Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-04-24 @ 8:13 PM
Study NCT ID:
NCT02097966
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2016-01-27
First Post:
2014-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EU: A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549273', 'term': 'daclatasvir'}, {'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2014-03-25', 'studyFirstSubmitQcDate': '2014-03-25', 'lastUpdatePostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '27845298', 'type': 'DERIVED', 'citation': 'Rockstroh JK, Ingiliz P, Petersen J, Peck-Radosavljevic M, Welzel TM, Van der Valk M, Zhao Y, Jimenez-Exposito MJ, Zeuzem S. Daclatasvir plus sofosbuvir, with or without ribavirin, in real-world patients with HIV-HCV coinfection and advanced liver disease. Antivir Ther. 2017;22(3):225-236. doi: 10.3851/IMP3108. Epub 2016 Nov 15.'}, {'pmid': '27605539', 'type': 'DERIVED', 'citation': 'Welzel TM, Petersen J, Herzer K, Ferenci P, Gschwantler M, Wedemeyer H, Berg T, Spengler U, Weiland O, van der Valk M, Rockstroh J, Peck-Radosavljevic M, Zhao Y, Jimenez-Exposito MJ, Zeuzem S. Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort. Gut. 2016 Nov;65(11):1861-1870. doi: 10.1136/gutjnl-2016-312444. Epub 2016 Sep 7.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/investigator_sponsored_research/Pages/expanded-access-program.aspx', 'label': 'EAP Investigator Requests'}, {'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this program is to provide Daclatasvir in combination with Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'This program is conducted in the EU (Germany, Austria, Norway, The Netherlands, Sweden and United Kingdom only)\n\nFor more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Patients chronically infected with Hepatitis C\n* Patients at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options\n\nExclusion Criteria:\n\n* Patients who are \\<18 years old\n* Patients who have contraindications to either Daclatasvir (DCV) or Sofosbuvir (SOF)\n* Patients who are pregnant\n* Creatinine clearance (CrCl) ≤ 30 mL/min (as estimated by Cockcroft and Gault formula)\n* Patients who are pregnant or Women of Child Bearing Potential who are not using required contraception'}, 'identificationModule': {'nctId': 'NCT02097966', 'briefTitle': 'EU: A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C', 'orgStudyIdInfo': {'id': 'AI444-237'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Daclatasvir', 'type': 'DRUG', 'otherNames': ['BMS-790052']}, {'name': 'Sofosbuvir', 'type': 'DRUG'}, {'name': 'Ribavirin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amstetten', 'country': 'Austria', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.1229, 'lon': 14.87206}}, {'city': 'Braunua/Inn', 'country': 'Austria', 'facility': 'Local Institution'}, {'city': 'Graz', 'country': 'Austria', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Linz', 'country': 'Austria', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Oberndorf', 'country': 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