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Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome

2014-07-23 21:56:49 | BioPortfolio

Summary

OBJECTIVES:

I. Compare the efficacy of plasmapheresis and human immunoglobulin infusion in minimizing morbidity and augmenting the pace of recovery in children with Guillain-Barre syndrome.

II. Compare the potential risks, in terms of treatment related side effects and adverse clinical outcome, between these two treatment modalities.

Description

PROTOCOL OUTLINE:

This is a randomized, multicenter study.

Patients are randomized to receive either human immunoglobulin infusion (IVIg) (arm I) or plasmapheresis (arm II).

Arm I patients receive liquid heat-treated IVIg for 4 days starting on day 1 and then another single infusion of IVIg on day 7, 8, or 9.

Arm II patients receive serial plasmapheresis treatments. The first exchange is given on day 1 and the remaining exchanges are given over the next 5-10 days.

Patients are followed at weeks 1, 2, 3, 4, 8, 12, and 24.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Conditions

Guillain-Barre Syndrome

Intervention

Immune globulin

Status

Suspended

Source

FDA Office of Orphan Products Development

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:56:49-0400

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