Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-05 @ 9:36 PM
Study NCT ID:
NCT02044692
Status:
UNKNOWN
Last Update Posted:
2014-06-20
First Post:
2014-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016532', 'term': 'Mucopolysaccharidosis II'}], 'ancestors': [{'id': 'D038901', 'term': 'X-Linked Intellectual Disability'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D009083', 'term': 'Mucopolysaccharidoses'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D017520', 'term': 'Mucinoses'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-19', 'studyFirstSubmitDate': '2014-01-19', 'studyFirstSubmitQcDate': '2014-01-22', 'lastUpdatePostDateStruct': {'date': '2014-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percent change of urine GAG.', 'timeFrame': 'Baseline and every three months up to 5years.'}, {'measure': 'Percent change of 6 minute walking test.', 'timeFrame': 'Baseline and every 6 months up to 5years.'}], 'primaryOutcomes': [{'measure': 'Incidence of adverse event and adverse drug reaction.', 'timeFrame': 'Once a week up to 5years'}], 'secondaryOutcomes': [{'measure': 'Change of vital sign, physical and clinical examination, anti-idurasulfase-beta antibody status.', 'timeFrame': 'Base line and every three months up to 5years.(exception: clinical examination-> baseline and every six months up to 5years)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hunter syndrome', 'Mucopolysaccharidosis II', 'Hunterase'], 'conditions': ['Hunter Syndrome']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the long term safety and efficacy of once weekly dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis II) Patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hunter Syndrome(Mucopolysaccharidosis II) Patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who have a diagnosis of Hunter syndrome(Mucopolysaccharidosis II).\n* Patients who are administered idurasulfase-beta or willing to be administered idurasulfase-beta.\n* Patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients who have participated in any other blind clinical trials.\n* Patient who cannot be tracked about safety.\n* Patients who are judged disqualified to participate clinical trials by investigator for other causes."}, 'identificationModule': {'nctId': 'NCT02044692', 'briefTitle': 'The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'GC Biopharma Corp'}, 'officialTitle': 'The Long-term Safety of Hunterase (Idursulfase-beta) in Hunter Syndrome(Mucopolysaccharidosis II) Patients', 'orgStudyIdInfo': {'id': 'GC1111_OS'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dongkyu Jin', 'role': 'CONTACT'}, {'name': 'Dong Kyu Jin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Dong-Kyu Jin', 'role': 'CONTACT', 'email': 'jindk.jin@samsung.com'}], 'overallOfficials': [{'name': 'Dong-Kyu Jin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung medical center, Seoul, Republic of Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Green Cross Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}