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Preventing Intravenous Immunoglobulin-associated Adverse Reactions

NCT00675805 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-09-22

No results posted yet for this study

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 In this patient symptoms improved and IVIG-induced complement-activation was reduced (unpublished observation).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 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.

Conditions

  • Immunoglobulin Therapy

Interventions

DEVICE

Infusomat filter (Codan Duofilter-Set V86-P)

An 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 during application of intravenous immunoglobulins.

DEVICE

IVIG application without filter (Placebo)

Application Intravenous immunoglobulins without filter (Placebo)

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Christoph Hess, MD · University Hospital, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00675805 on ClinicalTrials.gov