Preventing Intravenous Immunoglobulin-associated Adverse Reactions
Information source: University Hospital, Basel, Switzerland
ClinicalTrials.gov processed this data on August 23, 2015
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)
Sponsored by: University Hospital, Basel, Switzerland
Official(s) and/or principal investigator(s):
Christoph Hess, MD, Principal Investigator, Affiliation: University Hospital, Basel, Switzerland
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improved and IVIG-induced complement-activation was reduced (unpublished observation).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 immunoglobulin G (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.
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
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
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
50% complement hemolytic activity (CH50) assays. Serum levels of immunoglobulin A,
immunoglobulin M and immunoglobulin G 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
Minimum age: 18 Years.
Maximum age: N/A.
- 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.
- if inclusion criteria not applicable
Locations and Contacts
University Hospital Basel, Switzerland, Basel, Canton Basel-Town 4033, Switzerland
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: September 19, 2014