Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-01-26 @ 6:37 PM
Study NCT ID:
NCT01766518
Status:
UNKNOWN
Last Update Posted:
2013-11-07
First Post:
2013-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study to Evaluate Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients (MYLT1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-06', 'studyFirstSubmitDate': '2013-01-10', 'studyFirstSubmitQcDate': '2013-01-10', 'lastUpdatePostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of adverse event', 'timeFrame': 'up to 26 weeks'}, {'measure': 'Laboratory test', 'timeFrame': 'up to 26weeks'}, {'measure': 'Physical exam, pulse rate et.', 'timeFrame': 'up to 26weeks'}], 'primaryOutcomes': [{'measure': 'Rate of acute rejection', 'timeFrame': 'up to 26weeks', 'description': 'Rate acute rejection by liver biopsy'}], 'secondaryOutcomes': [{'measure': 'Frequency, Time, Severity of acute rejection', 'timeFrame': 'up to 26 weeks'}, {'measure': 'Graft loss, Patient survival rate', 'timeFrame': 'up to 26weeks'}, {'measure': 'Kidney function test by e-GFR(Glomerular filtration rate)', 'timeFrame': 'up to 26weeks'}, {'measure': 'Questionnaire of gastrointestinal symptom assessment', 'timeFrame': 'screening visit, closing visit'}, {'measure': 'Questionnaire of gastrointestinal quality of life index', 'timeFrame': 'screening visit, closing visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['liver transplantation', 'LT', 'Mycophenolate mofetil', 'MMF'], 'conditions': ['Evidence of Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients', 'detailedDescription': 'Open label, Multicenter, Non-comparative Study to evaluate the efficacy and safety of MY-REPT capsule in primary, liver transplantation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with primary liver transplantation recipients\n* Male and Female aged ≥19 and ≤65\n* Patient with ABO blood type correspond with Donor's blood type\n* Patient who agreement with written informed consent\n* Patient who Women if had childbearing potential must have a negative serum or urine pregnancy test at the screening visit and agreement with contraception\n\nExclusion Criteria:\n\n* Patient with secondary liver transplantation(LT) recipient or other organ transplantation recipient in past or current\n* Patient with multi-organ transplantation recipient\n* Patient with dual-graft transplantation recipient\n* Patient who used body artificial liver before LT\n* Cr level \\>2.0mg/dL in screening\n* WBC \\<2,000/mm3 or ANC \\<900/mm3 or PLT \\<30,000/mm3 in screening\n* Patient who experienced severe gastrointestinal disorder so investigator judge the man's participation impossible\n* Patient who experienced severe infection (need to treatment)\n* Patient or Donor with HIV positive\n* Patient who need to treat with immunosuppressant or chemistry therapy\n* Patient who had taken immunosuppressant within 30days before LT (except to take Corticosteroids and Tacrolimus due to protocol)"}, 'identificationModule': {'nctId': 'NCT01766518', 'briefTitle': 'The Study to Evaluate Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients (MYLT1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Open Label, Multicenter, Non-comparative Study to Evaluate the Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients.', 'orgStudyIdInfo': {'id': 'm307LTP09D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MY-REPT capsule', 'description': 'MY-REPT capsule: Mycophenolate mofetil, 250mg/cap, orally', 'interventionNames': ['Drug: Mycophenolate mofetil']}], 'interventions': [{'name': 'Mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['MY-REPT capsule'], 'description': 'MY-REPT capsule 500\\~1500mg/day, per oral, capsules twice a day with Tacrolimus, Corticosteroids, Basiliximab post liver transplantation', 'armGroupLabels': ['MY-REPT capsule']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'SungGyu Lee, Ph.D', 'role': 'CONTACT', 'email': 'sglee2@amc.ac.kr', 'phone': '+82 2 3010 7182'}, {'name': 'SungGyu Lee, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asan medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': "Seoul ST Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'SungGyu Lee, Ph.D', 'role': 'CONTACT', 'email': 'sglee2@amc.seoul.kr', 'phone': '+82 2 3010 7182'}], 'overallOfficials': [{'name': 'SungGyu Lee, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}