Clinical Trial: Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title:
Brief 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.
Detailed Summary:
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.
Completion date provided represents the completion date of the grant per OOPD records
Sponsor: Emory University
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: FDA Office of Orphan Products Development
Dates:
Date Received: February 24, 2000
Date Started: July 1995
Date Completion: November 2002
Last Updated: April 6, 2015
Last Verified: September 2002