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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

Summary

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

Conditions

Primary Immune Deficiency Disorders

Intervention

Nabi-IGIV

Location

University of Alabama
Birmingham
Alabama
United States
35294

Status

Completed

Source

Biotest Pharmaceuticals Corporation

Results (where available)

View Results

Links

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.

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