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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00168012
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 11, 2011
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

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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

Information from the National Library of Medicine

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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

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:
Layout table for additonal information Identifier: NCT00168012    
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
Common variable immunodeficiency
Immunoglobulin G
Additional relevant MeSH terms:
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IgG Deficiency
Immunologic Deficiency Syndromes
Common Variable Immunodeficiency
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs