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| Sponsored by: |
University Hospital, Basel, Switzerland |
|---|---|
| Information provided by: | University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier: | NCT00675805 |
Purpose
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 In this patient symptoms improved and IVIG-induced complement-activation was reduced (unpublished observation).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.
| Condition | Intervention |
|---|---|
|
Immunoglobulin Therapy |
Device: Infusomat filter (Codan Duofilter-Set V86-P) Device: IVIG application without filter (Placebo) |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Prospective Assessment of 0.2 um Pore-Sized Filters in Preventing Intravenous Immunoglobulin-Associated Adverse Reactions |
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group I: Active Comparator
IVIG infusion with filter
|
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.
|
|
Group II: Placebo Comparator
IVIG infusion without filter
|
Device: IVIG application without filter (Placebo)
Application Intravenous immunoglobulins without filter (Placebo)
|
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 wil 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 approx. 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contacts and Locations| Contact: Nathan Cantoni, MD | 41-061-328-6547 | ncantoni@uhbs.ch |
| Contact: Christoph Hess, MD | 41-061-328-6830 | chess@uhbs.ch |
| Switzerland, Canton Basel-Town | |
| University Hospital Basel, Switzerland | Recruiting |
| Basel, Canton Basel-Town, Switzerland, 4033 | |
| Contact: Nathan Cantoni, MD 41-061-328-7740 ncantoni@uhbs.ch | |
| Contact: Christoph Hess, MD 41-061-328-6830 chess@uhbs.ch | |
| Principal Investigator: Christoph Hess, MD | |
| Sub-Investigator: Alois Gratwohl, MD | |
| Sub-Investigator: Jörg Halter, MD | |
| Sub-Investigator: Nathan Cantoni, MD | |
| Sub-Investigator: Ingmar Heijnen, MD | |
| Principal Investigator: | Christoph Hess, MD | University Hospital, Basel, Switzerland |
More Information
| Responsible Party: | University Hospital, Basel, Switzerland ( Prof. Christoph Hess, MD ) |
| Study ID Numbers: | IVIG-001 |
| Study First Received: | May 7, 2008 |
| Last Updated: | December 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00675805 History of Changes |
| Health Authority: | Switzerland: Ethikkommission |
|
intravenous immunoglobulin IVIG adverse reactions |
|
Antibodies Immunologic Factors Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunoglobulins |
|
Antibodies Immunologic Factors Immunoglobulins, Intravenous Physiological Effects of Drugs |
Rho(D) Immune Globulin Pharmacologic Actions Immunoglobulins |
