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

Primary Purpose

Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Immunoglobulins Intravenous (Human)
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agammaglobulinemia focused on measuring Immunoglobulin Intravenous, Agammaglobulinemia, Hypogammaglobulinemia, Common variable immunodeficiency, Immunoglobulin G, Children

Eligibility Criteria

3 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    IgPro10

    Arm Description

    Outcomes

    Primary Outcome Measures

    Annualized rate of acute serious bacterial infections

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    June 5, 2012
    Sponsor
    CSL Behring
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00168025
    Brief Title
    Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
    Official Title
    A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CSL Behring

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
    Keywords
    Immunoglobulin Intravenous, Agammaglobulinemia, Hypogammaglobulinemia, Common variable immunodeficiency, Immunoglobulin G, Children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    89 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IgPro10
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Immunoglobulins Intravenous (Human)
    Primary Outcome Measure Information:
    Title
    Annualized rate of acute serious bacterial infections
    Secondary Outcome Measure Information:
    Title
    Number of infections
    Title
    Number of days out of work / school due to underlying PID
    Title
    Adverse events temporally associated with study drug infusion
    Title
    Trough levels of total IgG serum concentrations

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Program Director
    Organizational Affiliation
    CSL Behring
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20217199
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18814020
    Citation
    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.
    Results Reference
    result
    Links:
    URL
    http://www.cslbehring.com/clinical-trials/contact-us.htm?registryRefNum=NCT00168025&registryName=ctgov
    Description
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    Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

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