Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-03-29 @ 4:08 AM
Study NCT ID:
NCT04097704
Status:
COMPLETED
Last Update Posted:
2020-05-21
First Post:
2019-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-20', 'studyFirstSubmitDate': '2019-09-19', 'studyFirstSubmitQcDate': '2019-09-19', 'lastUpdatePostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria', 'timeFrame': 'Day 1', 'description': 'DNA Quality'}], 'secondaryOutcomes': [{'measure': 'Adverse Events (AEs)', 'timeFrame': 'Time from ICF to Day 1', 'description': 'Number of participants with adverse event'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatic impairment', 'CC-90007-CP-003', 'Healthy Subject'], 'conditions': ['Hepatic Insufficiency']}, 'descriptionModule': {'briefSummary': 'This is a multi-center observational follow-up study to collect saliva samples that allow pharmacogenetic analysis of the subjects that participated in the CC-90007-CP-003 study.\n\nApproximately 28 subjects with moderate and severe hepatic impairment and healthy control subjects with normal hepatic function will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 28 subjects from the CC-90007-CP-003 study (from any race, males or non-pregnant and non-nursing females) will be enrolled. The study will be conducted at approximately 3 sites in the US that participated in the CC-90007-CP-003 study. Subjects may not be replaced with subjects that did not participate in the CC-90007-CP-003 study.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nEach subject must satisfy all of the following criteria to be enrolled in this study:\n\n1. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.\n2. Subject is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules and other protocol requirements.\n3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.\n4. Subject participated in the CC-90007-CP-003 study.\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude a subject from enrollment:\n\n1. Subject has any condition which places the subject at unacceptable risk if he/she were to participate in the study.\n2. Subject has any condition that confounds the ability to interpret data from the study.\n\nSponsor's medical monitor should be consulted on suspected conditions under this exclusion criterion, prior to exclusion."}, 'identificationModule': {'nctId': 'NCT04097704', 'briefTitle': 'Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'An Observational Follow-on Study to Describe the Pharmacogenetics of the CC-90007-CP-003 Study Cohort', 'orgStudyIdInfo': {'id': 'NDS-CP-003'}, 'secondaryIdInfos': [{'id': 'U1111-1237-0411', 'type': 'OTHER', 'domain': 'WHO'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014-3616', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology of Miami, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center OCRC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'Leon Carayannopoulos, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Celgene Corporation'}]}, 'ipdSharingStatementModule': {'url': 'https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'See Plan Description', 'ipdSharing': 'YES', 'description': 'Information relating to our policy on data sharing and the process for requesting data can be found at the following link:\n\nhttps://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/', 'accessCriteria': 'See Plan Description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}