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

• Sponsor: IMMUNOe Research Centers (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03339778
• Collaborator: (none)
• Enrollment: 15
• Actual Duration (Months): 27

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Primary Immunodeficiency

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 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 Design

• Study Type: Observational
• Actual Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Sep 1, 2017

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

2. Safety Evaluations (complete blood count [CBC]) [Screening and prior to each infusion (six infusions total) up to 24 weeks]

   CBC

3. Safety evaluations (Complete Metabolic profile[CMP]) [Screening and prior to each infusion (six infusions total) up to 24 weeks]

   CMP

4. Safety evaluations (IgG trough level) [Screening and prior to last infusion up to 24 weeks]

   IgG trough level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• IMMUNOe Research Centers

Investigators

• Principal Investigator: Isaac Melamed, MD, IMMUNOe Research Centers

Study Documents (Full-Text)

None provided.

More Information

Publications

• Deane S, Selmi C, Naguwa SM, Teuber SS, Gershwin ME. Common variable immunodeficiency: etiological and treatment issues. Int Arch Allergy Immunol. 2009;150(4):311-24. doi: 10.1159/000226232. Epub 2009 Jul 1. Review. Erratum in: Int Arch Allergy Immunol. 2010;151(4):284. Dosage error in article text.
• Geha RS, Notarangelo LD, Casanova JL, Chapel H, Conley ME, Fischer A, Hammarström L, Nonoyama S, Ochs HD, Puck JM, Roifman C, Seger R, Wedgwood J; International Union of Immunological Societies Primary Immunodeficiency Diseases Classification Committee. Primary immunodeficiency diseases: an update from the International Union of Immunological Societies Primary Immunodeficiency Diseases Classification Committee. J Allergy Clin Immunol. 2007 Oct;120(4):776-94.
• Kaveri SV, Maddur MS, Hegde P, Lacroix-Desmazes S, Bayry J. Intravenous immunoglobulins in immunodeficiencies: more than mere replacement therapy. Clin Exp Immunol. 2011 Jun;164 Suppl 2:2-5. doi: 10.1111/j.1365-2249.2011.04387.x. Review.
• Maarschalk-Ellerbroek LJ, Hoepelman IM, Ellerbroek PM. Immunoglobulin treatment in primary antibody deficiency. Int J Antimicrob Agents. 2011 May;37(5):396-404. doi: 10.1016/j.ijantimicag.2010.11.027. Epub 2011 Jan 26. Review.

• Responsible Party: IMMUNOe Research Centers
• ClinicalTrials.gov Identifier: NCT03339778
• Other Study ID Numbers: IIS201401-PID
• First Posted: Nov 13, 2017
• Last Update Posted: Nov 13, 2017
• Last Verified: Nov 1, 2017

• Additional relevant MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes

Study Results

No Results Posted as of Nov 13, 2017