{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,10,31]],"date-time":"2023-10-31T06:11:00Z","timestamp":1698732660126},"reference-count":9,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2012,1,18]],"date-time":"2012-01-18T00:00:00Z","timestamp":1326844800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2012,7]]},"abstract":"<jats:p><jats:bold>Summary.\u2002<\/jats:bold> The aim of this open\u2010label, multicentre and multinational post\u2010marketing surveillance was to investigate clinical effectiveness, safety and tolerability of a plasma\u2010derived and vWF containing factor VIII product (FVIII\/VWF) in patients with severe haemophilia A. Long\u2010term effectiveness, safety and tolerability were investigated in a total of 109 haemophilia A patients treated for prophylaxis or on\u2010demand, as required. Interim data collected until June 2010 are presented. Most patients (99\/109; 90.8%) were previously treated patients (PTPs). Mean observation period was 82.6\u2003months. Overall, patients received 105 131 425\u2003IU haemoctin SDH during 68 624 administrations. Each patient was given a mean of 635.4 injections, whereby about half of the administrations were given for treatment of bleeding episodes (46.9%) and the other administrations for prophylactic reasons (53.1%). Patients on prophylaxis had a median of 0.8 bleeding episodes per month. The expected therapeutic effect was reached in 99.3% of treatments. The incidence of clinically relevant inhibitor formation in patients with severe haemophilia (FVIII activity\u2003\u2264\u20031%) was 1.2% for PTPs. One previously untreated patient with severe haemophilia had a clinically relevant transient inhibitor. No treatment related transmissions of hepatitis A, B and C and HIV 1\/2 were observed. German patients had a higher extent of exposure and experienced less bleeding episodes than Hungarian patients. In conclusion, haemoctin SDH was effective, safe and well tolerated in long\u2010term prophylaxis and treatment on demand.<\/jats:p>","DOI":"10.1111\/j.1365-2516.2011.02738.x","type":"journal-article","created":{"date-parts":[[2012,1,18]],"date-time":"2012-01-18T10:18:24Z","timestamp":1326881904000},"page":"496-502","source":"Crossref","is-referenced-by-count":4,"title":["Interim data on long\u2010term efficacy, safety and tolerability of a plasma\u2010derived factor VIII concentrate in 109 patients with severe haemophilia A"],"prefix":"10.1111","volume":"18","author":[{"given":"L.","family":"NEMES","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H.","family":"POLLMANN","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T.","family":"BECKER","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,1,18]]},"reference":[{"key":"e_1_2_8_2_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-2002-32667"},{"key":"e_1_2_8_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199401063300108"},{"key":"e_1_2_8_4_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2005.01114.x"},{"key":"e_1_2_8_5_2","unstructured":"European Medicines Agency (EMA).Note for guidance on the clinical investigation of plasma derived factor VIII and IX products October 19 2000 CPMP\/BPWG\/198\/95 London."},{"key":"e_1_2_8_6_2","unstructured":"European Commission.Directive 2001\/20\/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Available athttp:\/\/ec.europa.eu\/enterprise\/sectors\/pharmaceuticals\/files\/eudralex\/vol\u20101\/8 dir_2001_20\/dir_2001_20_en.pdf. Accessed January 2 2012."},{"key":"e_1_2_8_7_2","doi-asserted-by":"crossref","unstructured":"KasperCK AledortL AronsonDet\u00a0al.Proceedings: A more uniform measurement of factor VIII inhibitors.Thromb Diath Haemorrh1975;34:612.","DOI":"10.1055\/s-0038-1651380"},{"key":"e_1_2_8_8_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2516.1999.00300.x"},{"key":"e_1_2_8_9_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2516.2003.00780.x"},{"key":"e_1_2_8_10_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-0038-1651565"}],"container-title":["Haemophilia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fj.1365-2516.2011.02738.x","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/j.1365-2516.2011.02738.x","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,30]],"date-time":"2023-10-30T15:01:13Z","timestamp":1698678073000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1365-2516.2011.02738.x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,1,18]]},"references-count":9,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2012,7]]}},"alternative-id":["10.1111\/j.1365-2516.2011.02738.x"],"URL":"https:\/\/doi.org\/10.1111\/j.1365-2516.2011.02738.x","archive":["Portico"],"relation":{},"ISSN":["1351-8216","1365-2516"],"issn-type":[{"value":"1351-8216","type":"print"},{"value":"1365-2516","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,1,18]]}}}