Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2026-02-20 @ 8:25 PM
Study NCT ID:
NCT01410903
Status:
TERMINATED
Last Update Posted:
2015-08-19
First Post:
2011-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunoadsorption in Patients With Severe Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'inadequately recruitment rate, funding is not secured', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-18', 'studyFirstSubmitDate': '2011-08-04', 'studyFirstSubmitQcDate': '2011-08-04', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival under immunoadsorption', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'survival under immunoadsorption', 'timeFrame': '12 months'}, {'measure': 'Number of Serious Adverse Events', 'timeFrame': '12 months'}, {'measure': 'change in "modified Rodnan Skin Score"', 'timeFrame': '12 months'}, {'measure': 'change in Diffusing Capacity of the Lung for Carbon Monoxide', 'timeFrame': '12 months'}, {'measure': 'change in Scleroderma Health Assenssment Questionnaire', 'timeFrame': '12 months'}, {'measure': 'change of pulmonary arterial pressure', 'timeFrame': '12 months'}, {'measure': 'reoccurrence of finger ulcers', 'timeFrame': '12 months'}, {'measure': 'healing of finger ulcers', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Systemic Scleroderma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate source data for the survival and the investigation of the preliminary efficacy of immunoadsorption in patients with severe systemic sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systemic sclerosis according to the ACE-criteria\n* severe pulmonary manifestation with reduced DLCO\n* signed informed consent\n\nExclusion Criteria:\n\n* inadequate peripheral venous access\n* participation in another clinical trial\n* heart failure\n* pronounced allergic diathesis, particularly in case of known hypersensitivity to drugs and/or materials used in the extracorporeal circuit'}, 'identificationModule': {'nctId': 'NCT01410903', 'briefTitle': 'Immunoadsorption in Patients With Severe Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'GWT-TUD GmbH'}, 'officialTitle': 'Immunoadsorption in Addition to the Established Therapy in Patients With Systemic Sclerosis', 'orgStudyIdInfo': {'id': 'IAS - SSc 2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TheraSorb Ig', 'interventionNames': ['Device: TheraSorb Ig']}], 'interventions': [{'name': 'TheraSorb Ig', 'type': 'DEVICE', 'otherNames': ['Ig-TheraSorb', 'code 330-000-452'], 'description': '1,5 plasma volume per treatment venovenous immunoadsorption frequency: three times weekly in week 1 and 2, two times weekly in week 3-6, two times two-weekly in week 7-12 duration: 12 months', 'armGroupLabels': ['TheraSorb Ig']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Martin Aringer, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Dresden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GWT-TUD GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Miltenyi Biomedicine GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}