Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-29 @ 8:59 PM
Study NCT ID:
NCT00515450
Status:
COMPLETED
Last Update Posted:
2010-07-30
First Post:
2007-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}, {'id': 'D010956', 'term': 'Plasmapheresis'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-29', 'studyFirstSubmitDate': '2007-08-10', 'studyFirstSubmitQcDate': '2007-08-10', 'lastUpdatePostDateStruct': {'date': '2010-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in QMG score', 'timeFrame': 'at 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels', 'timeFrame': 'from beginning of the treatment through 4th week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myasthenia Gravis'], 'conditions': ['Generalized Myasthenia Gravis']}, 'descriptionModule': {'briefSummary': 'This randomized controlled, multi-center study will carry out to assess the efficacy of GB-0998 compared to plasmapheresis in the treatment of the generalized Myasthenia Gravis based on the changes in Quantitative Myasthenia Gravis score (QMG score) as primary endpoint, and in addition, to assess the safety of GB-0998'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed as generalized myasthenia gravis\n* Patients who are not controlled by current therapy and need plasmapheresis therapy\n* Patients who have the high-dose steroid therapy for over a month in past years, and also who take steroid or immunosuppressant on the day of consent\n* Patients who had not any dose increase or new dosing of steroid or immunosuppressant within 4 weeks prior to enrollment\n\nExclusion Criteria:\n\n* Patients who received steroid pulse therapy, globulin therapy or plasmapheresis therapy within 12 weeks prior to enrollment\n* Patients who had undergone thymectomy within 24 weeks prior to enrollment\n* Patients with 3 points item in bulbar symptom of MG-ADL scale\n* Patients with severe hepatic disorder, severe renal disorder or severe heat disorder\n* Patients who have received treatment of malignant tumors\n* Patients who have the anamnesis of shock or hypersensitivity to this drug\n* Patients who have been diagnosed as hereditary fructose intolerance\n* Patients who have the anamnesis of cerebral infarction or symptom of these diseases\n* Patients who have been diagnosed as IgA deficiency in their past history\n* Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant\n* Patients who were administered other investigational drug within 12 weeks before consent'}, 'identificationModule': {'nctId': 'NCT00515450', 'briefTitle': 'Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Benesis Corporation'}, 'officialTitle': 'A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis', 'orgStudyIdInfo': {'id': '0998-B1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: GB-0998 (Intravenous immunoglobulin)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Procedure: Plasmapheresis']}], 'interventions': [{'name': 'GB-0998 (Intravenous immunoglobulin)', 'type': 'BIOLOGICAL', 'otherNames': ['Venoglobulin-IH'], 'armGroupLabels': ['1']}, {'name': 'Plasmapheresis', 'type': 'PROCEDURE', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '852-8501', 'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Nagasaki University', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}], 'overallOfficials': [{'name': 'Masaharu Takamori, Director', 'role': 'STUDY_CHAIR', 'affiliation': 'Neurological Center Kanazawa-Nishi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benesis Corporation', 'class': 'INDUSTRY'}}}}