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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168012
First Posted: September 14, 2005
Last Update Posted: February 11, 2011
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.
Information provided by:
CSL Behring
  Purpose

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 Intervention Phase
Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency Drug: Immunoglobulins Intravenous (Human) Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by CSL Behring:

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

Estimated Enrollment: 42
Study Start Date: September 2004
Study Completion Date: September 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Senior)
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00168012     History of Changes
Other Study ID Numbers: ZLB04_005CR
First Submitted: September 12, 2005
First Posted: September 14, 2005
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