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Kingdom","UK",{"type":45,"coordinates":1265},[1266,1267],-1.89983,52.48142,{"lat":1267,"lon":1266},[1270],{"name":1271,"role":32,"phone":1272,"phoneExt":24,"email":1273},"Charles Percy, MD","44 121 371 4351","hayley.ellis@uhb.nhs.uk",{"facility":1275,"status":38,"city":1276,"state":24,"zip":1277,"country":1262,"countryCode":1263,"cosmosGeoPoint":1278,"geoPoint":1282,"contacts":1283},"Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation","Bradford","BD9 6RJ",{"type":45,"coordinates":1279},[1280,1281],-1.75206,53.79391,{"lat":1281,"lon":1280},[1284,1288],{"name":1285,"role":32,"phone":1286,"phoneExt":24,"email":1287},"Samuel Ackroyd, MD","441274383383","Stephen.Cox@bthft.nhs.uk",{"name":24,"role":32,"phone":24,"phoneExt":24,"email":671},{"facility":1290,"status":38,"city":1291,"state":24,"zip":1292,"country":1262,"countryCode":1263,"cosmosGeoPoint":1293,"geoPoint":1297,"contacts":1298},"University Hospitals Coventry and Warwickshire NHS Trust","Coventry","CV2 2DX",{"type":45,"coordinates":1294},[1295,1296],-1.51217,52.40656,{"lat":1296,"lon":1295},[1299],{"name":1300,"role":32,"phone":1301,"phoneExt":24,"email":1302},"Benjamin Bailiff, MD","+44 2476 967151","benjamin.bailiff@uhcw.nhs.uk",{"facility":1304,"status":38,"city":1305,"state":24,"zip":1306,"country":1262,"countryCode":1263,"cosmosGeoPoint":1307,"geoPoint":1311,"contacts":1312},"Glasgow Royal Infirmary - North Glasgow University Hospital Division","Glasgow","G4 0ET",{"type":45,"coordinates":1308},[1309,1310],-4.25763,55.86515,{"lat":1310,"lon":1309},[1313],{"name":1314,"role":32,"phone":1315,"phoneExt":24,"email":1316},"Catherine Bagot, MD","441412013770","Jane.Ireland@nhs.scot",{"facility":1318,"status":38,"city":1319,"state":24,"zip":1320,"country":1262,"countryCode":1263,"cosmosGeoPoint":1321,"geoPoint":1325,"contacts":1326},"University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary","Leicester","LE1 5WW",{"type":45,"coordinates":1322},[1323,1324],-1.13169,52.6386,{"lat":1324,"lon":1323},[1327],{"name":1328,"role":32,"phone":1329,"phoneExt":24,"email":1330},"Mamta Garg, MD","+44 1162584739","vernadine.roque@mhs.net",{"facility":1332,"status":38,"city":1333,"state":24,"zip":1334,"country":1262,"countryCode":1263,"cosmosGeoPoint":1335,"geoPoint":1339,"contacts":1340},"Barts and the London Pathology & Pharmacy Building - Barts Health NHS Trust","London","E1 2ES",{"type":45,"coordinates":1336},[1337,1338],-0.12574,51.50853,{"lat":1338,"lon":1337},[1341],{"name":1342,"role":32,"phone":1343,"phoneExt":24,"email":1344},"Frederick Chen, MD","+44 2032460261","s.mamsa@nhs.net",{"facility":1346,"status":38,"city":1333,"state":24,"zip":1347,"country":1262,"countryCode":1263,"cosmosGeoPoint":1348,"geoPoint":1350,"contacts":1351},"Hammersmith Hospital, Imperial College School Of Medicine - Imperial College Healthcare NHS Trust","W12 0HS",{"type":45,"coordinates":1349},[1337,1338],{"lat":1338,"lon":1337},[1352],{"name":1353,"role":32,"phone":1354,"phoneExt":24,"email":1355},"Nichola Cooper, MD","+44 20 331 35711","tung.le1@nhs.net",{"facility":1357,"status":38,"city":1358,"state":24,"zip":1359,"country":1262,"countryCode":1263,"cosmosGeoPoint":1360,"geoPoint":1364,"contacts":1365},"Royal Cornwall Hospital (RCH)","Truro","TR1 3LJ",{"type":45,"coordinates":1361},[1362,1363],-5.05436,50.26526,{"lat":1363,"lon":1362},[1366],{"name":1367,"role":32,"phone":1368,"phoneExt":24,"email":1369},"Adam Forbes, MD","+44 1872 253075","rch-tr.HaematologyTrials@nhs.net",{"type":1371,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100557929","phase-3-a-study-to-assess-the-efficacy-and-safety-of-efgartigimod-iv-in-adult-participants-with-primary-immune-thrombocytopenia-100557929",false,"NCT06544499","A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia","A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia","advance NEXT","Inclusion Criteria:\n\n* Is at least 18 years of age and the local legal age of consent for clinical studies when signing the informed consent form (ICF).\n* Has documented baseline mean platelet count of \\\u003C30 x 10\\^9\u002FL before randomization\n* Has a documented duration of primary immune thrombocytopenia (ITP) of more than 12 months on the date of informed consent form (ICF) signature.\n* Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, intravenous immunoglobulin (IVIg), anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab.\n* Has documented insufficient response to a prior ITP treatment (the specific criteria can be found in the protocol).\n* Has documented prior response defined as 1 platelet count of ≥50 × 109\u002FL to at least 1 of the following ITP treatments in the 3 years before the date of ICF signature: prednisone, dexamethasone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin\n\nExclusion Criteria:\n\n* Other than the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of ITP, confound the results of the study or put the participant at undue risk.\n* Secondary ITP\n* Nonimmune thrombocytopenia\n* Autoimmune hemolytic anemia\n* ITP-associated critical or severe bleeding The complete list of criteria can be found in the protocol.","ALL","18 Years",{"count":1383,"type":1384},69,"ESTIMATED","INTERVENTIONAL",[1387],"PHASE3","The main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod IV in participants with primary immune thrombocytopenia (ITP). After an up to 2 weeks screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV, respectively during the double-blinded treatment period (DBTP). At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first 52-week open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second 52-week OLTP2. After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks.\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Fadvancenext",[1390],"Primary Immune Thrombocytopenia (ITP)","2026-04-29",{"date":1393,"type":1394},"2026-05-01","ACTUAL",{"date":1396,"type":1394},"2024-10-18",{"date":1398,"type":1384},"2028-06",{"name":5,"class":6},94]