Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002458-66 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.
Masking is Double blind for RBV: two or more parties are unaware of the intervention assignment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive) | Experimental | Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Placebo matching Ribavirin 0mg tablet orally twice a day for 12 weeks |
|
| A2: DCV/ASV/BMS-791325 + RBV (naive) | Experimental | Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Ribavirin 200mg tablet orally twice a day for 12 weeks |
|
| A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced) | Experimental | Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Placebo matching Ribavirin 0 mg tablet orally twice a day for 12 weeks |
|
| A4: DCV/ASV/BMS-791325 + RBV (experienced) | Experimental | Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Ribavirin 200 mg tablet orally twice a day for 12 weeks, Weight based dosing: If < 75 kg, 1000 mg per day (two 200 mg tablets in AM and three 200 mg tablets in PM); if ≥ 75 kg, 1200 mg per day (three 200 mg tablets in AM and three 200 mg tablets in PM), AM=in the morning, PM=in the evening |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12) | SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) < Limit of Quantification (LOQ) target detected or target not detected (LOQ TD/TND) | Post treatment 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of treated subjects in each of the experienced arms with SVR12 | Post treatment 12 Week | |
| Proportion of subjects in each arm who achieve HCV RNA < LOQ TD/TND | Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24) |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|
| 25942724 | Derived | Muir AJ, Poordad F, Lalezari J, Everson G, Dore GJ, Herring R, Sheikh A, Kwo P, Hezode C, Pockros PJ, Tran A, Yozviak J, Reau N, Ramji A, Stuart K, Thompson AJ, Vierling J, Freilich B, Cooper J, Ghesquiere W, Yang R, McPhee F, Hughes EA, Swenson ES, Yin PD. Daclatasvir in combination with asunaprevir and beclabuvir for hepatitis C virus genotype 1 infection with compensated cirrhosis. JAMA. 2015 May 5;313(17):1736-44. doi: 10.1001/jama.2015.3868. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Asunaprevir | Drug |
|
|
| BMS-791325 | Drug |
|
| Ribavirin | Drug |
|
|
| Placebo matching Ribavirin | Drug |
|
| Proportion of subjects in each arm who achieve HCV RNA < LOQ TND | Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8), 12 (SVR12) and 24 (SVR24) |
| Safety as measured by frequency of Serious Adverse Events(SAEs)and discontinuations due to Adverse Events(AEs) | Up to end of treatment (week 12) + 7 days |
| Proportion of subjects with anemia defined as Hg < 10 g/dL on-treatment and Hg ≥ 10 g/dL at baseline in each arm within each cohort | Up to end of treatment (week 12) + 7 days |
| Differences in rates of selected Grade 3 - 4 laboratory test result abnormalities | Up to end of treatment (week 12) + 7 days |
| Proportion of subjects achieving SVR12 associated with HCV geno subtype 1a vs 1b | Post treatment 12 Week |
| Proportion of subjects in each arm achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism(SNP) status (CC genotype or non-CC genotype) | Post treatment 12 Week |
| 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 | Chicago | Illinois | 60637 | United States |
| Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| Kansas City Care Clinic | Kansas City | Missouri | 64111 | United States |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | United States |
| Binghamton Gastroenterology Associates | Binghamton | New York | 13903 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | 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 |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18102 | United States |
| Quality Medical Research Pllc | Nashville | Tennessee | 37211 | United States |
| Advanced Liver Therapies | 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 |
| 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 | Clayton | Victoria | 3168 | Australia |
| Local Institution | Fitzroy | Victoria | 3065 | Australia |
| Local Institution | Heidelberg | Victoria | 3084 | Australia |
| Local Institution | Fremantle | Western Australia | 6160 | 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 | Créteil | 94010 | France |
| Local Institution | Marseille | 13285 | France |
| Local Institution | Montpellier | 34000 | France |
| Local Institution | Nice | 06202 | France |
| Local Institution | Paris | 75013 | France |
| Local Institution | Paris | 75571 | France |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C549273 | daclatasvir |
| C571889 | asunaprevir |
| C587012 | 8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided