Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT01573351
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2012-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, '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': 'C571889', 'term': 'asunaprevir'}, {'id': 'C549273', 'term': 'daclatasvir'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-09-23', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2012-04-05', 'dispFirstSubmitQcDate': '2015-09-23', 'studyFirstSubmitQcDate': '2012-04-06', 'dispFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of genotype 1 subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for all subjects infected with HCV genotype 1', 'timeFrame': 'At 12 weeks post-treatment'}], 'secondaryOutcomes': [{'measure': 'On-treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) through the end of treatment', 'timeFrame': 'Through the end of treatment (maximum up to 24 weeks) plus 7 days'}, {'measure': 'Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 gene', 'timeFrame': 'At post-treatment Week 12'}, {'measure': 'Proportion of subjects with HCV RNA undetectable', 'timeFrame': 'Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [Extended rapid virologic response (eRVR)], end of treatment (up to 24 weeks), post-treatment Week 12 or post-treatment Week 24'}, {'measure': 'Proportion of subjects with HCV RNA < LOQ', 'timeFrame': 'Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12, end of treatment (up to 24 weeks), post-treatment Week 24 (SVR24)'}, {'measure': 'Proportion of patients with SVR12 (HCV RNA < LOQ at post-treatment Week 12) for HCV genotype 4 subjects', 'timeFrame': 'Post-treatment Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus']}, 'referencesModule': {'references': [{'pmid': '25703086', 'type': 'DERIVED', 'citation': 'Jensen D, Sherman KE, Hezode C, Pol S, Zeuzem S, de Ledinghen V, Tran A, Elkhashab M, Younes ZH, Kugelmas M, Mauss S, Everson G, Luketic V, Vierling J, Serfaty L, Brunetto M, Heo J, Bernstein D, McPhee F, Hennicken D, Mendez P, Hughes E, Noviello S; HALLMARK-QUAD Study Team. Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders. J Hepatol. 2015 Jul;63(1):30-7. doi: 10.1016/j.jhep.2015.02.018. Epub 2015 Feb 19.'}], '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 efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \\< Limit of quantitation (LOQ) at post-treatment Week 12.', 'detailedDescription': '* ASV = Asunaprevir (BMS-650032)\n* DCV = Daclatasvir (BMS-790052)\n* Peg = Peg-interferon Alfa-2a (PegIFN)\n* Rib = Ribavirin (RBV)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females, ≥ 18 years of age\n* HCV Genotype 1 or 4 who previously failed treatment with Peginterferon alfa-2a or peginterferon alfa-2b and Ribavirin (P/R), classified as previous null and partial responders based on previous therapy\n* HCV RNA ≥ 10,000 IU/mL\n* Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)\n* Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)\n\nExclusion Criteria:\n\n* Prior treatment of HCV with HCV direct acting antiviral (DAA)\n* Evidence of a medical condition contributing to chronic liver disease other than HCV\n* Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy\n* Diagnosed or suspected hepatocellular carcinoma or other malignancies\n* Uncontrolled diabetes or hypertension\n* Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease\n* Alanine aminotransferase (ALT) ≥ 5x Upper limit of normal (ULN)\n* Albumin \\< 3.5 g/dL (35 g/L)\n* Alpha Fetoprotein (AFP) \\> 100 ng/mL (\\>82.6 IU/mL) or ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of Hepatocellular carcinoma (HCC) are excluded\n* Absolute neutrophil count (ANC) \\< 1.5 x 1000,000,000 cells/L (\\< 1.2 x 1000,000,000 cells/L for Black/African-Americans)\n* Platelets \\< 90 x 1000,000,000 cells/L\n* Hemoglobin \\< 12 g/dL for females or \\< 13 g/dL for males\n* Any criteria that would exclude the subject from receiving P/R"}, 'identificationModule': {'nctId': 'NCT01573351', 'acronym': 'Hallmark QUAD', 'briefTitle': 'Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C Genotypes 1 or 4 Infection', 'orgStudyIdInfo': {'id': 'AI447-029'}, 'secondaryIdInfos': [{'id': '2011-005422-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin', 'description': 'Asunaprevir: Capsule, Oral, 100 mg, Twice daily, 24 weeks\n\nDaclatasvir: Tablet, Oral, 60 mg, Once daily, 24 weeks\n\nPeg-interferon Alfa-2a: Injection, subcutaneous (SC), 180 mcg/0.5 mL, Once weekly, 24 weeks\n\nRibavirin: Tablet, Oral, 1000 mg/1200 mg (total daily dose), 24 weeks', 'interventionNames': ['Drug: Asunaprevir', 'Drug: Daclatasvir', 'Drug: Peg-interferon Alfa-2a', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Asunaprevir', 'type': 'DRUG', 'otherNames': ['BMS-650032'], 'armGroupLabels': ['QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin']}, {'name': 'Daclatasvir', 'type': 'DRUG', 'otherNames': ['BMS-790052'], 'armGroupLabels': ['QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin']}, {'name': 'Peg-interferon Alfa-2a', 'type': 'DRUG', 'otherNames': ['Pegasys®'], 'armGroupLabels': ['QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Copegus®'], 'armGroupLabels': ['QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36116', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Liver & Digestive Specialists (Alds)', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Scpmg/ Kaiser Permanente Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University Of Colorado Denver And Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'South Denver Gastroenterology, Pc', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University Of Miami Schiff Center For Liver Diseases', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60637-1432', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University Of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': 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