Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-03 @ 12:08 PM
Study NCT ID:
NCT00212368
Status:
COMPLETED
Last Update Posted:
2010-09-10
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Zinc Acetate to Treat Wilson's Disease in Japan.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019345', 'term': 'Zinc Acetate'}], 'ancestors': [{'id': 'D019342', 'term': 'Acetic Acid'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-09', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ["Wison's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Wilson's disease(adult,infant,pregnant woman)\n\nExclusion Criteria:\n\n* acute hepatitis\n* malignant tumor"}, 'identificationModule': {'nctId': 'NCT00212368', 'briefTitle': "Efficacy and Safety Study of Zinc Acetate to Treat Wilson's Disease in Japan.", 'organization': {'class': 'INDUSTRY', 'fullName': 'Nobelpharma'}, 'officialTitle': "Phase3,Open-label,Clinical Trial of Zinc Acetate for Treatment of Wilson's Disease in Japan.", 'orgStudyIdInfo': {'id': 'NPC-02-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Zinc acetate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Koudou Ishii, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National MINAMIYOKOHAMA Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nobelpharma', 'class': 'INDUSTRY'}}}}