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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002468-20 | EudraCT Number |
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To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A 1: DCV/ASV/BMS-791325 in treatment-naive subjects | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks |
|
| A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects | Experimental | Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCV/ASV/BMS-791325 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12 | SVR12 is defined as HCV ribonucleic acid (RNA) < limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12 | Post-Treatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects in the experienced cohort with SVR12 | Follow up Week 12 | |
| Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND | On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24) |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic | La Jolla | California | 92037 | United States | ||
| Medical Associates Research Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25942723 | Derived | Poordad F, Sievert W, Mollison L, Bennett M, Tse E, Brau N, Levin J, Sepe T, Lee SS, Angus P, Conway B, Pol S, Boyer N, Bronowicki JP, Jacobson I, Muir AJ, Reddy KR, Tam E, Ortiz-Lasanta G, de Ledinghen V, Sulkowski M, Boparai N, McPhee F, Hughes E, Swenson ES, Yin PD; UNITY-1 Study Group. Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection. JAMA. 2015 May 5;313(17):1728-35. doi: 10.1001/jama.2015.3860. |
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| Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND | On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24 |
| Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort | Up to post treatment week 4 (±7 days) |
| Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort | Up to post treatment week 4 (±7 days) |
| Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort | Up to post treatment week 4 (±7 days) |
| Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b | Post treatment week 12 |
| Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype) | Post treatment week 12 |
| Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis | Post treatment week 12 |
| San Diego |
| California |
| 92123 |
| United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| University Of Colorado Denver & Hospital | Aurora | Colorado | 80045 | United States |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Gastrointestinal Specialists Of Georgia | Marietta | Georgia | 30060 | United States |
| University Of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Indiana University Med Center | Indianapolis | Indiana | 46202 | United States |
| Digestive Disease Associates, P.A. | Catonsville | Maryland | 21228 | United States |
| Johns Hopkins Medical Institutions | Lutherville | Maryland | 21093 | United States |
| Henry Ford Health System | Novi | Michigan | 48377 | United States |
| Kansas City Care Clinic | Kansas City | Missouri | 64111 | United States |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | United States |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | United States |
| The Gastroenterology Group Of South Jersey | Vineland | New Jersey | 08360 | United States |
| Binghamton Gastroenterology Associates | Binghamton | New York | 13903 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Premier Medical Group Of The Hudson Valley, Pc | Poughkeepsie | New York | 12601 | United States |
| James J Peters Vamc | The Bronx | New York | 10468 | United States |
| Asheville Gastroenterology Associates, Pa | Asheville | North Carolina | 28801 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Carolinas Center For Liver Disease | Statesville | North Carolina | 28677 | United States |
| Trial Management Associates, Llc | Wilmington | North Carolina | 28403 | United States |
| Digestive Health Specialists, Pa | Winston-Salem | North Carolina | 27103 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Options Health Research, Llc | Tulsa | Oklahoma | 74104 | United States |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18102 | United States |
| Hospital Of The University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University Of Pittsburgh Medical Center, Ctr For Liver Diseases | Pittsburgh | Pennsylvania | 15213 | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| Quality Medical Research Pllc | Nashville | Tennessee | 37211 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| Baylor St. Luke'S Medical Center | Houston | Texas | 77030 | United States |
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Mt Vernon Endoscopy Center | Alexandria | Virginia | 22306 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Bon Secours St. Mary'S Hospital Of Richmond, Inc. | Newport News | Virginia | 23602 | United States |
| Digestive And Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| Dean Clinic | Madison | Wisconsin | 53715 | United States |
| Local Institution | Darlinghurst | New South Wales | 2010 | Australia |
| Local Institution | Greenslopes | Queensland | 4120 | Australia |
| Local Institution | Adelaide | South Australia | 5000 | Australia |
| Local Institution | Fitzroy | Victoria | 3065 | Australia |
| Local Institution | Heidelberg | Victoria | 3084 | Australia |
| Local Institution | Fremantle | Western Australia | 6959 | Australia |
| Local Institution | Clayton | Australia |
| Local Institution | Calgary | Alberta | T2N 4Z6 | Canada |
| Local Institution | Vancouver | British Columbia | V5Z 1H2 | Canada |
| Local Institution | Vancouver | British Columbia | V6Z 2C7 | Canada |
| Local Institution | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Local Institution | Victoria | British Columbia | V8V 3P9 | Canada |
| Local Institution | Hamilton | Ontario | L8V 1C3 | Canada |
| Local Institution | Toronto | Ontario | M6H 3M1 | Canada |
| Local Institution | Montreal | Quebec | H2L 4P9 | Canada |
| Local Institution | Montreal | Quebec | H2X 2P4 | Canada |
| Local Institution | Montreal | Quebec | H3A 1T1 | Canada |
| Local Institution | Clichy | 92110 | France |
| Local Institution | Limoges | 87042 | France |
| Local Institution | Montpellier | 34295 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Pessac | 33604 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54511 | France |
| Fundacion De Investigacion De Diego | San Juan | 00927 | Puerto Rico |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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