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

NCT00168025 | Completed Phase 3

• 1 other identifier: ZLB03_002CR
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Agammaglobulinemia; IgG Deficiency; Common Variable Immunodeficiency

Keywords

Immunoglobulin Intravenous; Agammaglobulinemia; Hypogammaglobulinemia; Common variable immunodeficiency; Immunoglobulin G; Children

Outcome Measures

Primary Outcomes (1)

• Annualized rate of acute serious bacterial infections

Secondary Outcomes (4)

• 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

Study Arms (1)

IgPro10

EXPERIMENTAL

Drug: Immunoglobulins Intravenous (Human)

Interventions

Immunoglobulins Intravenous (Human) DRUG

IgPro10

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary immunodeficiency
• Patients who have received stable IVIG therapy at 3- or 4-weekly intervals for at least 6 months

You may not qualify if:

• 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

Sponsors & Collaborators

• CSL Behring: lead

Related Publications (2)

• Sleasman JW, Duff CM, Dunaway T, Rojavin MA, Stein MR. Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates. J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 Mar 10.

  PMID: 20217199 BACKGROUND

• Stein MR, Nelson RP, Church JA, Wasserman RL, Borte M, Vermylen C, Bichler J; IgPro10 in PID study group. Safety and efficacy of Privigen, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. J Clin Immunol. 2009 Jan;29(1):137-44. doi: 10.1007/s10875-008-9231-2. Epub 2008 Sep 24.

  PMID: 18814020 RESULT

MeSH Terms

Conditions

Agammaglobulinemia; IgG Deficiency; Common Variable Immunodeficiency

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Dysgammaglobulinemia

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Program Director

  CSL Behring

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: September 1, 2004
• Study Completion: March 1, 2006
• Last Updated: June 6, 2012

Record last verified: 2012-06