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

This study has been completed.
ClinicalTrials.gov Identifier:
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

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

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

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:
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
Common variable immunodeficiency
Immunoglobulin G

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