SAFETY, TOLERANCE, EFFICACY, AND BIOLOGICAL HALF LIFE OF 10% GAMMAGARD-SD

目的：这是一项随机、双盲研究， 和患者对许可IGIV产品的可接受性为10% Gammagard-SD， 10%Gamimune.- N. 背景：静脉注射丙种球蛋白（IGIV）制剂已被测试 自1975年以来在美国有10家，自1981年以来有10家获得许可，其中7家 目前可用。 IGIV预防感染的有效性 具有原发性体液免疫紊乱的患者是被广泛接受的， 尽管它从未进行过双盲对照研究。 一 比较IGIV和安慰剂的研究将被认为是不道德的，尽管它 可以将新产品与已获得许可的产品进行比较， 使用. 在过去的几年里，我们的工作重点是开发 安全性更高的产品，特别是在 传播病毒感染，如丙型肝炎。本研究建议， 比较新许可的10%溶剂/清洁剂的安全性和有效性 IGIV制剂，Gammagard-SD至许可制剂，10% Gamimune。 N. Gammagard-SD是一种无菌、无防腐剂的冻干制剂 由巴克斯特生产的未修饰人多价免疫球蛋白 健康卡公司海兰分部 它是由ISG制成的 至少有1000名捐赠者 献血者接受艾滋病毒、HBsAg、 丙型肝炎抗体，并在被接受前ALT水平升高 扔进泳池 ISG通过相同的科恩分馏工艺制备 用于所有当前许可的产品。 科恩分数III 对上清液进行病毒灭活步骤，所述病毒灭活步骤包括 用溶剂（0.3%磷酸三正丁酯）和两种洗涤剂处理， 氧苯聚醇9（Triton X-100）和聚山梨醇酯80（吐温80）， 类似于在纽约血液中心开发的和目前使用的 用于另一种获得许可的IGIV制剂和其他血液制品。 后 加入溶剂和洗涤剂，处理溶液以除去 除了微量的添加剂 最终的冻干产品， 当复溶至5% IgG时，含有0.3 gm/dl人白蛋白，0.15 M NaCl、0.11 M右旋糖、0.3 M甘氨酸、0.2 g/dl聚乙二醇和 IgM和伊加的残留水平。 Gammagard-SD具有最低的伊加之一 任何产品的水平。

Purpose: This was a randomized, double-blind study comparing the safety and patient acceptability of 10% Gammagard-SD to a licensed IGIV product, 10%Gamimune.-N. Background: Intravenous gammaglobulin (IGIV) preparations have been tested in the US since 1975 and ten have been licensed since 1981, seven of which are currently available. The efficacy of IGIV in preventing infections in patients with primary disorders of humoral immunity is well accepted, though it has never been subjected to a controlled double-blind study. A study comparing IGIV to placebo would be considered unethical, though it is possible to compare new products to those that have been licensed for use. In the past several years efforts have focused on developing products with increased safety, especially with regard to the risk of transmitting viral infections such as Hepatitis C. This study proposes to compare the safety and efficacy of a newly licensed 10% solvent/detergent IGIV preparation, Gammagard-SD to a licensed preparation, 10% Gamimune.- N. Gammagard-SD is a sterile, preservative-free, lyophilized preparation of unmodified human polyvalent immunoglobulins manufactured by Baxter Healthcard Corporation, Hyland division.. It is prepared from ISG made from a pool of at least 1000 donors. Donors are tested for HIV, HBsAg, Hepatitis C antibody, and increased levels of ALT before being accepted into the pool. The ISG is prepared by the same Cohn fractionation process used for all of the currently licensed products. The Cohn fraction III supernatant is subjected to a viral inactivation step consisting of treatment with solvent (0.3% tri-n-butyl phosphate) and two detergents, oxtoxynol 9 (Triton X-100) and polysorbate 80 (Tween 80) using a process similar to that developed in the New York Blood Center and currently used for one other licensed IGIV preparation and other blood products. After addition of the solvent and detergents the solution is treated to remove all but trace amounts of the additives. The final lyophilized product, when reconstituted to 5% IgG, contains 0.3 gm/dl human albumin, 0.15 M NaCl, 0.11 M dextrose, 0.3 M glycine, 0.2 g/dl polyethylene glycol, and residual levels of IgM and IgA. Gammagard-SD has one of the lowest IgA levels of any product.