{"id":"plasbumin-20","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypervolemia"},{"rate":null,"effect":"Pulmonary edema"},{"rate":null,"effect":"Allergic reactions"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"}]},"_chembl":{"chemblId":"CHEMBL3646171","moleculeType":"Small molecule","molecularWeight":"408.51"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Human serum albumin (HSA) is a naturally occurring protein that maintains plasma oncotic pressure and serves as a carrier for various endogenous and exogenous substances. Plasbumin-20 is a 20% concentration albumin solution administered intravenously to restore blood volume and improve hemodynamic stability in hypovolemic states. It helps maintain adequate tissue perfusion and oxygen delivery by expanding the intravascular compartment.","oneSentence":"Plasbumin-20 is a human serum albumin solution that acts as a plasma volume expander and colloid to restore intravascular oncotic pressure and improve tissue perfusion.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:29:05.210Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypovolemia and shock management"},{"name":"Plasma volume restoration in critical care settings"},{"name":"Albumin replacement in hypoalbuminemia"}]},"trialDetails":[{"nctId":"NCT04869397","phase":"PHASE2","title":"Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal Stromal Cells","status":"TERMINATED","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","startDate":"2021-06-14","conditions":"Covid19","enrollment":19},{"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 Syndrome","enrollment":16},{"nctId":"NCT06911554","phase":"PHASE3","title":"A Study of Recombinant Human Albumin Injection to Treat Hypoalbuminemia in Cirrhotic Patients With Ascites","status":"COMPLETED","sponsor":"Tonghua Anrate Biopharmaceutical Co., Ltd.","startDate":"2023-06-16","conditions":"Hepatic Ascites","enrollment":416},{"nctId":"NCT06681415","phase":"PHASE4","title":"Efficacy of 20% Human Albumin in Reducing Pleural Effusion After Cardiopulmonary Bypass","status":"COMPLETED","sponsor":"Pauls Stradins Clinical University Hospital","startDate":"2022-09-01","conditions":"Pleural Effusions Post Coronary Artery Bypass Graft, Hypoxia, Hypoalbuminemia","enrollment":70},{"nctId":"NCT03869385","phase":"PHASE3","title":"Albumin Replacement Therapy in Septic Shock","status":"TERMINATED","sponsor":"Jena University Hospital","startDate":"2019-10-21","conditions":"Septic Shock","enrollment":440},{"nctId":"NCT06411743","phase":"PHASE2","title":"Phase II/III of Recombinant Human Albumin Injection","status":"COMPLETED","sponsor":"The First Hospital of Jilin University","startDate":"2021-09-07","conditions":"Hepatic Ascites","enrollment":90},{"nctId":"NCT06355479","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia","status":"COMPLETED","sponsor":"Healthgen Biotechnology Corp.","startDate":"2023-04-10","conditions":"Hypoalbuminemia, Hepatic Cirrhosis","enrollment":328},{"nctId":"NCT04839991","phase":"PHASE1","title":"Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours.","status":"UNKNOWN","sponsor":"Crescendo Biologics Ltd.","startDate":"2021-06-08","conditions":"Advanced and/or Metastatic Solid Tumours","enrollment":70},{"nctId":"NCT03818737","phase":"PHASE3","title":"Multicenter Trial of Stem Cell Therapy for Osteoarthritis (MILES)","status":"COMPLETED","sponsor":"Emory University","startDate":"2019-03-28","conditions":"Osteoarthritis","enrollment":475},{"nctId":"NCT02097121","phase":"PHASE3","title":"OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)","status":"TERMINATED","sponsor":"Allergan","startDate":"2014-05-23","conditions":"Urinary Incontinence, Urinary Bladder, Overactive","enrollment":56},{"nctId":"NCT04835480","phase":"PHASE2","title":"A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites","status":"RECRUITING","sponsor":"Healthgen Biotechnology Corp.","startDate":"2021-03-22","conditions":"Cirrhotic Ascites","enrollment":220},{"nctId":"NCT02560519","phase":"PHASE4","title":"Albumin in Cardiac Surgery","status":"COMPLETED","sponsor":"Helsinki University Central Hospital","startDate":"2017-03-21","conditions":"C.Surgical Procedure; Cardiac","enrollment":1386},{"nctId":"NCT01822600","phase":"PHASE4","title":"The Therapeutic Role of Intravenous Albumin Administration for Peptic Ulcer Bleeding Patients With Hypoalbuminemia","status":"COMPLETED","sponsor":"National Cheng-Kung University Hospital","startDate":"2010-01","conditions":"Peptic Ulcer Bleeding, Hypoalbuminemia","enrollment":91},{"nctId":"NCT01561053","phase":"PHASE2, PHASE3","title":"A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease","status":"COMPLETED","sponsor":"Instituto Grifols, S.A.","startDate":"2012-04-19","conditions":"Alzheimer's Disease","enrollment":347},{"nctId":"NCT01545076","phase":"PHASE3","title":"Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)","status":"COMPLETED","sponsor":"CSL Behring","startDate":"2012-03","conditions":"Chronic Inflammatory Demyelinating Polyneuropathy, Polyradiculoneuropathy","enrollment":208},{"nctId":"NCT02479581","phase":"PHASE2","title":"The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass","status":"COMPLETED","sponsor":"Xiangya Hospital of Central South University","startDate":"2015-07","conditions":"Valvular Heart Disease","enrollment":226},{"nctId":"NCT00220779","phase":"PHASE2","title":"Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2002-12","conditions":"Multiple Sclerosis, Relapsing-Remitting","enrollment":128},{"nctId":"NCT00220740","phase":"PHASE3","title":"Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2004-04","conditions":"Polyradiculoneuropathy, Chronic Inflammatory Demyelinating","enrollment":117},{"nctId":"NCT00220805","phase":"PHASE2","title":"Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2004-01","conditions":"Macular Degeneration","enrollment":96},{"nctId":"NCT00263887","phase":"PHASE2","title":"Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2003-12","conditions":"Alpha 1-Antitrypsin Deficiency","enrollment":77},{"nctId":"NCT01418521","phase":"PHASE4","title":"Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) After Cardiac Surgery","status":"UNKNOWN","sponsor":"Rambam Health Care Campus","startDate":"2011-08","conditions":"Elective Cardiac Surgery","enrollment":300},{"nctId":"NCT00068055","phase":"PHASE1, PHASE2","title":"IVIG - West Nile Encephalitis: Safety and Efficacy","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2003-09","conditions":"West Nile Virus","enrollment":62}],"_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":[],"phase":"phase_3","status":"active","brandName":"Plasbumin®-20","genericName":"Plasbumin®-20","companyName":"Healthgen Biotechnology Corp.","companyId":"healthgen-biotechnology-corp","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Plasbumin-20 is a human serum albumin solution that acts as a plasma volume expander and colloid to restore intravascular oncotic pressure and improve tissue perfusion. Used for Hypovolemia and shock management, Plasma volume restoration in critical care settings, Albumin replacement in hypoalbuminemia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}