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

IMMUNOe Research Centers15 enrolled

Overview

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.

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%.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Primary Immunodeficiency

Eligibility

Sex: ALLMin age: 10 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The change in the number of AEs post-infusion between any 10% IVIG product and octagam 5%

Time frame: AEs will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks

Secondary Outcomes

The change in levels of inflammatory biomarkers associated with AEs between any 10% IVIG and octagam 5%

Time frame: 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

Time frame: Screening and prior to each infusion (six infusions total) up to 24 weeks

Safety evaluations (Complete Metabolic profile[CMP])

CMP

Time frame: Screening and prior to each infusion (six infusions total) up to 24 weeks

Safety evaluations (IgG trough level)

IgG trough level

Time frame: Screening and prior to last infusion up to 24 weeks

Data from ClinicalTrials.gov

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