Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-03-06 @ 6:07 PM
Study NCT ID:
NCT03205618
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2017-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective, Observational Study on the Effectiveness of Daclatasvir-Containing Regimens in Patients in KSA, UAE and Qatar
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-10', 'studyFirstSubmitDate': '2017-06-29', 'studyFirstSubmitQcDate': '2017-06-29', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants achieving sustained virological response 12 weeks post-treatment (SVR12)', 'timeFrame': '12 weeks after the last dose of study treatment', 'description': 'Patients will be considered to have achieved SVR12 if they have a documented undetectable viral load on or after Week 12 following the end of treatment.'}], 'secondaryOutcomes': [{'measure': 'Distribution of SVR12 by Treatment Regimen', 'timeFrame': '12 weeks after the last dose of study treatment', 'description': 'Defined as any daclatasvir containing regimen. Subgroups include: daclatasvir + sofosbuvir; daclatasvir + sofosbuvir + RBV; daclatasvir + simeprevir; daclatasvir + simeprevir + ribavirin.'}, {'measure': 'Distribution of SVR12 by Country', 'timeFrame': '12 weeks after the last dose of study treatment', 'description': 'Defined as the country where treatment with a daclatasvir containing regimen was initiated. Subgroups include Saudi Arabia, UAE, and Qatar.'}, {'measure': 'Distribution of SVR12 by Genotype', 'timeFrame': '12 weeks after the last dose of study treatment', 'description': 'Subgroups genotype 3 and genotype 4'}, {'measure': 'Distribution of SVR12 by HCV-Treatment Experience', 'timeFrame': '12 weeks after the last dose of study treatment', 'description': 'Subgroups include patients in which prior treatment with IFN and RBV has failed; prior treatment with IFN, RBV and telaprevir or boceprevir has failed; previous treatment with IFN, RBV and simeprevir has failed; previous treatment with sofosbuvir and RBV has failed.'}, {'measure': 'Distribution of SVR12 by HIV co-infection', 'timeFrame': '12 weeks after the last dose of study treatment', 'description': 'Subgroup defined as HIV diagnosis prior to the initiation of daclatasvir containing regimen.'}, {'measure': 'Distribution of SVR12 by previous liver transplantation', 'timeFrame': '12 weeks after the last dose of study treatment', 'description': 'Subgroup defined by patients undergoing a liver transplant for any cause prior to the initiation of a daclatasvir containing regimen'}, {'measure': 'Incidence of Serious Adverse Events (SAE)', 'timeFrame': 'Up to 12 months', 'description': 'Measured by number of patients reporting SAEs'}, {'measure': 'Incidence of Adverse Events leading to discontinuation', 'timeFrame': 'Up to 12 months', 'description': 'Measured by number of patients reporting AEs that result in treatment discontinuation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': 'The study will provide safety and efficacy information among patients receiving daclatasvir. It will describe daclatasvir prescribing patterns and provide a clinical profile of patients receiving the treatment in KSA, UAE, and Qatar.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll all patients initiating a new daclatasvir-containing HCV treatment, regardless of treatment history and previous treatment response from availability of the drug on country markets up to 01-Oct-2015.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients greater than or equal to 18 years of age\n* Diagnosed with chronic hepatitis C\n* Ended treatment with daclatasvir-containing regimen no later than 01-Oct-2015\n\nExclusion Criteria:\n\n* Use of a daclatasvir-containing regimen in a clinical trial setting\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03205618', 'briefTitle': 'A Retrospective, Observational Study on the Effectiveness of Daclatasvir-Containing Regimens in Patients in KSA, UAE and Qatar', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Effectiveness of Daclatasvir-Containing Regimens in Patients Treated in Real-Life Setting in Kingdom of Saudi Arabia (KSA), United Arab Emirates (UAE) and Qatar', 'orgStudyIdInfo': {'id': 'AI444-382'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'daclatasvir patients in KSA, UAE, and Qatar', 'description': 'patients treated with daclatasvir-containing regimens in KSA, UAE, and Qatar', 'interventionNames': ['Other: Non-Interventional']}], 'interventions': [{'name': 'Non-Interventional', 'type': 'OTHER', 'description': 'Non-Interventional', 'armGroupLabels': ['daclatasvir patients in KSA, UAE, and Qatar']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Doha', 'country': 'Saudi Arabia', 'facility': 'Local Institution'}, {'zip': '23325', 'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Local Institution', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'zip': '11211', 'city': 'Riyadh-11211', 'country': 'Saudi Arabia', 'facility': 'Local Institution'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}