A prospective controlled crossover trial of a new heat-treated intravenous immunoglobulin. NLM AIDSLINE Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

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A prospective controlled crossover trial of a new heat-treated intravenous immunoglobulin.

Clin Exp Immunol. 1995 Jan;99(1):10-5. Unique Identifier : AIDSLINE MED/95112439
Zuhrie SR; Webster AD; Davies R; Fay AC; Wallington TB; Immunodeficiency Research Group, Clinical Research Centre,; Harrow, UK.

Abstract: Twenty-one patients with primary immunoglobulin deficiency were enrolled in a crossover study to test the efficacy and safety of Alphaglobin in comparison with the licensed preparations Sandoglobulin and Gamimune. There was no statistical difference in these parameters between Alphaglobin and Sandoglobulin/Gamimune. The level of total serum IgG and specific IgG to pneumococcal polysaccharides was similar in individual patients when they were receiving Alphaglobin or one of the other products. Transient increases in serum alanine transferase occurred in five patients on Sandoglobulin/Gamimune and two patients on Alphaglobin. Some patients showed a rise in total serum IgM afterwards, indicating a response to infection. However, serum hepatitis C virus (HCV) RNA was not found during the alanine transferase (ALT) rises, and IgM antibody to hepatitis A virus (HAV) was negative afterwards. We conclude that Alphaglobin is a safe, well tolerated and clinically efficacious treatment for patients with primary antibody deficiency.
Keywords: Adult Agammaglobulinemia/CONGENITAL/*THERAPY Aged Alanine Aminotransferase/BLOOD Common Variable Immunodeficiency/*THERAPY Comparative Study Cross-Over Studies Female Human IgG/BLOOD Immunoglobulins, Intravenous/*THERAPEUTIC USE Male Middle Age Prospective Studies Treatment Outcome CLINICAL TRIAL CONTROLLED CLINICAL TRIAL JOURNAL ARTICLEKWDadultagammaglobulinemia/congenital/KWDtherapyagedalanineaminotransferase/bloodcommonvariableimmunodeficiency/KWDtherapycomparativestudycross-overstudiesfemalehumanigg/bloodimmunoglobulins,intravenous/KWDtherapeuticusemalemiddleageprospectivestudiestreatmentoutcomeclinicaltrialcontrolledclinicaltrialjournalarticle
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M9540678

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