{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T04:48:48Z","timestamp":1761540528147,"version":"3.37.3"},"reference-count":0,"publisher":"Georg Thieme Verlag KG","issue":"07","funder":[{"DOI":"10.13039\/100004702","name":"Baxter","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004702","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Thromb Haemost"],"published-print":{"date-parts":[[2004]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Patients with type 2 and 3 von Willebrand disease (VWD) are treated with factor VIII\/VWF concentrate in case of bleeding or surgery. Immunate\u00ae (Baxter, Vienna, Austria) is a double virus inactivated FVIII\/VWF concentrate and is registered in several countries for patients with VWD with reduced FVIII levels.We performed an in vitro, a pharmacokinetic and a clinical study to evaluate Immunate in VWD. In vitro studies showed a significant variation in VWF levels in 9 different batches. The median (range) values (in IU\/mL) were 1.10 (0.98-1.30) for FVIII:C, 1.34 (0.95-1.61) for VWF:Ag, 0.60 (0.27-1.08) for VWF:CBA and 0.73 (0.59-0.94) for VWF:RCo. The relatively low VWF activity is mainly due to the lack of high molecular weight multimers (HMWM), as determined by electrophoresis. A pharmacokinetic study showed, based on a content of FVIII:C of 1 U\/mL, in vivo recoveries (%) of 106 (56-150) (median and range) for FVIII:C, 105 (62-187) for VWF:Ag, 25 (7-41) for VWF:CBA and 43 (11-76) for VWF:RCo. Half-lives were 14.1 h (7.4-36.9) for FVIII:C, 10.8 h (7.7-26.2) for VWF:Ag, 15.3 h (7.8-44.6) for VWF:CBA and 16.4 h (4.2-26.5) for VWF:RCo. In a clinical study efficacy was determined after infusion given before surgery or dental extractions in ten patients. In two patients the hemostatic response was classified as inadequate. In conclusion, there is a wide variability in VWF concentration and activity in various batches of Immunate\u00ae. In the clinical study in which the dosage was based on FVIII:C contents of the concentrate, two out of ten patients had an insufficient haemostatic response. Therefore dosing of Immunate dosing should not be based on FVIII:C levels, but should be based on VWF activity of the individual batches. Future studies using a VWF activity-guided dosage regimen have to be performed to establish the efficacy of Immunate in the treatment of von Willebrand disease.<\/jats:p>","DOI":"10.1160\/th04-02-0107","type":"journal-article","created":{"date-parts":[[2004,6,4]],"date-time":"2004-06-04T03:04:23Z","timestamp":1086318263000},"page":"67-74","source":"Crossref","is-referenced-by-count":6,"title":["In vitro studies, pharmacokinetic studies and clinical use of a high purity double virus inactivated FVIII\/VWF concentrate (Immunate) in the treatment of von Willebrand disease"],"prefix":"10.1160","volume":"92","author":[{"given":"Kristien","family":"Ver Elst","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huub","family":"van Vliet","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mies","family":"Kappers-Klunne","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"Leebeek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"194","published-online":{"date-parts":[[2017,11,29]]},"container-title":["Thrombosis and Haemostasis"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1160\/TH04-02-0107.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2018,10,24]],"date-time":"2018-10-24T16:41:27Z","timestamp":1540399287000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1160\/TH04-02-0107"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2004]]},"references-count":0,"journal-issue":{"issue":"07","published-online":{"date-parts":[[2017,11,29]]},"published-print":{"date-parts":[[2004]]}},"URL":"https:\/\/doi.org\/10.1160\/th04-02-0107","relation":{},"ISSN":["0340-6245","2567-689X"],"issn-type":[{"type":"print","value":"0340-6245"},{"type":"electronic","value":"2567-689X"}],"subject":[],"published":{"date-parts":[[2004]]}}}