Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
Primary Purpose
Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Immunoglobulins Intravenous (Human)
Sponsored by
About this trial
This is an interventional treatment trial for Agammaglobulinemia focused on measuring Immunoglobulin intravenous, Agammaglobulinemia, Hypogammaglobulinemia, Common variable immunodeficiency, Immunoglobulin G, Children
Eligibility 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
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00168012
Brief Title
Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
Official Title
An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
CSL Behring
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
Keywords
Immunoglobulin intravenous, Agammaglobulinemia, Hypogammaglobulinemia, Common variable immunodeficiency, Immunoglobulin G, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Immunoglobulins Intravenous (Human)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Rate of acute serious bacterial infections
Title
Number of days out of work/school due to underlying PID
Title
Number of infections
Title
Rate, severity and relationship of all adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Citations:
PubMed Identifier
17479360
Citation
Berger M, Cunningham-Rundles C, Bonilla FA, Melamed I, Bichler J, Zenker O, Ballow M. Carimune NF Liquid is a safe and effective immunoglobulin replacement therapy in patients with primary immunodeficiency diseases. J Clin Immunol. 2007 Sep;27(5):503-9. doi: 10.1007/s10875-007-9096-9. Epub 2007 May 4.
Results Reference
result
Links:
URL
http://www.cslbehring.com/clinical-trials/contact-us.htm?registryRefNum=NCT00168012®istryName=ctgov
Description
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Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
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