarcoma, Human Immunodeficiency Virus, Immune Reconstitution Syndrome","enrollment":40},{"nctId":"NCT02931539","phase":"PHASE3","title":"Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir","status":"COMPLETED","sponsor":"Shire","startDate":"2016-12-22","conditions":"Cytomegalovirus (CMV)","enrollment":352},{"nctId":"NCT00006145","phase":"PHASE3","title":"Preventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2000-08","conditions":"Cytomegalovirus Infections, HIV Infections","enrollment":350},{"nctId":"NCT01552369","phase":"PHASE4","title":"CMV Antiviral Prevention Strategies in D+R-Liver Transplants (\"CAPSIL\")","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2012-10-29","conditions":"Cytomegalovirus Infection","enrollment":205},{"nctId":"NCT02439957","phase":"PHASE3","title":"A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus","status":"TERMINATED","sponsor":"Jazz Pharmaceuticals","startDate":"2015-09","conditions":"Cytomegalovirus Disease, Kidney Transplant Infection","enrollment":6},{"nctId":"NCT02439970","phase":"PHASE3","title":"A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease","status":"TERMINATED","sponsor":"Jazz Pharmaceuticals","startDate":"2015-09","conditions":"Cytomegalovirus Disease","enrollment":5},{"nctId":"NCT03339661","phase":"PHASE2","title":"Secondary Prophylaxis After CMV Disease in Kidney Transplant Patients Targeted by γδ T Cells Immunomonitoring.","status":"COMPLETED","sponsor":"University Hospital, Bordeaux","startDate":"2017-11-23","conditions":"Kidney Transplant Infection","enrollment":38},{"nctId":"NCT02005822","phase":"PHASE3","title":"Congenital Cytomegalovirus: Efficacy of Antiviral Treatment","status":"COMPLETED","sponsor":"Dr. Ann C.T.M. Vossen","startDate":"2013-10-22","conditions":"Congenital Cytomegalovirus Infection, Sensorineural Hearing Loss","enrollment":37},{"nctId":"NCT01611974","phase":"PHASE2","title":"Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients","status":"COMPLETED","sponsor":"Shire","startDate":"2012-07-17","conditions":"Cytomegalovirus (CMV)","enrollment":120},{"nctId":"NCT02538172","phase":"NA","title":"Cell-mediated Immunity for Prevention of CMV Disease","status":"COMPLETED","sponsor":"University of Lausanne Hospitals","startDate":"2015-10","conditions":"Cytomegalovirus Infections","enrollment":195},{"nctId":"NCT00400322","phase":"NA","title":"Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection","status":"COMPLETED","sponsor":"Karolinska Institutet","startDate":"2006-08","conditions":"Glioblastoma Multiforme, Cytomegalovirus Infection","enrollment":42},{"nctId":"NCT04278547","phase":"PHASE4","title":"Multicenter Clinical Trial to Evaluate the Efficacy of a Preventive Strategy Against CMV Infection in Heart Transplant Patients, Based on the Specific T Cells Response","status":"UNKNOWN","sponsor":"Hospital Universitari de Bellvitge","startDate":"2020-06-12","conditions":"Heart Transplant Infection, CMV Infection","enrollment":188},{"nctId":"NCT01441063","phase":"PHASE2","title":"Tocilizumab for KSHV-Associated Multicentric Castleman Disease","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2011-09-13","conditions":"Castleman Disease, Multicentric Castleman Disease, Giant Lymph Node Hyperplasia","enrollment":8},{"nctId":"NCT02188719","phase":"PHASE1","title":"Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation","status":"TERMINATED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2014-12-17","conditions":"Liver Transplantation","enrollment":15},{"nctId":"NCT00264290","phase":"PHASE4","title":"Valganciclovir to Reduce T Cell Activation in HIV Infection","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2006-08","conditions":"HIV Infections, Cytomegalovirus Infections","enrollment":30},{"nctId":"NCT00372229","phase":"PHASE3","title":"A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2006-05","conditions":"Cytomegalovirus Infections","enrollment":299},{"nctId":"NCT02606266","phase":"PHASE2, PHASE3","title":"Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance","status":"TERMINATED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2017-07-11","conditions":"Congenital Cytomegalovirus (CMV)","enrollment":1},{"nctId":"NCT01329185","phase":"PHASE2","title":"Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients","status":"COMPLETED","sponsor":"University of Minnesota","startDate":"2011-06","conditions":"EBV Viremia, CMV Viremia","enrollment":17},{"nctId":"NCT03698435","phase":"","title":"(Val)Ganciclovir TDM in Transplant Recipients","status":"UNKNOWN","sponsor":"University Medical Center Groningen","startDate":"2018-05-25","conditions":"Cytomegalovirus Infections","enrollment":100},{"nctId":"NCT00387530","phase":"PHASE2","title":"Phenylbutyrate and Valganciclovir in Treating Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Cancer","status":"WITHDRAWN","sponsor":"University of California, San Diego","startDate":"2006-05","conditions":"Gastric Cancer, Head and Neck Cancer, Lymphoma","enrollment":""},{"nctId":"NCT03631316","phase":"NA","title":"Pharmacokinetic Parameters of Innovative Valganciclovir Versus Generic Valganciclovir","status":"COMPLETED","sponsor":"Luis Eduardo Morales Buenrostro","startDate":"2018-03-01","conditions":"Kidney Transplantation, Cytomegalovirus Infections, Pharmacokinetics","enrollment":8},{"nctId":"NCT01509404","phase":"PHASE4","title":"Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection","status":"COMPLETED","sponsor":"Medical University of South Carolina","startDate":"2011-11","conditions":"Cytomegalovirus Disease","enrollment":40},{"nctId":"NCT01663740","phase":"PHASE4","title":"A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2012-01-30","conditions":"Cytomegalovirus Infections","enrollment":59},{"nctId":"NCT01335932","phase":"PHASE2","title":"Ganciclovir/Valganciclovir for Prevention of CMV Reactivation in Acute Injury of the Lung and Respiratory Failure","status":"COMPLETED","sponsor":"Fred Hutchinson Cancer Center","startDate":"2011-03-10","conditions":"Acute Lung Injury, Acute Respiratory Distress Syndrome, Respiratory Failure","enrollment":160},{"nctId":"NCT00294515","phase":"PHASE3","title":"IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2006-03-31","conditions":"Cytomegalovirus Infections","enrollment":326},{"nctId":"NCT01220895","phase":"PHASE2","title":"Alternate Donor Study of Pre-Emptive Cellular Therapy","status":"COMPLETED","sponsor":"Cell Medica Ltd","startDate":"2010-10","conditions":"Cytomegalovirus Infection","enrollment":52},{"nctId":"NCT01077908","phase":"PHASE3","title":"Cytomegalovirus - Immunoprophylactic Adoptive Cellular Therapy Study","status":"COMPLETED","sponsor":"Cell Medica Ltd","startDate":"2008-07","conditions":"Cytomegalovirus Infection","enrollment":89},{"nctId":"NCT00947141","phase":"PHASE4","title":"Determining a Viral Load Threshold for Treating Cytomegalovirus (CMV)","status":"COMPLETED","sponsor":"University College, London","startDate":"2003-02","conditions":"Viraemia","enrollment":165},{"nctId":"NCT02370758","phase":"NA","title":"Cell Mediated Immunity for Secondary Prophylaxis in CMV SOT Patients","status":"COMPLETED","sponsor":"University Health Network, Toronto","startDate":"2014-11","conditions":"Cytomegalovirus Viraemia","enrollment":32},{"nctId":"NCT01376804","phase":"PHASE4","title":"A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2011-07-31","conditions":"Kidney Transplantation, Cytomegalovirus Infections","enrollment":57},{"nctId":"NCT00034385","phase":"PHASE4","title":"Valganciclovir to Prevent Cytomegalovirus Infection in Kidney and Kidney/Pancreas Transplant Recipients","status":"COMPLETED","sponsor":"National Institutes of Health Clinical Center (CC)","startDate":"2002-04-24","conditions":"Kidney Trasplant","enrollment":12},{"nctId":"NCT00002377","phase":"PHASE3","title":"A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"1997-01","conditions":"Cytomegalovirus Retinitis, HIV Infections","enrollment":""},{"nctId":"NCT00361933","phase":"PHASE4","title":"Valganciclovir to Treat HHV-8 Associated Multicentric Castleman's Disease","status":"WITHDRAWN","sponsor":"University of Washington","startDate":"2008-12","conditions":"Giant Lymph Node Hyperplasia","enrollment":""},{"nctId":"NCT02503982","phase":"PHASE4","title":"Valganciclovir Dosing in Pediatric Solid Organ Transplant Recipients","status":"COMPLETED","sponsor":"Rabin Medical Center","startDate":"2014-12","conditions":"Infection in Solid Organ Transplant Recipients","enrollment":13},{"nctId":"NCT02973464","phase":"","title":"The Strategy in the Prevention of Renal Post-transplant Cytomegalovirus Infection Among Chinese Population","status":"UNKNOWN","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","startDate":"2016-06","conditions":"Renal Transplant Recipients","enrollment":450},{"nctId":"NCT00141037","phase":"PHASE1, PHASE2","title":"Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2004-03","conditions":"Kidney Diseases, Kidney Transplantation, Kidney Transplant","enrollment":130},{"nctId":"NCT00431353","phase":"PHASE4","title":"VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2004-04","conditions":"Cytomegalovirus Infections","enrollment":325},{"nctId":"NCT01165580","phase":"PHASE1","title":"A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2011-05","conditions":"Cytomegalovirus Infections, Heart Transplantation","enrollment":17},{"nctId":"NCT00090766","phase":"PHASE2, PHASE3","title":"A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2004-05","conditions":"Cytomegalovirus Infections","enrollment":63},{"nctId":"NCT00189150","phase":"PHASE4","title":"Pharmacokinetics of Mmf and Valganciclovir","status":"COMPLETED","sponsor":"University of Michigan","startDate":"2005-04","conditions":"Kidney Transplant Recipient, Heart Transplant Recipient","enrollment":16},{"nctId":"NCT02761291","phase":"PHASE1","title":"Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma","status":"UNKNOWN","sponsor":"Chang Gung Memorial Hospital","startDate":"2016-05","conditions":"Nasopharyngeal Carcinoma","enrollment":18},{"nctId":"NCT00377741","phase":"PHASE1","title":"A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2004-12","conditions":"Cytomegalovirus Infections","enrollment":31},{"nctId":"NCT00275314","phase":"PHASE3","title":"WP16302 A Bioequivalence Study Comparing Ganciclovir From the Valganciclovir Syrup Formulation and the Commercial Valganciclovir 450mg Tablet (Valcyte®) at a Dose of 900mg in Kidney Transplant Recipients","status":"TERMINATED","sponsor":"University of Pittsburgh","startDate":"2006-02","conditions":"Kidney Transplant","enrollment":5},{"nctId":"NCT00096538","phase":"NA","title":"Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2004-04","conditions":"Sarcoma","enrollment":6},{"nctId":"NCT00466817","phase":"PHASE3","title":"Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2008-06","conditions":"Cytomegalovirus Infection","enrollment":109},{"nctId":"NCT01255644","phase":"PHASE4","title":"Antiviral Treatment of Chronic Lymphocytic Leukemia","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2010-12","conditions":"Chronic Lymphocytic Leukemia","enrollment":20},{"nctId":"NCT01655212","phase":"PHASE3","title":"Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial","status":"TERMINATED","sponsor":"Dr. Ann C.T.M. Vossen","startDate":"2012-06","conditions":"Congenital Cytomegalovirus Infection, Sensorineural Hearing Loss","enrollment":2},{"nctId":"NCT00330018","phase":"PHASE3","title":"Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)","status":"COMPLETED","sponsor":"Hadassah Medical Organization","startDate":"2006-02","conditions":"Bone Marrow Transplantation, Cytomegalovirus","enrollment":40},{"nctId":"NCT01446445","phase":"PHASE4","title":"Individualization of Ganciclovir and Valganciclovir Doses Using Bayesian Prediction in Renal Transplant Patients.","status":"COMPLETED","sponsor":"Nuria Lloberas","startDate":"2011-12","conditions":"Infection in Solid Organ Transplant Recipients","enrollment":60},{"nctId":"NCT01503918","phase":"PHASE2","title":"Cytomegalovirus Control in Critical Care","status":"COMPLETED","sponsor":"University Hospital Birmingham NHS Foundation Trust","startDate":"2012-01","conditions":"Critical Illness","enrollment":124},{"nctId":"NCT02297854","phase":"PHASE1","title":"Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2011-07","conditions":"Healthy","enrollment":83},{"nctId":"NCT02296723","phase":"PHASE1","title":"Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2011-07","conditions":"Healthy","enrollment":66},{"nctId":"NCT01049633","phase":"","title":"B-Lymphocyte Immunotherapy in Islet Transplantation for Initial Islet Graft Failure","status":"NO_LONGER_AVAILABLE","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"","conditions":"Type 1 Diabetes Mellitus","enrollment":""},{"nctId":"NCT00241345","phase":"PHASE3","title":"Trial of Preemptive Treatment With Oral Valganciclovir Compared With Intravenous (IV) Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant","status":"TERMINATED","sponsor":"Washington University School of Medicine","startDate":"2004-06","conditions":"Cytomegalovirus Infections","enrollment":39},{"nctId":"NCT00217503","phase":"PHASE2","title":"Bortezomib and Antiviral Therapy Followed By Effusion Drainage, Bevacizumab, and Combination Chemotherapy in Treating Patients With Primary Effusion Lymphoma","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2005-07","conditions":"Lymphoma","enrollment":15}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":12,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Valganciclovir/Ganciclovir","genericName":"Valganciclovir/Ganciclovir","companyName":"University Health Network, Toronto","companyId":"university-health-network-toronto","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Valganciclovir is a prodrug that is converted to ganciclovir, which inhibits viral DNA polymerase to prevent cytomegalovirus (CMV) replication. Used for CMV retinitis in immunocompromised patients (HIV/AIDS, transplant recipients), CMV prophylaxis in high-risk transplant recipients, CMV gastroenteritis and colitis in immunocompromised patients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}