Primary Immunodeficiency Clinical Trial
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
Verified date | November 2017 |
Source | IMMUNOe Research Centers |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | September 2017 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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IMMUNOe Research Centers |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | Safety Evaluations (complete blood count [CBC]) | CBC | Screening and prior to each infusion (six infusions total) up to 24 weeks | |
Secondary | Safety evaluations (Complete Metabolic profile[CMP]) | CMP | Screening and prior to each infusion (six infusions total) up to 24 weeks | |
Secondary | Safety evaluations (IgG trough level) | IgG trough level | Screening and prior to last infusion up to 24 weeks |
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