[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02796937":3,"trial-entities:NCT02796937":288,"trial-summary:NCT02796937":291},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":41,"secondary_outcomes":52,"sex":74,"minimum_age":75,"maximum_age":76,"healthy_volunteers":15,"eligibility_criteria":77,"std_ages":95,"locations":98,"central_contacts":284,"overall_officials":285,"references":286,"see_also_links":287},"NCT02796937","GTi1201-OLE","Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency","An Open-Label, Multicenter Study to Evaluate the Long-term Safety of Weekly Intravenous Alpha1-Proteinase Inhibitor (Human), Modified Process 60 mg\u002Fkg in Subjects With Pulmonary Emphysema Due to Alpha1-Antitrypsin Deficiency","ENROLLING_BY_INVITATION","2029-02","2026-06","2026-06-23","2016-07","Grifols Therapeutics LLC","INDUSTRY",false,"This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60 mg\u002Fkg\u002Fweek in subjects with alpha1-antitrypsin deficiency (AATD).","This is a 2-year open-label extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha-1 MP 60 mg\u002Fkg\u002Fweek in subjects with AATD.\n\nThe study consists of a Screening Visit (the same visit as the End-of-Study Visit in the GTi1201 study for subjects who complete the GTi1201 study or is the same visit as the Early Discontinuation Visit for subjects meeting the early withdrawal criterion for forced expiratory volume in 1 second \\[FEV1\\] decline), a treatment period of 104 weeks (beginning immediately after screening \\[on the same day as the Screening Visit\\] but no sooner than 1 week after the last infusion of investigational product in the GTi1201 study), and an End-of-Study Visit.\n\nSubjects meeting the entrance criteria of the extension study will begin receiving weekly intravenous (IV) infusions of Alpha-1 MP 60 mg\u002Fkg on the day of screening and will continue to receive weekly infusions for a total of 104 infusions.\n\nSafety assessments will include adverse events, concomitant medications, complete physical examination (excluding breast and genitourinary examination), hematology, chemistry, urine cotinine, and pregnancy test. Efficacy assessments will include whole lung computed tomography density, quality-of-life assessment, carbon monoxide diffusing capacity, and pulmonary function tests. The occurrence of chronic obstructive pulmonary exacerbations, will also be evaluated as a safety and as an efficacy measurement.",[19],"Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency",[21,22,23,24,25],"Pulmonary Emphysema","Alpha-1 Antitrypsin Deficiency","AATD","Alpha-1 PI Deficiency","Alpha-1 Proteinase Inhibitor","INTERVENTIONAL","TREATMENT",[29],"PHASE3",{"count":31,"type":32},290,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"BIOLOGICAL","Alpha-1 MP","Alpha-1 MP 60 mg\u002Fkg\u002Fweek for up to 104 weeks",[36],[40],"Prolastin-C",[42,46,49],{"measure":43,"description":44,"timeFrame":45},"Adverse events (AEs)","Monitoring of AEs","Week 1 through Week 108",{"measure":47,"description":48,"timeFrame":45},"Serious AEs (SAEs)","Monitoring of SAEs",{"measure":50,"description":51,"timeFrame":45},"Discontinuations from the study due to AEs","Monitoring of discontinuations due to AEs",[53,57,61,64,67,71],{"measure":54,"description":55,"timeFrame":56},"Change from baseline in whole lung PD15 (15th percentile point)","Whole lung PD15 measured by computed tomography scans","Week 1 through Week 104",{"measure":58,"description":59,"timeFrame":60},"Change from baseline in carbon monoxide diffusing capacity (DLco)","DLco performed according to American Thoracic Society\u002FEuropean Respiratory Society (ATS\u002FERS) guidelines","Week 52 and Week 104",{"measure":62,"description":63,"timeFrame":60},"Changes from baseline in forced expiratory volume in 1 second (FEV1)","FEV1 performed according to ATS\u002FERS guidelines",{"measure":65,"description":66,"timeFrame":60},"Change from baseline in Saint George's Respiratory Questionnaire","Health-related quality of life assessment tool",{"measure":68,"description":69,"timeFrame":70},"Incidence and severity of Chronic Obstructive Pulmonary Disease (COPD)exacerbations","Severe COPD exacerbations as defined by ATS\u002FERS guidelines","Week 2 through Week 108",{"measure":72,"description":73,"timeFrame":60},"Change from baseline in the EQ-5D-5L Questionnaire","Heath-related quality of life assessment tool","ALL","20 Years","72 Years",{"inclusion":78,"exclusion":81,"raw_text":94},[79,80],"Has completed participation in Study GTi1201 (ie, completed Week 156 and Week 160\u002FEnd-of-Study Visit) OR has experienced a decline in FEV1 at the annualized rate of ≥134.4 mL\u002Fyear at or after the Week 104 Visit in GTi1201.","Is willing and able to provide informed consent",[82,83,84,85,86,87,88,89,90,91,92,93],"Is unable to physically or mentally undergo a CT scan (eg, unable to fit inside the CT scanner, claustrophobic).","Has severe concomitant disease including, but not limited to, congestive heart failure and liver cirrhosis.","Has primary and\u002For secondary (metastatic disease) pulmonary malignancy or other current malignancy with \\\u003C1 year predicted overall survival.","Has a metal object (newly received since starting GTi1201) that might interfere with chest CT quality and quantification. Metal objects include, but are not limited to, cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile, metal weapon fragments, or metal shoulder prosthesis.","Is a female who is pregnant, breastfeeding or, if of child-bearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; condom or occlusive cap with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository; male sterilization; or abstinence) throughout the study.","Has clinical signs and symptoms of viral infection requiring virus safety testing at the Week 160\u002FEnd-of-Study Visit or Early Discontinuation Visit in Study GTi1201, and the virus safety test results are indicative of acute or chronic infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or parvovirus B19 (B19V). Note: If the virus safety test results are indicative of acute or chronic infection with HAV, HBV, HCV, HIV, or B19V, the subject will be considered a screen failure and must be withdrawn from the study.","Has current evidence of smoking, which includes electronic\u002Fvapor cigarettes, or has a positive urine cotinine test at the Week 160\u002FEnd-of- Study Visit in Study GTi1201 that is due to smoking.","Has current evidence of chronic alcoholism or illicit drug abuse (addiction).","Is currently participating in another investigational product (IP) study.","Has a history of anaphylaxis or severe systemic response to any plasma- derived alpha1-PI preparation or other blood product(s).","In the opinion of the investigator, is likely to have compliance problems with the protocol and the procedures of the protocol.","Has any medical condition that the investigator feels might confound the results of the study or pose an additional risk to the subject during study participation.","Inclusion Criteria:\n\n* Has completed participation in Study GTi1201 (ie, completed Week 156 and Week 160\u002FEnd-of-Study Visit) OR has experienced a decline in FEV1 at the annualized rate of ≥134.4 mL\u002Fyear at or after the Week 104 Visit in GTi1201.\n* Is willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Is unable to physically or mentally undergo a CT scan (eg, unable to fit inside the CT scanner, claustrophobic).\n* Has severe concomitant disease including, but not limited to, congestive heart failure and liver cirrhosis.\n* Has primary and\u002For secondary (metastatic disease) pulmonary malignancy or other current malignancy with \\\u003C1 year predicted overall survival.\n* Has a metal object (newly received since starting GTi1201) that might interfere with chest CT quality and quantification. Metal objects include, but are not limited to, cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile, metal weapon fragments, or metal shoulder prosthesis.\n* Is a female who is pregnant, breastfeeding or, if of child-bearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; condom or occlusive cap with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository; male sterilization; or abstinence) throughout the study.\n* Has clinical signs and symptoms of viral infection requiring virus safety testing at the Week 160\u002FEnd-of-Study Visit or Early Discontinuation Visit in Study GTi1201, and the virus safety test results are indicative of acute or chronic infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or parvovirus B19 (B19V). Note: If the virus safety test results are indicative of acute or chronic infection with HAV, HBV, HCV, HIV, or B19V, the subject will be considered a screen failure and must be withdrawn from the study.\n* Has current evidence of smoking, which includes electronic\u002Fvapor cigarettes, or has a positive urine cotinine test at the Week 160\u002FEnd-of- Study Visit in Study GTi1201 that is due to smoking.\n* Has current evidence of chronic alcoholism or illicit drug abuse (addiction).\n* Is currently participating in another investigational product (IP) study.\n* Has a history of anaphylaxis or severe systemic response to any plasma- derived alpha1-PI preparation or other blood product(s).\n* In the opinion of the investigator, is likely to have compliance problems with the protocol and the procedures of the protocol.\n* Has any medical condition that the investigator feels might confound the results of the study or pose an additional risk to the subject during study participation.",[96,97],"ADULT","OLDER_ADULT",[99,108,115,122,129,136,143,151,157,163,169,175,182,188,192,198,205,212,220,227,233,239,245,252,258,265,272,278],{"facility":100,"city":101,"state":102,"zip":103,"country":104,"geoPoint":105},"Grifols Investigative Site","Phoenix","Arizona","85013","United States",{"lat":106,"lon":107},33.44838,-112.07404,{"facility":100,"city":109,"state":110,"zip":111,"country":104,"geoPoint":112},"Miami","Florida","33136",{"lat":113,"lon":114},25.77427,-80.19366,{"facility":100,"city":116,"state":117,"zip":118,"country":104,"geoPoint":119},"Wilmington","North Carolina","28401",{"lat":120,"lon":121},34.23556,-77.94604,{"facility":100,"city":123,"state":124,"zip":125,"country":104,"geoPoint":126},"Portland","Oregon","97239",{"lat":127,"lon":128},45.52345,-122.67621,{"facility":100,"city":130,"state":131,"zip":132,"country":104,"geoPoint":133},"Charleston","South Carolina","29425",{"lat":134,"lon":135},32.77632,-79.93275,{"facility":100,"city":137,"state":138,"zip":139,"country":104,"geoPoint":140},"Tyler","Texas","75708",{"lat":141,"lon":142},32.35126,-95.30106,{"facility":100,"city":144,"state":145,"zip":146,"country":147,"geoPoint":148},"Darlinghurst","New South Wales","2010","Australia",{"lat":149,"lon":150},-33.87939,151.21925,{"facility":100,"city":152,"zip":153,"country":147,"geoPoint":154},"Adelaide","5000",{"lat":155,"lon":156},-34.92866,138.59863,{"facility":100,"city":158,"zip":159,"country":147,"geoPoint":160},"Chermside","4032",{"lat":161,"lon":162},-27.38472,153.03062,{"facility":100,"city":164,"zip":165,"country":147,"geoPoint":166},"Fitzroy","3065",{"lat":167,"lon":168},-37.79839,144.97833,{"facility":100,"city":170,"zip":171,"country":147,"geoPoint":172},"Nedlands","6009",{"lat":173,"lon":174},-31.98184,115.8073,{"facility":100,"city":176,"zip":177,"country":178,"geoPoint":179},"Halifax","B3H 3A7","Canada",{"lat":180,"lon":181},44.64269,-63.57688,{"facility":100,"city":183,"zip":184,"country":178,"geoPoint":185},"Toronto","M5T 3A9",{"lat":186,"lon":187},43.70643,-79.39864,{"facility":100,"city":189,"zip":190,"country":191},"Arhus C","8000","Denmark",{"facility":100,"city":193,"zip":194,"country":191,"geoPoint":195},"Hellerup","2900",{"lat":196,"lon":197},55.73204,12.57093,{"facility":100,"city":199,"zip":200,"country":201,"geoPoint":202},"Tallinn","13419","Estonia",{"lat":203,"lon":204},59.43696,24.75353,{"facility":100,"city":206,"zip":207,"country":208,"geoPoint":209},"Turku","20520","Finland",{"lat":210,"lon":211},60.45148,22.26869,{"facility":100,"city":213,"state":214,"zip":215,"country":216,"geoPoint":217},"Bron","Rhone","69677","France",{"lat":218,"lon":219},45.73865,4.91303,{"facility":100,"city":221,"zip":222,"country":223,"geoPoint":224},"Chisinau","2025","Moldova",{"lat":225,"lon":226},47.00902,28.85938,{"facility":100,"city":228,"zip":222,"country":229,"geoPoint":230},"Auckland","New Zealand",{"lat":231,"lon":232},-36.84853,174.76349,{"facility":100,"city":234,"zip":235,"country":229,"geoPoint":236},"Christchurch","8011",{"lat":237,"lon":238},-43.53333,172.63333,{"facility":100,"city":240,"zip":241,"country":229,"geoPoint":242},"Hamilton","3200",{"lat":243,"lon":244},-37.78333,175.28333,{"facility":100,"city":246,"zip":247,"country":248,"geoPoint":249},"Krakow","31-066","Poland",{"lat":250,"lon":251},50.06143,19.93658,{"facility":100,"city":253,"zip":254,"country":248,"geoPoint":255},"Warsaw","01-138",{"lat":256,"lon":257},52.22977,21.01178,{"facility":100,"city":259,"zip":260,"country":261,"geoPoint":262},"Barnaul","656038","Russia",{"lat":263,"lon":264},53.36199,83.72786,{"facility":100,"city":266,"zip":267,"country":268,"geoPoint":269},"Gothenburg","413 45","Sweden",{"lat":270,"lon":271},57.70716,11.96679,{"facility":100,"city":273,"zip":274,"country":268,"geoPoint":275},"Malmö","20502",{"lat":276,"lon":277},55.60587,13.00073,{"facility":100,"city":279,"zip":280,"country":268,"geoPoint":281},"Stockholm","11361",{"lat":282,"lon":283},59.32938,18.06871,[],[],[],[],{"nct_id":4,"conditions":289,"biomarkers":290},[22,21],[],{"nct_id":4,"found":15,"summary":292,"prompt_version":292},null]