Status:
COMPLETED
The Benefit of 5% IVIG for Patients With Primary Immunodeficiency Disorders Who Experience Adverse Events on 10% IVIG Preparations
Lead Sponsor:
IMMUNOe Research Centers
Conditions:
Primary Immunodeficiency
Eligibility:
All Genders
10-75 years
Brief Summary
Patients with primary immunodeficiency disorders (PID) on intravenous immunoglobulin (IVIG) treatment may experience adverse events (AEs). Patients who experience AEs on any 10% IVIG solution will be ...
Detailed Description
Patients with PID require life long immunoglobulin (Ig) replacement therapy with IVIG being the most common form. As more 10% IVIG products are FDA approved, the older and well characterized 5% IVIG p...
Eligibility Criteria
Inclusion
- Participants, or legal guardians with assent by underage children, will sign informed consent/assent and are willing to comply with all aspects of the study
- Diagnosis of CVID according IUIS Expert Committee
- Participants on a 10% product who experience AEs
- Ages between 10 and 75 years of age
- Participants on 10% IVIG therapy every 21±3 days or 28±3 days between 300 - 800 mg/Kg body weight
Exclusion
- Acute infection requiring antibiotic therapy within 7 days prior to visit 1
- Presence of any condition that is likely to interfere with the evaluation of the study medication or satisfactory conduct of the trial
- History of anaphylactic or severe systemic reactions to human immunoglobulin
- IgA deficient patients with antibodies against IgA and a history of hypersensitivity
- Females who are pregnant or lactating
Key Trial Info
Start Date :
June 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03339778
Start Date
June 1 2015
End Date
September 1 2017
Last Update
November 13 2017
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