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Home > "R" Clinical Trials Conditions > Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome  Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome
Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome
For Condition: Guillain-Barre Syndrome
Status: Suspended
Sponsor(s): FDA Office of Orphan Products Development , Emory University
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: /17 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Guillain-Barre syndrome (GBS): Progressive weakness of two or more limbs; Absence or reduced tendon reflexes; No atypical symptoms of GBS (e.g., Miller-Fisher variant); No pure sensory neuropathy; No prior history of GBS Disability at least grade 3 according to Guillain-Barre Study Group grading scale (unable to walk 5 meters without assistance); Must not have improvement of one or more disability grades prior to randomization in this study No paresthesias, numbness, or weakness that began more than 14 days before randomization in this study No CNS involvement --Prior/Concurrent Therapy-- Biologic therapy: No prior treatment with plasmapheresis or infusion of human immunoglobulin (IVIg) Endocrine therapy: No concurrent corticosteroids or other immunosuppressants (except for concurrent medical conditions, e.g., asthma) Radiotherapy: Not specified Surgery: Not specified Other: No concurrent mechanical ventilation --Patient Characteristics-- Age: Under 18 but with at least 3 months of independent walking Hematopoietic: Cerebrospinal fluid leukocyte count less than 50/mm3 Hepatic: No liver failure Renal: No kidney failure Neurological: No other major neurologic diseases, other neuromuscular disorders, or cerebral palsy Other: HIV negative; No contraindications to plasmapheresis or IVIg; No severe uncontrolled infection; No known IgA hypersensitivity; No other preexisting disease that would interfere with assessment of disability grades; No other causes of acquired weakness (e.g., poliomyelitis, botulism, or other etiologies); No diabetes; Not pregnant
Total Enrollment: 170
Location and Contact Information:
Overall Study Official:
JohnSladky, Study Chair, Emory University
Additional Information:
Study ID Numbers: 199/13444; EUSM-076-97,EUSM-FDR001265
Study Start Date: July 1995
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004833
Other Guillain-Barre Syndrome Studies:
1. Assessment of Chronic Guillain-Barre Syndrome Improvement with Use of 4-aminopyridine
2. Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome
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Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome
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