{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T08:38:10Z","timestamp":1778661490177,"version":"3.51.4"},"reference-count":38,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2011,3,29]],"date-time":"2011-03-29T00:00:00Z","timestamp":1301356800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vox Sanguinis"],"published-print":{"date-parts":[[2011,8]]},"abstract":"<jats:p><jats:bold>Background and Objectives\u2002<\/jats:bold> In the production process of a new 5% liquid intravenous immunoglobulin (IVIG\u2010L) product (Nanogam<jats:sup>\u00ae<\/jats:sup>), a combined pepsin\/pH 4\u00b74 treatment\/15\u2010nm filtration (pH 4\u00b74\/15NF) step and a solvent\u2010detergent (SD) treatment step were incorporated to improve the virus inactivating\/reducing capacity of the manufacturing process. Two prospective uncontrolled multicentre studies were performed to evaluate the safety and efficacy of this product.<\/jats:p><jats:p><jats:bold>Materials and Methods\u2002<\/jats:bold> Efficacy, including pharmacokinetics, of IVIG\u2010L was studied for 6\u2003months in 18 primary immunodeficiency (PID) patients, succeeded by a long\u2010term follow\u2010up study (mean 2\u00b72\u2003years, <jats:italic>n<\/jats:italic>\u2003=\u200317). Second, in 24 patients with idiopathic thrombocytopenic purpura (ITP), IVIG\u2010L was studied for efficacy for 14\u2003days. In both studies, adverse events and vital signs were recorded to study safety.<\/jats:p><jats:p><jats:bold>Results\u2002<\/jats:bold> In PID patients treated with IVIG\u2010L, 0\u00b760 and 0\u00b738 severe infections per patient per year were reported during, respectively, the short\u2010term and long\u2010term follow\u2010up. Pharmacokinetic studies resulted in an IgG half\u2010life of 30\u00b79\u2003\u00b1\u200311\u00b73\u2003days and a mean IgG trough level of 6\u00b78\u2003\u00b1\u20031\u00b72\u2003g\/l. In the ITP study, all patients showed an increase in platelet counts after infusion with IVIG\u2010L, and 20\/24 patients responded with a platelet count &gt;\u200350\u2003\u00d7\u200310<jats:sup>9<\/jats:sup>\/l (83\u00b73%) within 1\u2003week. IVIG\u2010L infusions did not cause clinical relevant changes in laboratory parameters or vital signs.<\/jats:p><jats:p><jats:bold>Conclusions\u2002<\/jats:bold> In clinical studies, IVIG\u2010L (Nanogam<jats:sup>\u00ae<\/jats:sup>) demonstrated to be efficacious, well tolerated and safe.<\/jats:p>","DOI":"10.1111\/j.1423-0410.2011.01476.x","type":"journal-article","created":{"date-parts":[[2011,3,29]],"date-time":"2011-03-29T10:37:36Z","timestamp":1301395056000},"page":"138-146","source":"Crossref","is-referenced-by-count":17,"title":["Efficacy and safety of a nanofiltered liquid intravenous immunoglobulin product in patients with primary immunodeficiency and idiopathic thrombocytopenic purpura"],"prefix":"10.1111","volume":"101","author":[{"given":"J. W. M.","family":"van der Meer","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R. 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