{"id":"kedrion-ivig-10","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Infusion reactions"},{"rate":null,"effect":"Thrombosis"},{"rate":null,"effect":"Aseptic meningitis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"IVIG contains polyvalent immunoglobulins (primarily IgG) derived from pooled human plasma that can bind to pathogens, opsonize antigens, and activate complement. It also modulates autoimmune and inflammatory responses through Fc receptor engagement, anti-idiotypic antibody interactions, and immune tolerance mechanisms. The 10% concentration indicates a higher protein concentration suitable for intravenous administration.","oneSentence":"Kedrion IVIG 10% is an intravenous immunoglobulin preparation that provides passive immunity by supplying pooled human antibodies to modulate immune responses and neutralize pathogens.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:49:06.145Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunodeficiency disorders"},{"name":"Secondary immunodeficiency (e.g., in hematologic malignancies)"},{"name":"Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy)"}]},"trialDetails":[{"nctId":"NCT07059000","phase":"PHASE3","title":"A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)","status":"RECRUITING","sponsor":"Kedrion S.p.A.","startDate":"2025-08-13","conditions":"Chronic Primary Immune Thrombocytopenia (ITP)","enrollment":40},{"nctId":"NCT06752356","phase":"PHASE3","title":"A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","status":"RECRUITING","sponsor":"Kedrion S.p.A.","startDate":"2026-04","conditions":"Chronic Inflammatory Demyelinating Polyneuropathy","enrollment":161},{"nctId":"NCT04944979","phase":"PHASE3","title":"Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Kedrion S.p.A.","startDate":"2021-03-31","conditions":"Primary Immunodeficiency Disease","enrollment":30},{"nctId":"NCT03961009","phase":"PHASE3","title":"Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients","status":"COMPLETED","sponsor":"Kedrion S.p.A.","startDate":"2019-04-30","conditions":"Primary Immunodeficiency Disease","enrollment":47},{"nctId":"NCT01581593","phase":"PHASE3","title":"Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)","status":"COMPLETED","sponsor":"Kedrion S.p.A.","startDate":"2012-11-12","conditions":"Primary Immunodeficiency, Agammaglobulinemia, Hypogammaglobulinemia","enrollment":45}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["KIg 10"],"phase":"phase_3","status":"active","brandName":"Kedrion IVIG 10%","genericName":"Kedrion IVIG 10%","companyName":"Kedrion S.p.A.","companyId":"kedrion-s-p-a","modality":"Biologic","firstApprovalDate":"","aiSummary":"Kedrion IVIG 10% is an intravenous immunoglobulin preparation that provides passive immunity by supplying pooled human antibodies to modulate immune responses and neutralize pathogens. Used for Primary immunodeficiency disorders, Secondary immunodeficiency (e.g., in hematologic malignancies), Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}