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

Primary Immunodeficiency Diseases Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immunodeficiency Diseases

• NCT number: NCT01012323
• Study type: Interventional
• Source: Octapharma
• Status: Completed
• Phase: Phase 3
• Start date: November 2009
• Completion date: August 2012