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Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

Information source: CSL Behring
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Agammaglobulinemia; IgG Deficiency; Common Variable Immunodeficiency

Intervention: Immunoglobulins Intravenous (Human) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: CSL Behring

Summary

The purpose of this study is to demonstrate the effect of IgPro10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.

As secondary endpoints the rate of overall infections, the tolerability and safety of IgPro10 are studied.

A part of the patients are participating in a pharmacokinetic substudy.

Clinical Details

Official title: A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Annualized rate of acute serious bacterial infections

Secondary outcome:

Number of infections

Number of days out of work / school due to underlying PID

Adverse events temporally associated with study drug infusion

Trough levels of total IgG serum concentrations

Eligibility

Minimum age: 3 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Key Inclusion Criteria:

- Patients with primary immunodeficiency

- Patients who have received stable IVIG therapy at 3- or 4-weekly intervals for at

least 6 months

Key Exclusion Criteria:

- Newly diagnosed PID

- Allergic reactions to immunoglobulins or other blood products

- Administration of steroids (daily ≥ 0. 15 mg prednisone equivalent/kg/day) or other

immunosuppressive drugs

- Concomitant diseases such as hypoalbuminemia, protein-losing enteropathies, kidney

diseases with proteinuria, malignancies of lymphoid cells (e. g. lymphocytic leukemia), and recent history of migraine

- History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart

failure, severe hypertension

Locations and Contacts

Additional Information

Starting date: September 2004
Last updated: January 5, 2007

Page last updated: March 21, 2008

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