Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT01497834
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2011-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549273', 'term': 'daclatasvir'}, {'id': 'C571889', 'term': 'asunaprevir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-09-23', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2011-12-02', 'dispFirstSubmitQcDate': '2015-09-23', 'studyFirstSubmitQcDate': '2011-12-20', 'dispFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antiviral activity, as determined by the proportion of subjects with SVR24', 'timeFrame': 'After 24 weeks of the last dose', 'description': 'SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)'}], 'secondaryOutcomes': [{'measure': 'Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below lower limit of quantitation (LLOQ) target detected or not detected', 'timeFrame': 'Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12'}, {'measure': 'Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected', 'timeFrame': 'Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24'}, {'measure': 'Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), AEs by intensity and laboratory abnormalities by toxicity grade', 'timeFrame': 'End of treatment plus 7 days'}, {'measure': 'Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)]', 'timeFrame': 'Follow-up Week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis C Virus Infection'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '27287851', 'type': 'DERIVED', 'citation': 'Hernandez D, Yu F, Huang X, Kirov S, Pant S, McPhee F. Impact of Pre-existing NS5A-L31 or -Y93H Minor Variants on Response Rates in Patients Infected with HCV Genotype-1b Treated with Daclatasvir/Asunaprevir. Adv Ther. 2016 Jul;33(7):1169-79. doi: 10.1007/s12325-016-0354-1. Epub 2016 Jun 10.'}, {'pmid': '26683763', 'type': 'DERIVED', 'citation': 'Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.'}, {'pmid': '24604476', 'type': 'DERIVED', 'citation': 'Kumada H, Suzuki Y, Ikeda K, Toyota J, Karino Y, Chayama K, Kawakami Y, Ido A, Yamamoto K, Takaguchi K, Izumi N, Koike K, Takehara T, Kawada N, Sata M, Miyagoshi H, Eley T, McPhee F, Damokosh A, Ishikawa H, Hughes E. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology. 2014 Jun;59(6):2083-91. doi: 10.1002/hep.27113. Epub 2014 Apr 1.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic HCV-1b infected patient\n* HCV RNA viral load of ≥ 100,000 IU/mL at screening\n* Ages 20 to 75 years\n* Non-responder to Interferon plus Ribavirin therapy\n* Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy\n\nExclusion Criteria:\n\nPatients who have -\n\n* Hepatocellular carcinoma\n* Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)\n* Severe or uncontrollable complication'}, 'identificationModule': {'nctId': 'NCT01497834', 'briefTitle': 'A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 3 Japanese Study of BMS-790052 Plus BMS-650032 Combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects Who Are Non Response to Interferon Plus Ribavirin and Interferon Based Therapy Ineligible Naive/Intolerant', 'orgStudyIdInfo': {'id': 'AI447-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daclatasvir + Asunaprevir', 'interventionNames': ['Drug: BMS-790052 (Daclatasvir)', 'Drug: BMS-650032 (Asunaprevir)']}], 'interventions': [{'name': 'BMS-790052 (Daclatasvir)', 'type': 'DRUG', 'description': 'Tablets, Oral, 60mg, Once daily, 24 weeks', 'armGroupLabels': ['Daclatasvir + Asunaprevir']}, {'name': 'BMS-650032 (Asunaprevir)', 'type': 'DRUG', 'description': 'Capsules, Oral, 100mg, Twice daily, 24 weeks', 'armGroupLabels': ['Daclatasvir + Asunaprevir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4668560', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '2608677', 'city': 'Chiba', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '8108563', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '8300011', 'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'zip': '5038502', 'city': 'Ogaki-shi', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '7340037', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '0600033', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '6608511', 'city': 'Amagasaki-shi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '9208641', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '7608557', 'city': 'Takamatsu', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'zip': '8908520', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '2138587', 'city': 'Kawasaki-Shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '9808574', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '7008558', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '5458586', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '5898511', 'city': 'Osaka-sayama-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '5640013', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '5650871', 'city': 'Suita-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '350-0495', 'city': 'Iruma-Gun', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '1138655', 'city': 'Bunkyo-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '1058470', 'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '1808610', 'city': 'Musashino-shi', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '1428666', 'city': 'Shinagawa-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '4093898', 'city': 'Chuo-shi', 'state': 'Yamanashi', 'country': 'Japan', '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'}}}}