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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005446-35 | EudraCT Number |
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The purpose of this study is to estimate 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, for subjects who are prior null or partial responders to P/R or who are treatment-naive.
Allocation: Treatment naive cohort: Randomized Controlled Trial, Null/partial responder and intolerant/ineligible cohorts: N/A (Single arm study)
Masking: Treatment naive cohort: Double Blind, Null/partial responder and intolerant/ineligible cohorts: Open
Intervention Model: Treatment naive cohort: Parallel, Null/partial responder and intolerant/ineligible cohorts: Single group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Null or Partial Responder to P/R (ASV + DCV) | Experimental | Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks |
|
| Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV) | Experimental | Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks |
|
| Arm 3: Treatment naive (ASV + DCV) | Experimental | [Subjects will receive ASV + DCV for 24 weeks] followed by ASV + DCV for 24 weeks in protocol AI444026] Subjects meeting prespecified rescue criteria in the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R) Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks Daclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks Pegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks Ribavirin 1000 mg/1200 mg (total daily dose) tablet by mouth for 24 or 48 weeks |
|
| Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week | Experimental | Subjects meeting prespecified rescue criteria in the null or partial responder cohort or active arm of the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R) Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks Daclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks Pegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks Ribavirin 1000 mg / 1200 mg (total daily dose) Tablet by mouth, for 24 or 48 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asunaprevir (ASV) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive | At 12 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are intolerant or ineligible to P/R | Post-treatment Week 12 | |
| On treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) |
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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 |
|---|---|---|---|---|---|---|
| The Health Care Authority For Baptist Health | Montgomery | Alabama | 36116 | United States | ||
| Scripps Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27009831 | Derived | Kao JH, Lee YJ, Heo J, Ahn SH, Lim YS, Peng CY, Chang TT, Torbeyns A, Hughes E, Bhore R, Noviello S. All-oral daclatasvir plus asunaprevir for chronic hepatitis C virus (HCV) genotype 1b infection: a sub-analysis in Asian patients from the HALLMARK DUAL study. Liver Int. 2016 Oct;36(10):1433-41. doi: 10.1111/liv.13128. Epub 2016 Apr 28. | |
| 26683763 |
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| Daclatasvir (DCV) | Drug |
|
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| Pegylated-interferon alfa 2a (PegIFN) | Drug |
|
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| Ribavirin (RBV) | Drug |
|
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| End of Treatment (up to 48 weeks) plus 7 days |
| Differences in rates of selected grade 3-4 laboratory abnormalities during the first 12 weeks between treatments (ASV + DCV vs PBO) for naive subjects | Up to first 12 weeks |
| Proportion of genotype 1b subjects with SVR12 (HCV RNA < LOQ at post treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene for each cohort | Post-treatment Week 12 |
| Proportion of genotype 1b subjects with HCV RNA undetectable | eRVR = Extended rapid virologic response, EOT = End of treatment | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 12, or post-treatment Week 24 for each cohort |
| Proportion of genotypes 1b subjects with HCV RNA < LOQ | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [VR(4&12)]; EOT (up to 24 weeks), post-treatment Week 24 (SVR24) for each cohort |
| Proportion of subjects with anemia | At 12 weeks post-treatment |
| Proportion of subjects with rash | At 12 weeks post-treatment |
| La Jolla |
| California |
| 92037 |
| United States |
| Scpmg/ Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| University Of Colorado Denver And Hospital | Aurora | Colorado | 80045 | United States |
| Uf Hepatology Research At Ctrb | Gainesville | Florida | 32610 | United States |
| Johns Hopkins Medical Institutions | Lutherville | Maryland | 21093 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | United States |
| North Shore-Long Island Jewish Health System | Manhasset | New York | 11030 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| University Of North Carolina At Chapel Hill School Of Med | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| Vamc | Houston | Texas | 77030 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Dean Clinic | Madison | Wisconsin | 53715 | United States |
| Local Institution | Buenos Aires | Buenos Aires | 1119 | Argentina |
| Local Institution | Ciudad de Buenos Aires | Buenos Aires | C1181ACH | Argentina |
| Local Institution | Prov de Santa Fe | Santa Fe Province | 2000 | Argentina |
| Local Institution | Darlinghurst | New South Wales | 2010 | Australia |
| Local Institution | Kogarah | New South Wales | 2217 | Australia |
| Local Institution | Randwick | New South Wales | 2070 | Australia |
| Local Institution | Fitzroy | Queensland | 3065 VIC | Australia |
| Local Institution | Adelaide | South Australia | 5000 | Australia |
| Local Institution | Bedford Park, Sa | South Australia | 5042 | Australia |
| Local Institution | Clayton | Victoria | 3168 | Australia |
| Local Institution | Heidelberg | Victoria | 3084 | Australia |
| Local Institution | Melbourne | Victoria | 3004 | Australia |
| Local Institution | Fremantle | Western Australia | 6160 | Australia |
| Local Institution | Nedlands | Western Australia | 6009 | Australia |
| Local Institution | Perth | Western Australia | 6001 | Australia |
| Local Institution | Graz | 8036 | Austria |
| Local Institution | Linz | 4010 | Austria |
| Local Institution | Salzburg | 5020 | Austria |
| Local Institution | Vienna | 1090 | Austria |
| Local Institution | Vienna | 1160 | Austria |
| Gastrointestinal Research Institute (G.I.R.I.) | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Percuro Clinical Research Ltd | Victoria | British Columbia | V8V 3P9 | Canada |
| Toronto General Hospital-University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
| Toronto Liver Centre | Toronto | Ontario | M6H 3M1 | Canada |
| Toronto Digestive Disease Associates, Inc. | Vaughan | Ontario | L4L 4Y7 | Canada |
| Clinique Medicale Lactuel | Montreal | Quebec | H2L 4P9 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Alpha-Recherche Clinique | Québec | Quebec | G3K 2P8 | Canada |
| Local Institution | Clichy | 92118 | France |
| Local Institution | Créteil | 94000 | France |
| Local Institution | Lyon | 69317 | France |
| Local Institution | Marseille | 13285 | France |
| Local Institution | Paris | 75014 | France |
| Local Institution | Paris | 75651 | France |
| Local Institution | Toulouse | 31059 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution | Berlin | 12157 | Germany |
| Local Institution | Berlin | 13353 | Germany |
| Local Institution | Bonn | 53105 | Germany |
| Local Institution | Essen | 45147 | Germany |
| Local Institution | Frankfurt | 60590 | Germany |
| Local Institution | Hamburg | 20246 | Germany |
| Local Institution | Hanover | 30623 | Germany |
| Local Institution | München | 81377 | Germany |
| Local Institution | Dublin | Dublin | DUBLIN 7 | Ireland |
| Local Institution | Dublin | Dublin | DUBLIN 8 | Ireland |
| Local Institution | Haifa | 31096 | Israel |
| Local Institution | Jerusalem | 91031 | Israel |
| Local Institution | Jerusalem | 91120 | Israel |
| Local Institution | Tel Aviv | 64239 | Israel |
| Local Institution | Tel Litwinsky | 52621 | Israel |
| Local Institution | Zafed | 13110 | Israel |
| Local Institution | Messina | 98124 | Italy |
| Local Institution | Milan | 20121 | Italy |
| Local Institution | Roma | 00161 | Italy |
| Local Institution | Torino | 10126 | Italy |
| Local Institution | Amsterdam | 1105 AZ | Netherlands |
| Local Institution | Leiden | 2300 RC | Netherlands |
| Local Institution | Rotterdam | 3015 CE | Netherlands |
| Local Institution | Auckland | 92024 | New Zealand |
| Local Institution | Hamilton | 3240 | New Zealand |
| Local Institution | Wellington | 6021 | New Zealand |
| Local Institution | Bialystok | 15-540 | Poland |
| Local Institution | Wroclaw | 50-349 | Poland |
| Local Institution | Chelyabinsk | 454052 | Russia |
| Local Institution | Krasnoyarsk | 660049 | Russia |
| Local Institution | Moscow | 111123 | Russia |
| Local Institution | Moscow | 115446 | Russia |
| Local Institution | Saint Petersburg | 190103 | Russia |
| Local Institution | Samara | 443077 | Russia |
| Local Institution | Smolensk | 214018 | Russia |
| Local Institution | Tyumen | 625026 | Russia |
| Local Institution | Busan | 602-715 | South Korea |
| Local Institution | Busan | 602-739 | South Korea |
| Local Institution | Busan | 614-735 | South Korea |
| Local Institution | Daegu | 700-721 | South Korea |
| Local Institution | Daegu | 705-703 | South Korea |
| Local Institution | Gyeonggi-do | 420-767 | South Korea |
| Local Institution | Gyeongsangnam-do | 626-770 | South Korea |
| Local Institution | Incheon | 400-711 | South Korea |
| Local Institution | Incheon | 403-720 | South Korea |
| Local Institution | Seoul | 110-774 | South Korea |
| Local Institution | Seoul | 120-752 | South Korea |
| Local Institution | Seoul | 135-710 | South Korea |
| Local Institution | Seoul | 138-736 | South Korea |
| Local Institution | Alicante | 03010 | Spain |
| Local Institution | Barcelona | 08028 | Spain |
| Local Institution | Madrid | 28222 | Spain |
| Local Institution | Valencia | 46009 | Spain |
| Local Institution | Taichung | 402 | Taiwan |
| Local Institution | Taichung | 40447 | Taiwan |
| Local Institution | Tainan | 704 | Taiwan |
| Local Institution | Taipei | 100 | Taiwan |
| Local Institution | Taipei | 112 | Taiwan |
| Local Institution | London | Greater London | NW3 2QG, | United Kingdom |
| Local Institution | London | Greater London | SW17 0QT | United Kingdom |
| Local Institution | Manchester | Greater Manchester | M8 6RL | United Kingdom |
| Local Institution | Glasgow | Lanarkshire | G12 0YN | United Kingdom |
| 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. |
| 25078304 | Derived | Manns M, Pol S, Jacobson IM, Marcellin P, Gordon SC, Peng CY, Chang TT, Everson GT, Heo J, Gerken G, Yoffe B, Towner WJ, Bourliere M, Metivier S, Chu CJ, Sievert W, Bronowicki JP, Thabut D, Lee YJ, Kao JH, McPhee F, Kopit J, Mendez P, Linaberry M, Hughes E, Noviello S; HALLMARK-DUAL Study Team. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet. 2014 Nov 1;384(9954):1597-605. doi: 10.1016/S0140-6736(14)61059-X. Epub 2014 Jul 28. |
| 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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| ID | Term |
|---|---|
| C571889 | asunaprevir |
| C549273 | daclatasvir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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