Back to resultsEfficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
Primary Purpose
IgG Deficiency, Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IV Gamunex 10%
Sponsored by
About this trial
This is an interventional treatment trial for IgG Deficiency focused on measuring Immunodeficiency, Gammaglobulin, IgG subclass deficiency with recurrent infections
Eligibility Criteria
Inclusion Criteria:
- Adult (18 or older) with deficiency in one or more IgG subclasses with documented history of recurrent infections limited to upper or lower respiratory tract, urinary, and/or skin.
Exclusion Criteria:
- Patients with panhypogammaglobulinemia or selective IgA deficiency.
Sites / Locations
- Center for Rheumatic Disease, Allergy, Immunology
Outcomes
Primary Outcome Measures
Lab values ck'ed baseline and with each treatment, and 15 mo. visit
Xray of Chest and sinus baseline and on 12th and last treatment
Clinical assessment baseline, every treatment, and 15 mo.
Secondary Outcome Measures
Patient questionnaires completed by patients, baseline, prior to each treatment, and at 15 month vist.
Full Information
NCT ID
NCT00417573
First Posted
December 28, 2006
Last Updated
December 29, 2006
Sponsor
The Center for Rheumatic Disease, Allergy, & Immunology
Collaborators
Grifols Therapeutics LLC
1. Study Identification
Unique Protocol Identification Number
NCT00417573
Brief Title
Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
Official Title
Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The Center for Rheumatic Disease, Allergy, & Immunology
Collaborators
Grifols Therapeutics LLC
4. Oversight
5. Study Description
Brief Summary
This is the first study, that we are aware of, that will evaluate the efficacy of IgIV in patients with IgG subclass deficiency.
Will provide data for further collaboration in extending study to involve other immunological centers in the United States to study patients with similar disease.
Detailed Description
*10 consenting adults (18 or older) will receive IgIV (Gamunex 10%) monthly at a dose of 400mg/kg body weight IV at 3ml/minute. Comprehensive labs will be monitored at each visit, as well as clinical eval, plus patients will complete a questionnaire each time. There is also a 3 month follow-up visit after completion of therapy. Specific xrays will be done at the beginning and with the last treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgG Deficiency, Infections
Keywords
Immunodeficiency, Gammaglobulin, IgG subclass deficiency with recurrent infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
IV Gamunex 10%
Primary Outcome Measure Information:
Title
Lab values ck'ed baseline and with each treatment, and 15 mo. visit
Title
Xray of Chest and sinus baseline and on 12th and last treatment
Title
Clinical assessment baseline, every treatment, and 15 mo.
Secondary Outcome Measure Information:
Title
Patient questionnaires completed by patients, baseline, prior to each treatment, and at 15 month vist.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (18 or older) with deficiency in one or more IgG subclasses with documented history of recurrent infections limited to upper or lower respiratory tract, urinary, and/or skin.
Exclusion Criteria:
Patients with panhypogammaglobulinemia or selective IgA deficiency.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabih I Abdou, MD, PhD
Organizational Affiliation
Center for Rheumatic Disease, Allergy, Immunology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Rheumatic Disease, Allergy, Immunology
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19218820
Citation
Abdou NI, Greenwell CA, Mehta R, Narra M, Hester JD, Halsey JF. Efficacy of intravenous gammaglobulin for immunoglobulin G subclass and/or antibody deficiency in adults. Int Arch Allergy Immunol. 2009;149(3):267-74. doi: 10.1159/000199723. Epub 2009 Feb 12.
Results Reference
derived
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Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
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