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

NCT03339778 | Completed

• 1 other identifier: IIS201401-PID
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Immunodeficiency

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• 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])

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

• Safety evaluations (Complete Metabolic profile[CMP])

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

• Safety evaluations (IgG trough level)

  Screening and prior to last infusion up to 24 weeks

Eligibility Criteria

• Age: 10 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosis of PID - specifically common variable immunodeficiency (CVID)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IMMUNOe Research Centers: lead

Related Publications (4)

• Geha RS, Notarangelo LD, Casanova JL, Chapel H, Conley ME, Fischer A, Hammarstrom 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. doi: 10.1016/j.jaci.2007.08.053.

  PMID: 17952897 BACKGROUND

• 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.

  PMID: 19571563 BACKGROUND

• 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(Suppl 2):2-5. doi: 10.1111/j.1365-2249.2011.04387.x.

  PMID: 21466545 BACKGROUND

• 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.

  PMID: 21276714 BACKGROUND

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Isaac Melamed, MD

  IMMUNOe Research Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: November 13, 2017
• Study Start: June 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: September 1, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-11