Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-01 @ 8:38 PM
Study NCT ID:
NCT01224457
Status:
COMPLETED
Last Update Posted:
2012-01-31
First Post:
2010-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010634', 'term': 'Phenobarbital'}], 'ancestors': [{'id': 'D001463', 'term': 'Barbiturates'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-26', 'studyFirstSubmitDate': '2010-10-19', 'studyFirstSubmitQcDate': '2010-10-19', 'lastUpdatePostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pb drug concentration', 'timeFrame': '48 hours after administering phenobarbital', 'description': 'pb drug concentration, CYP2C9/CYP2C19 polymorphism'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neonatal Seizure']}, 'descriptionModule': {'briefSummary': 'The pharmacogenomic profiles of drug metabolizing enzymes play an important role in pharmacokinetics (PK) of drugs. Phenobarbital (PB), worldwidely used for neonatal seizure, is a drug that requires careful dose adjustments based on therapeutic drug monitoring. It was reported that phenobarbital (PB) metabolism was affected by CYP2C9 and CYP2C19 polymorphisms in adults. This study aims to evaluate the effects of the CYP2C9 and CYP2C19 genetic polymorphisms on PB PK in infants with neonatal seizure for an optimal dosing strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infant treated by phenobarbital monotherapy, diagnosed neonatal seizure\n* Infant taken the drug concentration one more time\n* given the informed consent\n\nExclusion Criteria:\n\n* progressed CNS disorder\n* severe systemic illness\n* GOT/GPT level more than 2times of normal value,more than 3times elevation of BUN/creatinine level\n* congenital hemolytic anemia\n* genetic disorder'}, 'identificationModule': {'nctId': 'NCT01224457', 'briefTitle': 'Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.', 'orgStudyIdInfo': {'id': '4-2008-0029'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Phenobarbital', 'type': 'DRUG', 'description': 'phenobarbital 20mg/kg iv infusion, after 24hours of loading, 2.5mg/kg bid daily'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}