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Preventing Intravenous Immunoglobulin-associated Adverse Reactions

Information source: University Hospital, Basel, Switzerland
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Immunoglobulin Therapy

Intervention: Infusomat filter (Codan Duofilter-Set V86-P) (Device); IVIG application without filter (Placebo) (Device)

Phase: N/A

Status: Recruiting

Sponsored by: University Hospital, Basel, Switzerland

Official(s) and/or principal investigator(s):
Christoph Hess, MD, Principal Investigator, Affiliation: University Hospital, Basel, Switzerland

Overall contact:
Nathan Cantoni, MD, Phone: 41-061-328-6547, Email: ncantoni@uhbs.ch

Summary

In patients treated with the monoclonal antibody infliximab (Remicade«) - which binds to and

blocks tumor necrosis factor alpha (TNF-alpha) - an infusomat filter is routinely used to

prevent the very same early adverse events observed in individuals receiving intravenous immunoglobulins (IVIG). We recently used such a filter in a patient suffering from malaise and vomiting in the context of an IVIG substitution therapy. In this patient symptoms improved and IVIG-induced complement-activation was reduced (unpublished observation).

Based on this simple observation we hypothesize that this simple and approved filter-system may be efficient in retaining complement-activating IgG aggregates in IVIG-preparations.

This effect may reduce complement activation - and consecutive inflammation - thereby

diminishing adverse events.

In this prospective study we propose to investigate how complement activation and side effects after IVIG infusion relate in individuals receiving conventional (i. e. unfiltered) vs. filtered IVIG-preparations.

Clinical Details

Official title: Prospective Assessment of 0.2 um Pore-sized Filters in Preventing Intravenous Immunoglobulin-associated Adverse Reactions

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Measure activity of complement prior to and after completion of IVIG infusion with/without filter (intervention group/placebo group) in these same patients

Secondary outcome: Monitor adverse reactions experienced by patients receiving IVIG by use of a standardized questionary

Detailed description: Prospective single center study with an observational phase (phase A) and a randomized intervention-phase (phase B), monitoring adverse events and complement activation after IVIG infusion. Patients would be enrolled at the Out-patient Clinic of the Division of Hematology at the Department of Internal Medicine at the University Hospital Basel (USB). Based on the number of patients receiving IVIG at the Division of Hematology of the USB we expect to be able to complete data accrual within 8-10 months.

Inclusion criteria: all patients at the Division of Hematology at the University Hospital of Basel, Switzerland after allogeneic stem cell transplant and older than 18 years which are planed for at least 2 applications of IVIG. The patients are included in this study only by informed consent.

Methods: Side effects of IVIG will be monitored by use of a standardized questionnaire distributed to the nursing staff and the patients (please see attachment). Complement activation will be monitored before and after the IVIG-infusion using standard C3, C4 and CH50 assays. Serum levels of IgA, IgM and IgG will be quantified before and after IVIG-infusion. In phase A of the study we aim at including approximately 40 patients (which would be predicted to include approximately 20 patients with clinical symptoms). In phase B we would randomize these same patients into two groups of similar sizes, the first group receiving standard unfiltered IVIG infusions, the second group receiving 0. 2um filtered IVIG infusions

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All patients at the Division of Hematology at the University Hospital of Basel,

Switzerland after allogeneic stem cell transplant and older than 18 years which are planned for at least 2 applications of IVIG. The patients are included in this study only by informed consent.

Exclusion criteria:

- if inclusion criteria not applicable

Locations and Contacts

Nathan Cantoni, MD, Phone: 41-061-328-6547, Email: ncantoni@uhbs.ch

University Hospital Basel, Switzerland, Basel, Canton Basel-Town 4033, Switzerland; Recruiting
Nathan Cantoni, MD, Phone: 41-061-328-7740, Email: ncantoni@uhbs.ch
Christoph Hess, MD, Phone: 41-061-328-6830, Email: chess@uhbs.ch
Christoph Hess, MD, Principal Investigator
Alois Gratwohl, MD, Sub-Investigator
J├Ârg Halter, MD, Sub-Investigator
Nathan Cantoni, MD, Sub-Investigator
Ingmar Heijnen, MD, Sub-Investigator
Additional Information

Related publications:

Katz U, Achiron A, Sherer Y, Shoenfeld Y. Safety of intravenous immunoglobulin (IVIG) therapy. Autoimmun Rev. 2007 Mar;6(4):257-9. Epub 2006 Aug 28. Review.

Jarius S, Eichhorn P, Albert MH, Wagenpfeil S, Wick M, Belohradsky BH, Hohlfeld R, Jenne DE, Voltz R. Intravenous immunoglobulins contain naturally occurring antibodies that mimic antineutrophil cytoplasmic antibodies and activate neutrophils in a TNFalpha-dependent and Fc-receptor-independent way. Blood. 2007 May 15;109(10):4376-82. Epub 2007 Jan 30.

Starting date: May 2008
Last updated: February 18, 2010

Page last updated: December 08, 2011

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