Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-03 @ 8:25 PM
Study NCT ID:
NCT06625957
Status:
RECRUITING
Last Update Posted:
2025-01-07
First Post:
2024-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 in Patients Who Require Parenteral Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-07-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-05', 'studyFirstSubmitDate': '2024-10-02', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurance rate of adverse drug reaction', 'timeFrame': 'Day 1 to day 4'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parenteral Nutrition']}, 'descriptionModule': {'briefSummary': 'A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 versus NTCB-C in patients who require parenteral nutrition'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those who are 19 years old or older at the screening visit\n* Patients are expected to require PN for more than 3 days\n* Patients who voluntarily signed the consent form\n\nExclusion Criteria:\n\n* Patients are expected difficult to survive more than 3 days\n* Patients BMI is over 30 kg/m2\n* Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug\n* Patients with difficult central venous line\n* Patients judged to be unsuitable for this trial by investigators'}, 'identificationModule': {'nctId': 'NCT06625957', 'briefTitle': 'Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 in Patients Who Require Parenteral Nutrition', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 Versus NTCB-C in Patients Who Require Parenteral Nutrition', 'orgStudyIdInfo': {'id': 'NTCB02-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NTCB02-1', 'interventionNames': ['Drug: NTCB02-1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NTCB-C', 'interventionNames': ['Drug: NTCB-C']}], 'interventions': [{'name': 'NTCB02-1', 'type': 'DRUG', 'description': '3 Days infusion', 'armGroupLabels': ['NTCB02-1']}, {'name': 'NTCB-C', 'type': 'DRUG', 'description': '3 Days infusion', 'armGroupLabels': ['NTCB-C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10408', 'city': 'Gyeonggi-do', 'state': 'Goyang-si', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '58128', 'city': 'Jeollanam-do', 'state': 'Hwasun-gun', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Chonnam National University Hwasun Hospital'}, {'zip': '54907', 'city': 'Jeollabuk-do', 'state': 'Jeonju-si', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Jeonbuk National University Hospital'}, {'zip': '03722', 'city': 'Seoul', 'state': 'Seodaemun-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '13620', 'city': 'Gyeonggi-do', 'state': 'Seongnam-si', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Bundang', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}], 'centralContacts': [{'name': 'Jinhyun Choi', 'role': 'CONTACT', 'email': 'clinicaltrials@yuhan.co.kr', 'phone': '8228280850'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}