Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-02-02 @ 6:15 PM
Study NCT ID:
NCT00189761
Status:
COMPLETED
Last Update Posted:
2006-09-20
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'lastUpdateSubmitDate': '2006-09-19', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2006-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Tacrolimus', 'Immunosuppression', 'Bone Marrow Transplantation', 'Graft versus Host Disease'], 'conditions': ['Bone Marrow Transplantation', 'Graft Versus Host Disease', 'Graft-Vs-Host Disease', 'Graft-Versus-Host Disease']}, 'descriptionModule': {'briefSummary': 'A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '54 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bone marrow transplantation patients aged 20-54 except for transplanted from genetically HLA matched sibling donor.\n* The patient had been fully informed.\n\nExclusion Criteria:\n\n* The patient had severe impaired hepatic function.\n* The patient had impaired renal function.\n* The patient had existing complication of severe cardiac dysfunction.\n* The patient had severe impaired pulmonary function.'}, 'identificationModule': {'nctId': 'NCT00189761', 'briefTitle': 'A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 2, Open-Label, Multi-Center Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in De Novo Bone Marrow Transplant Recipients', 'orgStudyIdInfo': {'id': 'FJ-506E-BT01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tacrolimus', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chubu Region', 'country': 'Japan'}, {'city': 'Hokkaido Region', 'country': 'Japan'}, {'city': 'Kanto Region', 'country': 'Japan'}, {'city': 'Kyusyu Region', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Clinical development', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc., Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}}}}