Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-05 @ 9:22 PM
Study NCT ID:
NCT00004833
Status:
TERMINATED
Last Update Posted:
2015-04-07
First Post:
2000-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020275', 'term': 'Guillain-Barre Syndrome'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007136', 'term': 'Immunoglobulins'}], 'ancestors': [{'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 170}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1995-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-09', 'completionDateStruct': {'date': '2002-11'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2000-02-24', 'studyFirstSubmitQcDate': '2000-02-24', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-02-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Guillain-Barre syndrome', 'demyelinating neuropathy', 'neurologic and psychiatric disorders', 'rare disease'], 'conditions': ['Guillain-Barre Syndrome']}, 'descriptionModule': {'briefSummary': 'OBJECTIVES:\n\nI. Compare the efficacy of plasmapheresis and human immunoglobulin infusion in minimizing morbidity and augmenting the pace of recovery in children with Guillain-Barre syndrome.\n\nII. Compare the potential risks, in terms of treatment related side effects and adverse clinical outcome, between these two treatment modalities.', 'detailedDescription': 'PROTOCOL OUTLINE:\n\nThis is a randomized, multicenter study.\n\nPatients are randomized to receive either human immunoglobulin infusion (IVIg) (arm I) or plasmapheresis (arm II).\n\nArm 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.\n\nArm 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.\n\nPatients are followed at weeks 1, 2, 3, 4, 8, 12, and 24.\n\nCompletion date provided represents the completion date of the grant per OOPD records'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'PROTOCOL ENTRY CRITERIA:\n\n--Disease Characteristics--\n\nGuillain-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\n\nDisability 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\n\nNo paresthesias, numbness, or weakness that began more than 14 days before randomization in this study\n\nNo CNS involvement\n\n--Prior/Concurrent Therapy--\n\nBiologic therapy: No prior treatment with plasmapheresis or infusion of human immunoglobulin (IVIg)\n\nEndocrine therapy: No concurrent corticosteroids or other immunosuppressants (except for concurrent medical conditions, e.g., asthma)\n\nRadiotherapy: Not specified\n\nSurgery: Not specified\n\nOther: No concurrent mechanical ventilation\n\n--Patient Characteristics--\n\nAge: Under 18 but with at least 3 months of independent walking\n\nHematopoietic: Cerebrospinal fluid leukocyte count less than 50/mm3\n\nHepatic: No liver failure\n\nRenal: No kidney failure\n\nNeurological: No other major neurologic diseases, other neuromuscular disorders, or cerebral palsy\n\nOther: 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'}, 'identificationModule': {'nctId': 'NCT00004833', 'briefTitle': 'Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome', 'organization': {'class': 'FED', 'fullName': 'FDA Office of Orphan Products Development'}, 'orgStudyIdInfo': {'id': '199/13444'}, 'secondaryIdInfos': [{'id': 'EUSM-076-97'}, {'id': 'EUSM-FDR001265'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Immune globulin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'John T. Sladky', 'role': 'STUDY_CHAIR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}}}}