Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-02 @ 4:08 AM
Study NCT ID:
NCT03071133
Status:
COMPLETED
Last Update Posted:
2022-02-23
First Post:
2017-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 344}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2017-03-01', 'studyFirstSubmitQcDate': '2017-03-03', 'lastUpdatePostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Aspartate Aminotransferase (AST) elevation', 'timeFrame': 'Up to 36 weeks', 'description': 'measured by immunoassay'}, {'measure': 'Incidence of Alanine Aminotransferase (ALT) elevation', 'timeFrame': 'Up to 36 weeks', 'description': 'measured by immunoassay'}, {'measure': 'Incidence of Total Bilirubin (tBili) elevation', 'timeFrame': 'Up to 36 weeks', 'description': 'measured by immunoassay'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan', 'timeFrame': 'Up to 36 weeks', 'description': 'measured by adverse events'}, {'measure': 'Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)', 'timeFrame': 'Up to 24 weeks', 'description': 'measured by number of patients'}, {'measure': 'Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24)', 'timeFrame': 'Up to 36 weeks', 'description': 'measured by number of patients'}, {'measure': 'Percentage of patients to experience virologic breakthrough', 'timeFrame': 'Up to 36 weeks', 'description': 'measured by percentage of patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in Japan who are initiating treatment with DCV Trio therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are initiating the treatment with DCV Trio therapy under the approved indications, dosage, and administration\n\nExclusion Criteria:\n\n* Patients who use the DCV Trio off label'}, 'identificationModule': {'nctId': 'NCT03071133', 'briefTitle': 'Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Asunaprevir/Daclatasvir/Beclabuvir Fixed-Dose Combination Safety Surveillance in Japanese Patients With Chronic Hepatitis C (HCV) or Japanese Patients With Compensated Cirrhosis', 'orgStudyIdInfo': {'id': 'AI443-144'}}, 'contactsLocationsModule': {'locations': [{'zip': '1620814', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}