The Benefit of 5% IVIG for Patients With Primary Immunodeficiency Disorders Who Experience Adverse Events on 10% IVIG Preparations

Study Overview
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Brief Summary
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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 changed to octagam 5% for six infusions to evaluate the potential benefit for reduction of AEs on a lower concentration IVIG product.

Detailed Description
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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 products are becoming less used. Currently, the standard of care for patients who experience AEs on IVIG is to move to a subcutaneous (SCIG) delivery and product. This study will evaluate the AEs on a 10% product and octagam 5%. The study will enroll 15 patients after an AE on any 10% product who will then be infused with octagam 5% for six infusions. AEs will be documented and compared to the 10% product along with changes in biomarkers. The study data may document another therapeutic option for patients who experience AEs - SCIG and octagam 5%.

Official Title
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An Investigator Driven Observational Study to Determine the Benefit of Octagam 5% for Treatment of Patients Diagnosed With Primary Immunodeficiency Disorders (PID) on Intravenous Immunoglobulin (IVIG) Therapy That Experience Adverse Events (AEs) on Any 10% IVIG Preparation

Conditions
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Primary Immunodeficiency

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the number of AEs post-infusion between any 10% IVIG product and octagam 5% |  | AEs will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in levels of inflammatory biomarkers associated with AEs between any 10% IVIG and octagam 5% |  | Levels will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks | 
| Safety Evaluations (complete blood count [CBC]) | CBC | Screening and prior to each infusion (six infusions total) up to 24 weeks | 
| Safety evaluations (Complete Metabolic profile[CMP]) | CMP | Screening and prior to each infusion (six infusions total) up to 24 weeks | 
| Safety evaluations (IgG trough level) | IgG trough level | Screening and prior to last infusion up to 24 weeks |