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The high concentration (20%) allows for smaller injection volumes compared to lower-concentration formulations.","oneSentence":"IgPro20 is a subcutaneous immunoglobulin replacement therapy that provides passive immunity by delivering polyclonal human immunoglobulins to patients with primary immunodeficiency.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:48:08.735Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunodeficiency disorders requiring immunoglobulin replacement therapy"},{"name":"Secondary immunodeficiency in patients with recurrent infections"}]},"trialDetails":[{"nctId":"NCT06976476","phase":"PHASE2","title":"Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2025-05-08","conditions":"Multiple Myeloma, Hypogammaglobulinemia, Hypogammaglobulinemia, Acquired","enrollment":100},{"nctId":"NCT07076446","phase":"PHASE4","title":"An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID)","status":"RECRUITING","sponsor":"CSL Behring","startDate":"2025-07-15","conditions":"Primary Immunodeficiency","enrollment":8},{"nctId":"NCT04044690","phase":"PHASE3","title":"A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)","status":"TERMINATED","sponsor":"CSL Behring","startDate":"2019-10-21","conditions":"Dermatomyositis","enrollment":134},{"nctId":"NCT06524739","phase":"PHASE3","title":"Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS","status":"TERMINATED","sponsor":"CSL Behring","startDate":"2024-08-28","conditions":"Post-COVID Postural Orthostatic Tachycardia 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Requiring IgG Replacement Therapy (EU Extension Study)","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2008-08","conditions":"Primary Immunodeficiency (PID)","enrollment":40},{"nctId":"NCT01458171","phase":"PHASE3","title":"Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2011-04","conditions":"Primary Immune Deficiency Disorder","enrollment":23},{"nctId":"NCT00419341","phase":"PHASE3","title":"Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2006-11","conditions":"Primary Immune Deficiency","enrollment":49},{"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":[{"count":2,"reaction":"MENINGITIS ASEPTIC"},{"count":1,"reaction":"ABDOMINAL PAIN"},{"count":1,"reaction":"ASTHMA"},{"count":1,"reaction":"CYST"},{"count":1,"reaction":"DIARRHOEA"},{"count":1,"reaction":"DRUG ERUPTION"},{"count":1,"reaction":"DYSTONIA"},{"count":1,"reaction":"ENCEPHALITIS"},{"count":1,"reaction":"FLUID INTAKE REDUCED"},{"count":1,"reaction":"HERPES ZOSTER OTICUS"}],"_approvalHistory":[],"publicationCount":31,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["IgG with Proline","IgG with Proline (IgPro)","Hizentra","HIZENTRA®","HIZENTRA"],"phase":"marketed","status":"active","brandName":"IgPro20","genericName":"IgPro20","companyName":"CSL Behring","companyId":"csl-behring","modality":"Biologic","firstApprovalDate":"","aiSummary":"IgPro20 is a subcutaneous immunoglobulin replacement therapy that provides passive immunity by delivering polyclonal human immunoglobulins to patients with primary immunodeficiency. Used for Primary immunodeficiency disorders requiring immunoglobulin replacement therapy, Secondary immunodeficiency in patients with recurrent infections.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":3},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}