Open Label Phase 3 Study of NABI-IGIV 10% [(HUMAN)] In Subjects With Primary Immune Deficiency Disorders (PIDD)

2010-07-15 17:00:00 | BioPortfolio


The purpose of this study is to determine if NABI-IGIV (10%) is safe and effective in preventing serious bacterial infections in the treatment of patients with primary immune deficiency disorders when compared to historical control data. A subgroup of study patients will also have pharmacokinetic evaluations performed.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Primary Immune Deficiency Disorders




University of Alabama
United States




Biotest Pharmaceuticals Corporation

Results (where available)

View Results


Published on BioPortfolio: 2010-07-15T17:00:00-0400

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Medical and Biotech [MESH] Definitions

Disorders characterized by abnormal proliferation of primary cells of the immune system or by excessive production of immunoglobulins.

Compound used for therapy of thiamine deficiency. It has also been suggested for several non-deficiency disorders but has not yet proven useful.

Various conditions with the symptom of HEADACHE. Headache disorders are classified into major groups, such as PRIMARY HEADACHE DISORDERS (based on characteristics of their headache symptoms) and SECONDARY HEADACHE DISORDERS (based on their etiologies). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)

A nutritional condition produced by a deficiency of proteins in the diet, characterized by adaptive enzyme changes in the liver, increase in amino acid synthetases, and diminution of urea formation, thus conserving nitrogen and reducing its loss in the urine. Growth, immune response, repair, and production of enzymes and hormones are all impaired in severe protein deficiency. Protein deficiency may also arise in the face of adequate protein intake if the protein is of poor quality (i.e., the content of one or more amino acids is inadequate and thus becomes the limiting factor in protein utilization). (From Merck Manual, 16th ed; Harrison's Principles of Internal Medicine, 12th ed, p406)

Disorders of the AUTONOMIC NERVOUS SYSTEM occurring as a primary condition. Manifestations can involve any or all body systems but commonly affect the BLOOD PRESSURE and HEART RATE.

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