Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT04871035
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2021-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010956', 'term': 'Plasmapheresis'}, {'id': 'D010951', 'term': 'Plasma Exchange'}], 'ancestors': [{'id': 'D001781', 'term': 'Blood Component Removal'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D001803', 'term': 'Blood Transfusion'}, {'id': 'D001691', 'term': 'Biological Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-05-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2021-04-28', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score', 'timeFrame': '2 weeks', 'description': 'Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted'}, {'measure': 'Inflammatory Neuropathy Cause and Treatment (INCAT) disability score', 'timeFrame': '2 weeks', 'description': 'Standard clinical score for inflammatory neuropathies.'}, {'measure': 'Oxford Muscle Strength Score (Medical Research Council, MRC)', 'timeFrame': '2 weeks', 'description': 'Standard clinical score for evaluating muscle strength / paresis. Muscle strength will be measured on a scale between 0 (no movement) and 5 (full strength) on 8 pre-defined muscles (one proximal and one distal muscle at each extremity).'}, {'measure': 'Vibration Score', 'timeFrame': '2 weeks', 'description': 'Standard clinical score for evaluation of vibration sensitivity on a scale between 0 and 8, using a 256 tuning fork at 4 predefined spots (processus styloideus radii and malleolus lateralis on both sides).'}], 'secondaryOutcomes': [{'measure': 'Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score', 'timeFrame': '1, 3, and 5 weeks', 'description': 'Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted'}, {'measure': 'Inflammatory Neuropathy Cause and Treatment (INCAT) disability score', 'timeFrame': '1, 3, and 5 weeks', 'description': 'Standard clinical score for inflammatory neuropathies.'}, {'measure': 'Oxford Muscle Strength Score (Medical Research Council, MRC)', 'timeFrame': '1, 3, and 5 weeks', 'description': 'Standard clinical score for evaluating muscle strength / paresis. Muscle strength will be measured on a scale between 0 (no movement) and 5 (full strength) on 8 pre-defined muscles (one proximal and one distal muscle at each extremity).'}, {'measure': 'Vibration Score', 'timeFrame': '1, 3, and 5 weeks', 'description': 'Standard clinical score for evaluation of vibration sensitivity on a scale between 0 and 8, using a 256 tuning fork at 4 predefined spots (processus styloideus radii and malleolus lateralis on both sides).'}, {'measure': 'Hughes Score', 'timeFrame': '1, 2, 3, and 5 weeks', 'description': 'Standard clinical score to quantify disability in Guillain-Barré syndrome'}, {'measure': 'Pain', 'timeFrame': '1, 2, 3, and 5 weeks', 'description': 'Pain quantified on a visual analog scale between 0 (no pain) and 10 (maximum pain).'}, {'measure': 'N20', 'timeFrame': '2 and 5 weeks', 'description': 'N20 latency of nervus medianus (both sides) as measured by somatosensory evoked potentials (SEPs)'}, {'measure': 'P40', 'timeFrame': '2 and 5 weeks', 'description': 'P40 latency of nervus tibialis (both sides) as measured by somatosensory evoked potentials'}, {'measure': 'Nerve Conduction Velocity', 'timeFrame': '2 and 5 weeks', 'description': 'Nerve conduction velocity of clinically affected nerves as measured by electroneurography (ENG)'}, {'measure': 'Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)', 'timeFrame': '1, 2, 3, and 5 weeks', 'description': 'Quality of Life Scale'}, {'measure': 'Immunoglobulin A in serum', 'timeFrame': '1, 2, 3, and 5 weeks', 'description': 'Immunoglobulin A serum concentration'}, {'measure': 'Immunoglobulin A in cerebrospinal fluid (CSF)', 'timeFrame': '2 weeks', 'description': 'Immunoglobulin A concentration in cerebrospinal fluid'}, {'measure': 'Immunoglobulin G in serum', 'timeFrame': '1, 2, 3, and 5 weeks', 'description': 'Immunoglobulin G serum concentration'}, {'measure': 'Immunoglobulin G in cerebrospinal fluid (CSF)', 'timeFrame': '2 weeks', 'description': 'Immunoglobulin G concentration in cerebrospinal fluid'}, {'measure': 'Immunoglobulin M in serum', 'timeFrame': '1, 2, 3, and 5 weeks', 'description': 'Immunoglobulin M serum concentration'}, {'measure': 'Immunoglobulin M in cerebrospinal fluid (CSF)', 'timeFrame': '2 weeks', 'description': 'Immunoglobulin M concentration in cerebrospinal fluid'}, {'measure': 'Interleukin-1', 'timeFrame': '1, 2, 3, and 5 weeks', 'description': 'Interleukin-1 serum concentration'}, {'measure': 'Interleukin-6', 'timeFrame': '1, 2, 3, and 5 weeks', 'description': 'Interleukin-6 serum concentration'}, {'measure': 'Anti-GM1 antibodies', 'timeFrame': '1, 2, 3, and 5 weeks', 'description': 'Anti-GM1 antibody serum levels'}, {'measure': 'Anti-GQ1b', 'timeFrame': '1, 2, 3, and 5 weeks', 'description': 'Anti-GQQ1b antibody serum levels'}, {'measure': 'Neurofilament light chain (NfL) serum', 'timeFrame': '1, 2, 3, and 5 weeks', 'description': 'Neurofilament light chain (NfL) serum levels'}, {'measure': 'Neurofilament light chain (NfL) in cerebrospinal fluid (CSF)', 'timeFrame': '2 weeks', 'description': 'Neurofilament light chain (NfL) levels in cerebrospinal fluid (CSF)'}, {'measure': 'Safety and Tolerability', 'timeFrame': '1, 2, 3, and 5 weeks', 'description': 'Kind and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)'}, {'measure': 'Therapeutic Response', 'timeFrame': '1, 2, 3, and 5 weeks', 'description': 'Share of patients with at least 20% improvement in CIDP score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['GBS']}, 'descriptionModule': {'briefSummary': 'This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of patients diagnosed with Guillain-Barré syndrome (GBS) who are treated with either plasma exchange or immunoadsorption in the Department of Neurology, University of Ulm.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Guillain-Barré Syndrome according to the diagnostic criteria proposed by Doorn et al. (Clinical features, pathogenesis, and treatment of Guillain-Barré syndrome, Lancet neurology 2008)\n* age 18 years or above\n\nExclusion Criteria:\n\n* Clinical or laboratory (C-reactive protein 20 mg/l or above, or evidence of nitrite-positive urinary tract infection) evidence of manifest systemic infection\n* Intake of angiotensin converting enzyme inhibitor within1 weeks before first treatment\n* Other contraindications against immunoadsorption or plasma exchange'}, 'identificationModule': {'nctId': 'NCT04871035', 'acronym': 'IPET-GBS', 'briefTitle': 'Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)', 'orgStudyIdInfo': {'id': 'IPET-GBS 1.2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Immunoadsorption', 'interventionNames': ['Device: Immunoadsorption']}, {'label': 'Plasma Exchange', 'interventionNames': ['Device: Plasma Exchange']}], 'interventions': [{'name': 'Immunoadsorption', 'type': 'DEVICE', 'description': '1 cycle, consisting of 5 sessions on 5 consecutive days with processing of the 0.7-fold individual plasma volume (maximum 2.5 l) each days with tryptophan adsorbers.', 'armGroupLabels': ['Immunoadsorption']}, {'name': 'Plasma Exchange', 'type': 'DEVICE', 'description': '1 cycle, consisting of 5 sessions on 5 consecutive days with exchange of 0.7-fold plasma volume (maximum 2.5 l) each day with albumin solution as volume replacement solution.', 'armGroupLabels': ['Plasma Exchange']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Albert C Ludolph, MD, Prof.', 'role': 'CONTACT', 'email': 'albert.ludolph@rku.de', 'phone': '+49-731-177-', 'phoneExt': '1200'}, {'name': 'Albert C Ludolph, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Neurology, University of Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'centralContacts': [{'name': 'Johannes Dorst, Prof', 'role': 'CONTACT', 'email': 'johannes.dorst@uni-ulm.de', 'phone': '+49 731 177 5285'}], 'overallOfficials': [{'name': 'Johannes Dorst, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ulm'}]}, 'ipdSharingStatementModule': {'url': 'https://www.uniklinik-ulm.de/neurologie.html', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '3 months after publication until 5 years after publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figures), as well as the study protocol will be available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at https://www.uniklinik-ulm.de/neurologie.html.', 'accessCriteria': 'Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'collaborators': [{'name': 'DiaMed GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Albert Christian Ludolph, Prof.', 'investigatorAffiliation': 'University of Ulm'}}}}