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

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ClinicalTrials.gov Identifier: NCT00168012
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 11, 2011
Sponsor:
Information provided by:
CSL Behring

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.


Condition or disease Intervention/treatment Phase
Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency Drug: Immunoglobulins Intravenous (Human) Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)
Study Start Date : September 2004
Actual Study Completion Date : September 2005





Primary Outcome Measures :
  1. 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 :
  1. Rate of acute serious bacterial infections
  2. Number of days out of work/school due to underlying PID
  3. Number of infections
  4. Rate, severity and relationship of all adverse events


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Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: NCT00168012     History of Changes
Other Study ID Numbers: ZLB04_005CR
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: February 2011

Keywords provided by CSL Behring:
Immunoglobulin intravenous
Agammaglobulinemia
Hypogammaglobulinemia
Common variable immunodeficiency
Immunoglobulin G
Children

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Common Variable Immunodeficiency
Agammaglobulinemia
IgG Deficiency
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Dysgammaglobulinemia
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs