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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005422-21 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin | Experimental | Asunaprevir: Capsule, Oral, 100 mg, Twice daily, 24 weeks Daclatasvir: Tablet, Oral, 60 mg, Once daily, 24 weeks Peg-interferon Alfa-2a: Injection, subcutaneous (SC), 180 mcg/0.5 mL, Once weekly, 24 weeks Ribavirin: Tablet, Oral, 1000 mg/1200 mg (total daily dose), 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asunaprevir | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 12 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| On-treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) through the end of treatment | Through the end of treatment (maximum up to 24 weeks) plus 7 days | |
| Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 gene |
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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 |
|---|---|---|---|---|---|---|
| Alabama Liver & Digestive Specialists (Alds) | Montgomery | Alabama | 36116 | United States | ||
| Scripps Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25703086 | Derived | 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. |
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| Daclatasvir |
| Drug |
|
|
| Peg-interferon Alfa-2a | Drug |
|
|
| Ribavirin | Drug |
|
|
| At post-treatment Week 12 |
| Proportion of subjects with HCV RNA undetectable | 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 |
| Proportion of subjects with HCV RNA < LOQ | 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) |
| Proportion of patients with SVR12 (HCV RNA < LOQ at post-treatment Week 12) for HCV genotype 4 subjects | Post-treatment Week 12 |
| 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 |
| South Denver Gastroenterology, Pc | Englewood | Colorado | 80113 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| University Of Miami Schiff Center For Liver Diseases | Miami | Florida | 33136 | United States |
| University Of Chicago Medical Center | Chicago | Illinois | 60637-1432 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| University Of North Carolina At Chapel Hill School Of Med | Chapel Hill | North Carolina | 27599-7584 | United States |
| University Of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Options Health Research, Llc | Tulsa | Oklahoma | 74104 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Mcguire Dvamc | Richmond | Virginia | 23249 | United States |
| Dean Clinic | Madison | Wisconsin | 53715 | United States |
| Local Institution | Ciudad de Buenos Aires | Buenos Aires | C1121ABE | Argentina |
| Local Institution | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Local Institution | Prov. Buenos Aires | Buenos Aires | 1629 | Argentina |
| Local Institution | Edmonton | Alberta | T6G 2B7 | Canada |
| Local Institution | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Local Institution | Victoria | British Columbia | V8V 3P9 | Canada |
| Local Institution | Toronto | Ontario | M6H 3M1 | Canada |
| Local Institution | Montreal | Quebec | H2L 4P9 | Canada |
| Local Institution | Aalborg | 9100 | Denmark |
| Local Institution | Hvidovre | 2650 | Denmark |
| Local Institution | Odense | 5000 | Denmark |
| Local Institution | Créteil | 94000 | France |
| Local Institution | Montpellier | 34295 | France |
| Local Institution | Nice | 06202 | France |
| Local Institution | Paris | 75571 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Pessac | 33604 | France |
| Local Institution | Berlin | 13353 | Germany |
| Local Institution | Düsseldorf | 40237 | Germany |
| Local Institution | Frankfurt | 60590 | Germany |
| Local Institution | Freiburg im Breisgau | 79106 | Germany |
| Local Institution | Hamburg | 20246 | Germany |
| Local Institution | Heidelberg | 69120 | Germany |
| Local Institution | Tübingen | 72076 | Germany |
| Local Institution | Brescia | 25123 | Italy |
| Local Institution | Cisanello (pisa) | 56124 | Italy |
| Local Institution | Milan | 20122 | Italy |
| Local Institution | Palermo | 90127 | Italy |
| Local Institution | Mexico City | Mexico City | 03720 | Mexico |
| Local Institution | México | State of Mexico | 06700 | Mexico |
| Local Institution | Amsterdam | 1105 AZ | Netherlands |
| Local Institution | Rotterdam | 3015 CE | Netherlands |
| Local Institution | Moscow | 117593 | Russia |
| Local Institution | Moscow | 127015 | Russia |
| Local Institution | Saint Petersburg | 194044 | Russia |
| Local Institution | Stavropol | 355000 | Russia |
| Local Institution | Tyumen | 625026 | Russia |
| Local Institution | Bucheon-si | 420-767 | South Korea |
| 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 | Gyeongsangnam-do | 626-770 | South Korea |
| Local Institution | Incheon | 400-711 | South Korea |
| Local Institution | Incheon | 403-720 | South Korea |
| Local Institution | Seoul | 120-752 | South Korea |
| Local Institution | Seoul | 135-710 | South Korea |
| Local Institution | Alcorcón | 28922 | Spain |
| Local Institution | Barcelona | 08916 | Spain |
| Local Institution | Madrid | 28029 | Spain |
| Local Institution | Seville | 41014 | Spain |
| Local Institution | Gvteborg | SE-41685 | Sweden |
| Local Institution | Stockholm | 141 86 | Sweden |
| Local Institution | Bern | 3010 | Switzerland |
| Local Institution | Lausanne | 1011 | Switzerland |
| Local Institution | Chiayi City | 600 | Taiwan |
| Local Institution | Kaohsiung City | 807 | Taiwan |
| Local Institution | Taichung | 40705 | Taiwan |
| Local Institution | Taipei | 11217 | Taiwan |
| 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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