Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-01 @ 2:04 PM
Study NCT ID:
NCT02551861
Status:
WITHDRAWN
Last Update Posted:
2016-01-15
First Post:
2015-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3
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': '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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-14', 'studyFirstSubmitDate': '2015-09-15', 'studyFirstSubmitQcDate': '2015-09-15', 'lastUpdatePostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF)', 'timeFrame': 'Post Treatment Follow up Week 12', 'description': 'SVR12 defined as HCV RNA \\< LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects treated with 8 weeks of DCV+SOF therapy or DCV+SOF+RBV therapy'}], 'secondaryOutcomes': [{'measure': 'Safety measured by number of incidence of deaths, serious adverse events (SAE)s, discontinuation due to adverse events (AE)s, Grade 3/4 AEs and Grade 3/4 laboratory abnormalities observed from clinical laboratory testing', 'timeFrame': 'Approximately 1.5 years'}, {'measure': 'Antiviral activity measured by the proportion of subjects who achieve HCV RNA < lower limit of quantification (LLOQ) - at during and after treatment in each treatment arm', 'timeFrame': 'Post treatment follow up Week 24'}, {'measure': 'Proportion of subjects with CC, CT or TT IL28B genotype who achieve SVR12 in each treatment arm', 'timeFrame': 'Post Treatment Follow up Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'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 determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Genotype 3\n* HCV RNA \\< 2000000 IU/mL\n* Never taken HCV medication\n* Absence of advanced fibrosis or cirrhosis\n* Body mass index (BMI) 18-40 kg/m\\^2\n\nExclusion Criteria:\n\n* Infection with HCV other than genotype 3 (GT3); Mixed infections of any genotype\n* Previously taken HCV medication\n* Liver Cirrhosis\n* Evidence of decompensated liver disease\n* HIV/ hepatitis B virus (HBV) coinfection'}, 'identificationModule': {'nctId': 'NCT02551861', 'briefTitle': 'A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-Cirrhotic Subjects Infected With Chronic HCV Genotype 3', 'orgStudyIdInfo': {'id': 'AI444-377'}, 'secondaryIdInfos': [{'id': '2015-003468-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Daclatasvir + Sofosbuvir', 'description': 'Daclatasvir 60mg tablet and Sofosbuvir 400mg tablet oral dosing once daily for 8 weeks', 'interventionNames': ['Drug: Daclatasvir', 'Drug: Sofosbuvir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Daclatasvir + Sofosbuvir + Ribavirin', 'description': 'Daclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm once daily for 8 weeks', 'interventionNames': ['Drug: Daclatasvir', 'Drug: Sofosbuvir', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Daclatasvir', 'type': 'DRUG', 'armGroupLabels': ['Daclatasvir + Sofosbuvir', 'Daclatasvir + Sofosbuvir + Ribavirin']}, {'name': 'Sofosbuvir', 'type': 'DRUG', 'armGroupLabels': ['Daclatasvir + Sofosbuvir', 'Daclatasvir + Sofosbuvir + Ribavirin']}, {'name': 'Ribavirin', 'type': 'DRUG', 'armGroupLabels': ['Daclatasvir + Sofosbuvir + Ribavirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2S2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5Z 1H2', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6Z 2K5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8V 3P9', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}