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Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 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
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 Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10 Key Exclusion Criteria: Allergic reactions to immunoglobulins or other blood products Steroids (oral and parenteral, daily ≥0.15 mg of prednisone equivalent/kg/day History of cardiac insufficiency Epilepsia

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship.

    Secondary Outcome Measures

    Rate of acute serious bacterial infections
    Number of days out of work/school due to underlying PID
    Number of infections
    Rate, severity and relationship of all adverse events

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    February 10, 2011
    Sponsor
    CSL Behring
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00168012
    Brief Title
    Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
    Official Title
    An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    CSL Behring

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to demonstrate the effect of IVIG-F10 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 IVIG-F10 are studied.

    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
    Non-Randomized
    Enrollment
    42 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Immunoglobulins Intravenous (Human)
    Primary Outcome Measure Information:
    Title
    Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship.
    Secondary Outcome Measure Information:
    Title
    Rate of acute serious bacterial infections
    Title
    Number of days out of work/school due to underlying PID
    Title
    Number of infections
    Title
    Rate, severity and relationship of all adverse events

    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 Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10 Key Exclusion Criteria: Allergic reactions to immunoglobulins or other blood products Steroids (oral and parenteral, daily ≥0.15 mg of prednisone equivalent/kg/day History of cardiac insufficiency Epilepsia

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17479360
    Citation
    Berger M, Cunningham-Rundles C, Bonilla FA, Melamed I, Bichler J, Zenker O, Ballow M. Carimune NF Liquid is a safe and effective immunoglobulin replacement therapy in patients with primary immunodeficiency diseases. J Clin Immunol. 2007 Sep;27(5):503-9. doi: 10.1007/s10875-007-9096-9. Epub 2007 May 4.
    Results Reference
    result
    Links:
    URL
    http://www.cslbehring.com/clinical-trials/contact-us.htm?registryRefNum=NCT00168012&registryName=ctgov
    Description
    Click here to request more information about this study

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    Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)

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