{"id":"igsc-20-infusion","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"},{"rate":null,"effect":"Infusion reactions"},{"rate":null,"effect":"Thrombosis"},{"rate":null,"effect":"Renal dysfunction"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a 20% concentration immunoglobulin solution, it contains polyclonal IgG antibodies derived from pooled human plasma. It works by providing immediate passive immunity, neutralizing pathogens and toxins, blocking pathogenic autoantibodies, and modulating inflammatory immune responses through Fc receptor engagement and complement regulation. This makes it suitable for both immunodeficiency and autoimmune/inflammatory conditions.","oneSentence":"IGSC 20% is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:15:35.124Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunodeficiency disorders"},{"name":"Secondary immunodeficiency"},{"name":"Autoimmune and inflammatory conditions (e.g., ITP, CIDP, myasthenia gravis)"}]},"trialDetails":[{"nctId":"NCT05645107","phase":"PHASE3","title":"A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","status":"RECRUITING","sponsor":"Grifols Therapeutics LLC","startDate":"2022-12-26","conditions":"Hypogammaglobulinemia, Bacterial Infections, B-cell Chronic Lymphocytic Leukemia","enrollment":386},{"nctId":"NCT04842643","phase":"PHASE3","title":"An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease","status":"COMPLETED","sponsor":"Takeda","startDate":"2021-04-27","conditions":"Primary Immunodeficiency Disease","enrollment":12},{"nctId":"NCT04346108","phase":"PHASE3","title":"A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2020-08-11","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":17},{"nctId":"NCT05059977","phase":"PHASE1","title":"A Study of TAK-881 in Healthy Adults","status":"COMPLETED","sponsor":"Takeda","startDate":"2021-10-12","conditions":"Healthy Volunteers","enrollment":24},{"nctId":"NCT04566692","phase":"PHASE4","title":"A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2020-11-24","conditions":"Primary Immunodeficiency","enrollment":33},{"nctId":"NCT03116347","phase":"PHASE4","title":"Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2017-05-30","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":42},{"nctId":"NCT01218438","phase":"PHASE2, PHASE3","title":"Phase 2/3 Study of IGSC, 20% in PIDD","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2013-01-28","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":86},{"nctId":"NCT01412385","phase":"PHASE2, PHASE3","title":"Immune Globulin Subcutaenous (Human), 20%","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2011-06-20","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":55},{"nctId":"NCT02806986","phase":"PHASE3","title":"Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2016-06","conditions":"Primary Immunodeficiency","enrollment":61},{"nctId":"NCT03814798","phase":"PHASE3","title":"Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency","status":"WITHDRAWN","sponsor":"Grifols Therapeutics LLC","startDate":"2019-12","conditions":"Primary Immunodeficiency","enrollment":""},{"nctId":"NCT02604810","phase":"PHASE3","title":"Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2016-01","conditions":"Primary Immunodeficiency","enrollment":53},{"nctId":"NCT00542997","phase":"PHASE3","title":"Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2007-09","conditions":"Common Variable Immunodeficiency, X-linked Agammaglobulinemia, Autosomal Recessive Agammaglobulinemia","enrollment":51}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Immune Globulin Infusion (Human)"],"phase":"phase_3","status":"active","brandName":"IGSC 20% infusion","genericName":"IGSC 20% infusion","companyName":"Takeda","companyId":"takeda","modality":"Biologic","firstApprovalDate":"","aiSummary":"IGSC 20% is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins. Used for Primary immunodeficiency disorders, Secondary immunodeficiency, Autoimmune and inflammatory conditions (e.g., ITP, CIDP, myasthenia gravis).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}