{"id":"prolastin-c","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion-related reactions (fever, chills, malaise)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Injection site reactions"}]},"_chembl":{"chemblId":"CHEMBL3350556","moleculeType":"Small molecule","molecularWeight":"1112.80"},"_dailymed":{"setId":"2b620e6b-6a24-0957-1288-ae529c4cc3a2","title":"PROLASTIN-C LIQUID (ALPHA1-PROTEINASE INHIBITOR (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Alpha-1 antitrypsin (AAT) is a serine protease inhibitor that protects lung tissue from neutrophil elastase and other proteases released during inflammation. In alpha-1 antitrypsin deficiency, insufficient AAT levels allow unopposed protease activity, leading to progressive lung destruction. Prolastin-C is an intravenous augmentation therapy derived from human plasma that restores AAT levels to therapeutic thresholds, thereby slowing the decline in lung function and reducing emphysema progression.","oneSentence":"Prolastin-C is a purified human alpha-1 protease inhibitor (AAT) that replaces deficient or dysfunctional alpha-1 antitrypsin to protect lung tissue from enzymatic degradation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T02:06:18.632Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Alpha-1 antitrypsin deficiency with emphysema or chronic obstructive pulmonary disease (COPD)"}]},"trialDetails":[{"nctId":"NCT01983241","phase":"PHASE3","title":"Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Grifols Therapeutics LLC","startDate":"2013-11","conditions":"Pulmonary Emphysema in Alpha-1 PI Deficiency","enrollment":345},{"nctId":"NCT02796937","phase":"PHASE3","title":"Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency","status":"ENROLLING_BY_INVITATION","sponsor":"Grifols Therapeutics LLC","startDate":"2016-07","conditions":"Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency","enrollment":290},{"nctId":"NCT04722887","phase":"PHASE1, PHASE2","title":"A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin Deficiency","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2021-08-13","conditions":"Alpha1-Antitrypsin Deficiency","enrollment":17},{"nctId":"NCT05671887","phase":"","title":"DREAM: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies","status":"RECRUITING","sponsor":"Northwestern University","startDate":"2022-11-16","conditions":"Lung Cancer, Bilateral Cancer, Lung Transplant","enrollment":125},{"nctId":"NCT06602986","phase":"NA","title":"Measuring the Density of Iodine in Lipiodol Depositions: Detecting an Invisible Residual Tumor After Conventional Transarterial Chemoembolization for Hepatocellular Carcinoma","status":"NOT_YET_RECRUITING","sponsor":"Pak Emirates Military Hospital","startDate":"2024-10-12","conditions":"HCC - Hepatocellular Carcinoma","enrollment":96},{"nctId":"NCT05582798","phase":"PHASE4","title":"Bronchiectasis Alpha-1 Augmentation Trial- Modulating Airway Neutrophil Function","status":"COMPLETED","sponsor":"University of Dundee","startDate":"2022-11-01","conditions":"Bronchiectasis Adult","enrollment":20},{"nctId":"NCT02947087","phase":"PHASE1, PHASE2","title":"Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis","status":"COMPLETED","sponsor":"Medical University of South Carolina","startDate":"2017-01-11","conditions":"Chronic Pancreatitis","enrollment":48},{"nctId":"NCT02870348","phase":"PHASE1, PHASE2","title":"Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE)","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2016-07-29","conditions":"Alpha1-Antitrypsin Deficiency","enrollment":4},{"nctId":"NCT02870309","phase":"PHASE1, PHASE2","title":"Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin Deficiency","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2016-07-29","conditions":"Alpha1-Antitrypsin Deficiency","enrollment":4},{"nctId":"NCT01731691","phase":"PHASE2, PHASE3","title":"Safety and Efficacy of (α1Proteinase Inhibitor, α1PI) in HIV Disease","status":"TERMINATED","sponsor":"Institute for Human Genetics and Biochemistry","startDate":"2012-04","conditions":"HIV Disease","enrollment":12},{"nctId":"NCT03632538","phase":"","title":"AKI Cardiosurgery Diagnostic Study (AKI-CDS)","status":"UNKNOWN","sponsor":"University of Rostock","startDate":"2018-07-27","conditions":"Acute Kidney Injury, Renal Replacement Therapy","enrollment":40},{"nctId":"NCT02093221","phase":"PHASE2","title":"Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus","status":"TERMINATED","sponsor":"Grifols Therapeutics LLC","startDate":"2014-03","conditions":"Type 1 Diabetes Mellitus","enrollment":76},{"nctId":"NCT01319331","phase":"PHASE1","title":"The Effects of Alpha-1 Antitrypsin (AAT) on the Progression of Type 1 Diabetes","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2010-10","conditions":"Diabetes, Type 1 Diabetes","enrollment":12},{"nctId":"NCT02282527","phase":"PHASE2, PHASE3","title":"A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2014-10","conditions":"Alpha₁-Antitrypsin Deficiency","enrollment":32},{"nctId":"NCT01661192","phase":"PHASE2","title":"Long Term Treatment Effect of the Safety, Tolerability and Efficacy of AAT in Type 1 Diabetes","status":"COMPLETED","sponsor":"Rabin Medical Center","startDate":"2013-01","conditions":"Type 1 Diabetes, Beta Cell Preservation","enrollment":12},{"nctId":"NCT01936896","phase":"PHASE1, PHASE2","title":"Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction","status":"COMPLETED","sponsor":"Virginia Commonwealth University","startDate":"2013-12","conditions":"Acute Myocardial Infarction","enrollment":10},{"nctId":"NCT01213043","phase":"PHASE2","title":"Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency","status":"COMPLETED","sponsor":"Grifols Therapeutics LLC","startDate":"2010-11","conditions":"Emphysema, Alpha 1-antitrypsin Deficiency (AATD)","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":15,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["AAT"],"phase":"marketed","status":"active","brandName":"Prolastin-C","genericName":"Prolastin-C","companyName":"Grifols Therapeutics LLC","companyId":"grifols-therapeutics-llc","modality":"Biologic","firstApprovalDate":"","aiSummary":"Prolastin-C is a purified human alpha-1 protease inhibitor (AAT) that replaces deficient or dysfunctional alpha-1 antitrypsin to protect lung tissue from enzymatic degradation. Used for Alpha-1 antitrypsin deficiency with emphysema or chronic obstructive pulmonary disease (COPD).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}