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Clinical Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Patients With Primary Immunodeficiency Diseases

2014-07-23 21:11:49 | BioPortfolio

Summary

The purpose of this study is to determine the efficacy of NewGam in preventing serious bacterial infections, and on quality of life. The safety and pharmacokinetic profile of NewGam will also be evaluated.

Description

NewGam is a new 10% human normal immunoglobulin (IVIG) solution developed by Octapharma for intravenous administration. It is supplied as a liquid formulation ready to use. IVIG has proved to be useful in a variety of clinical conditions other than for replacement of immunoglobulins, in which IVIG exhibits an immunomodulatory effect. Children and adults with PID have an increased risk of getting recurrent bacterial and viral infections that typically attack the respiratory tract (sinusitis, bronchitis, pneumonia) but can also affect the gastrointestinal tract (gastroenteritis). They can be severe and can lead to substantial morbidity. Responses to antibacterial therapy are often poor. At present, most primary immune deficiencies are not curable, but IVIGs have been shown to decrease the total number of severe infections and the duration of hospitalization.

Study Design

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

Conditions

Primary Immunodeficiency Diseases

Intervention

NewGam, NewGam

Location

Dr. Alan Knutsen
St. Louis
Missouri
United States
63104

Status

Recruiting

Source

Octapharma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:49-0400

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