Back to resultsEfficacy and Safety of Intravenous Immunoglobulin IgPro10 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 Patients who have received stable IVIG therapy at 3- or 4-weekly intervals for at least 6 months Key Exclusion Criteria: Newly diagnosed PID Allergic reactions to immunoglobulins or other blood products Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs Concomitant diseases such as hypoalbuminemia, protein-losing enteropathies, kidney diseases with proteinuria, malignancies of lymphoid cells (e.g. lymphocytic leukemia), and recent history of migraine History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IgPro10
Arm Description
Outcomes
Primary Outcome Measures
Annualized rate of acute serious bacterial infections
Secondary Outcome Measures
Number of infections
Number of days out of work / school due to underlying PID
Adverse events temporally associated with study drug infusion
Trough levels of total IgG serum concentrations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00168025
Brief Title
Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
Official Title
A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to demonstrate the effect of IgPro10 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 IgPro10 are studied.
A part of the patients are participating in a pharmacokinetic substudy.
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
N/A
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IgPro10
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Immunoglobulins Intravenous (Human)
Primary Outcome Measure Information:
Title
Annualized rate of acute serious bacterial infections
Secondary Outcome Measure Information:
Title
Number of infections
Title
Number of days out of work / school due to underlying PID
Title
Adverse events temporally associated with study drug infusion
Title
Trough levels of total IgG serum concentrations
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
Patients who have received stable IVIG therapy at 3- or 4-weekly intervals for at least 6 months
Key Exclusion Criteria:
Newly diagnosed PID
Allergic reactions to immunoglobulins or other blood products
Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs
Concomitant diseases such as hypoalbuminemia, protein-losing enteropathies, kidney diseases with proteinuria, malignancies of lymphoid cells (e.g. lymphocytic leukemia), and recent history of migraine
History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Program Director
Organizational Affiliation
CSL Behring
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20217199
Citation
Sleasman JW, Duff CM, Dunaway T, Rojavin MA, Stein MR. Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates. J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 Mar 10.
Results Reference
background
PubMed Identifier
18814020
Citation
Stein MR, Nelson RP, Church JA, Wasserman RL, Borte M, Vermylen C, Bichler J; IgPro10 in PID study group. Safety and efficacy of Privigen, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. J Clin Immunol. 2009 Jan;29(1):137-44. doi: 10.1007/s10875-008-9231-2. Epub 2008 Sep 24.
Results Reference
result
Links:
URL
http://www.cslbehring.com/clinical-trials/contact-us.htm?registryRefNum=NCT00168025®istryName=ctgov
Description
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Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
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