{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T23:53:56Z","timestamp":1773100436672,"version":"3.50.1"},"reference-count":22,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2022,11,30]],"date-time":"2022-11-30T00:00:00Z","timestamp":1669766400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion Medicine"],"published-print":{"date-parts":[[2023,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>This trial investigated the efficacy and safety of the new 10% human intravenous immunoglobulin (IVIg) BT595 (Yimmugo\u00ae).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Adult patients with chronic immune thrombocytopenia (ITP) received a total dose of 2\u00a0g\/kg body weight (bw) IVIg either over 2 or 5\u2009days.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Response as defined by the European Medicines Agency (EMA) was achieved in 18 of 34 patients (52.9%) in the full analysis set (FAS), with a complete response in 11 patients (32.4%). The median time to response was 1.0\u2009days (range 1\u20134); the median duration was 28.0\u2009days. In a subgroup with a baseline platelet count &lt;20*10<jats:sup>9<\/jats:sup>\/L evaluated according to FDA criteria, a platelet response \u226550*10<jats:sup>9<\/jats:sup>\/L was achieved in 18 of 19 patients at day 8. No fatal case occured. One serious treatment\u2010emergent adverse event (TEAE) (anaemia, not related) was reported (2.9%). The most frequent infusional adverse drug reaction (ADR) was headache, which was reported for 14.7% of all patients. All other infusional ADRs (pyrexia, [intravascular] haemolysis, skin reaction, tinnitus, and Coombs test positive) occurred in only one patient (2.9%). Premedication was administered only once. The 5\u2010day schedule showed less side effects with similar efficacy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The benefit\u2010risk profile of BT595 is favourable.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration Number<\/jats:title><jats:p>Eudra CT Number 2015\u2010003653\u201017, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link> NCT02859909.<\/jats:p><\/jats:sec>","DOI":"10.1111\/tme.12943","type":"journal-article","created":{"date-parts":[[2022,11,30]],"date-time":"2022-11-30T08:09:44Z","timestamp":1669795784000},"page":"165-173","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Efficacy and safety of <scp>BT595<\/scp> (10% human intravenous immunoglobulin) in adult patients with chronic immune thrombocytopenia"],"prefix":"10.1111","volume":"33","author":[{"given":"Judit","family":"Demeter","sequence":"first","affiliation":[{"name":"Department of Hematology Semmelweis University Medical School  Budapest Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aryan","family":"Hamed","sequence":"additional","affiliation":[{"name":"II. Belgy\u00f3gy\u00e1szat\u2010Hematol\u00f3giai oszt\u00e1ly Petz Alad\u00e1r Megyei Oktat\u00f3 K\u00f3rh\u00e1z  Gy\u0151r Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Szerafin","family":"L\u00e1szl\u00f3","sequence":"additional","affiliation":[{"name":"J\u00f3sa Andr\u00e1s Oktat\u00f3k\u00f3rh\u00e1z, Haematol\u00f3giai Oszt\u00e1ly Szabolcs\u2010Szatm\u00e1r\u2010Bereg Megyei K\u00f3rh\u00e1zak \u00e9s Egyetemi Oktat\u00f3k\u00f3rh\u00e1z  Ny\u00edregyh\u00e1za Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nada","family":"Suvajdzic","sequence":"additional","affiliation":[{"name":"Clinic of Haematology Clinical Center of Serbia  Belgrade Serbia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silke","family":"Aigner","sequence":"additional","affiliation":[{"name":"Biotest AG  Dreieich Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Birgit","family":"B\u00f6rner","sequence":"additional","affiliation":[{"name":"Biotest AG  Dreieich Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8687-7687","authenticated-orcid":false,"given":"Christiane","family":"Staiger","sequence":"additional","affiliation":[{"name":"Biotest AG  Dreieich Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,11,30]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra010501"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood\u20102008\u201007\u2010162503"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(81)92400-4"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1080\/14728214.2017.1294158"},{"issue":"1","key":"e_1_2_8_6_1","first-page":"36","article-title":"Management of chronic immune thrombocytopenic purpura in children and adults","volume":"35","author":"Blanchette V","year":"1998","journal-title":"Semin Hematol"},{"issue":"3","key":"e_1_2_8_7_1","first-page":"72","article-title":"Role of intravenous immunoglobulin G in autoimmune hematologic disorders","volume":"29","author":"Blanchette VS","year":"1992","journal-title":"Semin Hematol"},{"key":"e_1_2_8_8_1","unstructured":"European Medicines Agency(2021)Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg). 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