{"id":"cmv-hyperimmune-globulin","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Thrombosis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This is a polyclonal immunoglobulin preparation enriched with antibodies specific to CMV antigens. It works by providing immediate humoral immunity through passive transfer of pre-formed antibodies, which bind to CMV virions and infected cells, facilitating viral neutralization and clearance. This approach is particularly useful in immunocompromised patients who cannot mount an adequate endogenous immune response.","oneSentence":"CMV hyperimmune globulin provides passive immunization by supplying high-titer antibodies against cytomegalovirus (CMV) to prevent or reduce severity of CMV infection.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:29:20.938Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of CMV disease in immunocompromised patients (e.g., transplant recipients, HIV-positive individuals)"},{"name":"Treatment of CMV infection in immunocompromised hosts"}]},"trialDetails":[{"nctId":"NCT07096453","phase":"PHASE1, PHASE2","title":"CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients","status":"RECRUITING","sponsor":"University of Minnesota","startDate":"2025-10-02","conditions":"Kidney Transplant; Complications, CMV","enrollment":30},{"nctId":"NCT07009548","phase":"PHASE4","title":"CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients","status":"ENROLLING_BY_INVITATION","sponsor":"Fernanda P Silveira, MD, MS","startDate":"2025-06-26","conditions":"Cytomegalovirus (CMV) Infection","enrollment":45},{"nctId":"NCT04934527","phase":"PHASE2","title":"Association of T Gamma Delta-CD16+ Cells and Anti-CMV Immunoglobulins in the Prevention of CMV Infection","status":"COMPLETED","sponsor":"University Hospital, Bordeaux","startDate":"2021-11-17","conditions":"Kidney Transplantation, CMV Infection","enrollment":42},{"nctId":"NCT01376778","phase":"PHASE3","title":"A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)","status":"COMPLETED","sponsor":"The George Washington University Biostatistics Center","startDate":"2012-04","conditions":"Congenital Cytomegalovirus Infection, Maternal Cytomegalovirus Infection","enrollment":399},{"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":"NCT00214240","phase":"NA","title":"The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease","status":"COMPLETED","sponsor":"University of Wisconsin, Madison","startDate":"2000-01","conditions":"Cytomegalovirus","enrollment":28},{"nctId":"NCT00881517","phase":"PHASE2, PHASE3","title":"Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection","status":"COMPLETED","sponsor":"Fondazione IRCCS Policlinico San Matteo di Pavia","startDate":"2009-06","conditions":"Cytomegalovirus Infection","enrollment":124},{"nctId":"NCT00137748","phase":"PHASE2, PHASE3","title":"Cytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients","status":"COMPLETED","sponsor":"The Cleveland Clinic","startDate":"2001-01","conditions":"Hypogammaglobulinemia","enrollment":50}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":107,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["CMV-IGIV","Cytogam"],"phase":"marketed","status":"active","brandName":"CMV hyperimmune globulin","genericName":"CMV hyperimmune globulin","companyName":"The George Washington University Biostatistics Center","companyId":"the-george-washington-university-biostatistics-center","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CMV hyperimmune globulin provides passive immunization by supplying high-titer antibodies against cytomegalovirus (CMV) to prevent or reduce severity of CMV infection. Used for Prevention of CMV disease in immunocompromised patients (e.g., transplant recipients, HIV-positive individuals), Treatment of CMV infection in immunocompromised hosts.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}