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

安全性，%20耐受性，%20功效，%20AND%20生物%20HALF%20LIFE%20OF%2010%%20GAMMAGARD-SD

• 批准号: 6274002
• 负责人: RICHARD I SCHIFF
• 金额: $ 2.88万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6274002
• 关键词: clinical research; dosage; drug quality /standard; drug screening /evaluation; gamma globulin; human subject; human therapy evaluation; passive immunization

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.

目的：这是一项随机双盲研究，比较两种药物的安全性。 和患者对许可的IGIV产品10%的Gammagard-SD的接受度， 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，自1981年以来已有10家获得许可，其中7家 目前都是可用的。免疫球蛋白预防儿童感染的效果观察 原发体液免疫紊乱的患者是被广泛接受的， 尽管从未进行过受控的双盲研究。一个 将IGIV与安慰剂进行比较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，努力的重点是开发 具有更高安全性的产品，特别是关于 传播丙型肝炎等病毒感染。这项研究建议 比较一种新批准的10%溶剂/洗涤剂的安全性和有效性 IGIV制剂，Gammagard-SD为许可制剂，10%Gamimune。 N-Gammagard-SD是一种无菌、无防腐剂、冷冻干燥的制剂 百特生产的未经修饰的人多价免疫球蛋白 HealthCard Corporation，Hyland部门..它是由ISG制造的 从至少1000名捐赠者中选出。捐赠者接受艾滋病毒，乙肝表面抗原检测， 丙型肝炎抗体和丙氨酸氨基转移酶升高 掉进池子里。ISG是通过相同的Cohn分馏过程制备的 用于所有当前许可的产品。科恩分数III 上清液经过病毒灭活步骤，该步骤包括 用溶剂(0.3%磷酸三正丁酯)和两种洗涤剂处理， 氧乙烯醇9(Triton X-100)和聚山梨酸酯80(吐温80) 类似于纽约血液中心开发并目前使用的 另一种获得许可的IGIV制剂和其他血液产品。之后 添加溶剂和洗涤剂溶液进行处理以去除 除了微量的添加剂外，所有的添加剂。最终的冻干产品， 当重组为5%免疫球蛋白时，含有0.3gm/dl人白蛋白，0.15M 氯化钠，0.11M葡萄糖，0.3M甘氨酸，0.2g/dl聚乙二醇，以及 免疫球蛋白M和免疫球蛋白A的残留水平。Gammagard-SD的IgA水平是最低的之一 任何产品的级别。