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

This study has been completed.
Sponsor:
Information provided by:
CSL Behring
ClinicalTrials.gov Identifier:
NCT00168012
First received: September 12, 2005
Last updated: February 10, 2011
Last verified: February 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   3 Years to 70 Years
Genders Eligible for Study:   Both
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:
Click here to request more information about this study  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00168012     History of Changes
Other Study ID Numbers: ZLB04_005CR
Study First Received: September 12, 2005
Last Updated: February 10, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on May 23, 2013