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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005287-21 | EudraCT Number |
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The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with chronic hepatitis C | Subjects who participated in a clinical trial in which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) was administered for the treatment of chronic hepatitis C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) | Drug | Observational study - No Intervention [(subjects were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)] |
| Measure | Description | Time Frame |
|---|---|---|
| Durability of Sustained viral response [SVR] (time to loss of virologic response) | The durability of virologic response, as assessed by the time to loss of virologic response after achieving sustained viral response (SVR12) in a previous study with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052). Loss of virologic response assessed using Hepatitis C virus (HCV) Ribonucleic acid (RNA) | 24 or 48-week Intervals |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of viral genotypic substitutions in subjects previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) who did not achieve or did not maintain SVR12 | 24 or 48-week intervals | |
| Long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all cause mortality, and liver-related mortality |
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Inclusion Criteria
Exclusion Criteria:
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Subjects who participated in a clinical trial in which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) was administered for the treatment of chronic hepatitis C
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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 | ||
| Pacific Oaks Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28941023 | Derived | Reddy KR, Pol S, Thuluvath PJ, Kumada H, Toyota J, Chayama K, Levin J, Lawitz EJ, Gadano A, Ghesquiere W, Gerken G, Brunetto MR, Peng CY, Silva M, Strasser SI, Heo J, McPhee F, Liu Z, Yang R, Linaberry M, Noviello S. Long-term follow-up of clinical trial patients treated for chronic HCV infection with daclatasvir-based regimens. Liver Int. 2018 May;38(5):821-833. doi: 10.1111/liv.13596. Epub 2017 Oct 12. |
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| 24 or 48-week intervals |
| Beverly Hills |
| California |
| 90211-2145 |
| United States |
| Southern California Research Center | Coronado | California | 92118 | United States |
| Scripps Clinic | La Jolla | California | 92037 | United States |
| Keck Medical Center of USC, HCC 1 | Los Angeles | California | 90033 | United States |
| Peter J Ruane Md Inc | Los Angeles | California | 90036 | United States |
| Anthony M. Mills Md Inc | Los Angeles | California | 90069 | United States |
| Precision Research Institute, Llc | San Diego | California | 92114 | United States |
| Quest Clinical Research | San Diego | California | 92120 | United States |
| Medical Associates Research Group | San Diego | California | 92123 | United States |
| U.Cal.-San Francisco | San Francisco | California | 94143 | United States |
| University Of Colorado Denver & Hospital | Aurora | Colorado | 80045 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06520-8019 | United States |
| Schiff Center for Liver Diseases | Miami | Florida | 33136 | United States |
| University Of Miami School Of Medicine | Miami | Florida | 33136 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Florida Hospital Transplant Center | Orlando | Florida | 32804 | United States |
| Gastrointestinal Specialists Of Georgia | Marietta | Georgia | 30060 | United States |
| Ruth M. Rothstein CORE Center | Chicago | Illinois | 60612 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Digestive Disease Associates, P.A. | Catonsville | Maryland | 21228 | United States |
| Johns Hopkins University | Lutherville | Maryland | 21093 | United States |
| The Research Institute | Springfield | Massachusetts | 01105 | United States |
| University Of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| Southwest Care Center | Santa Fe | New Mexico | 87505 | United States |
| Nyu Medical Center | Great Neck | New York | 11021 | United States |
| University Of North Carolina At Chapel Hill School Of Med | Chapel Hill | North Carolina | 27599-7584 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| Carolinas Center For Liver Disease | Statesville | North Carolina | 28677 | United States |
| Mayo Clinic Rochester | Tulsa | Oklahoma | 74104 | United States |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18102 | United States |
| University Of Pennsylvania School Of Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| Liver Associates Of Texas | Houston | Texas | 77030 | United States |
| MEDVAMC | Houston | Texas | 77030 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | United States |
| Metropolitan Research | Annandale | Virginia | 22003 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Bon Secours St. Mary's Hospital of Richmond, Inc. | Richmond | Virginia | 23226 | United States |
| Mcguire Dvamc | Richmond | Virginia | 23249 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Ssm Health Dean Med Group | Madison | Wisconsin | 53715 | United States |
| Fundacion Cidea De Paraguay | Ciudad de Buenos Aires | Buenos Aires | C1121ABE | Argentina |
| Centro Oncologico Integral | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Hospital Austral | Prov. Buenos Aires | Buenos Aires | 1629 | Argentina |
| Instituto Centralizado De Asistencia E Investigacion Clinica | Prov de Santa Fe | Santa Fe Province | 2000 | Argentina |
| Local Institution | Buenos Aires | 1119 | Argentina |
| Hospital Italiano De Buenos Aires | Buenos Aires | C1181 | Argentina |
| Local Institution | Camperdown | New South Wales | 2050 | Australia |
| Local Institution | Darlinghurst | New South Wales | 2010 | Australia |
| Local Institution | Darlinghurst Nsw | New South Wales | 2010 | Australia |
| Local Institution | Randwick | New South Wales | 2031 | Australia |
| Local Institution | Westmead | New South Wales | 2145 | Australia |
| Local Institution | Woollongabba | Queensland | 4102 | Australia |
| Local Institution | Adelaide | South Australia | 5000 | Australia |
| Local Institution | Clayton Vic | Victoria | 3168 | Australia |
| Local Institution | Melbourne | Victoria | 3004 | Australia |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Local Institution | Rio de Janeiro | 20270-004 | Brazil |
| Local Institution | Rio de Janeiro | 21040-000 | Brazil |
| Local Institution | São Paulo | 04035-970 | Brazil |
| Local Institution | Calgary | Alberta | T2N 4Z6 | Canada |
| Local Institution | Edmonton | Alberta | T6G 2B7 | Canada |
| Local Institution | Vancouver | British Columbia | V6Z 2C7 | Canada |
| Local Institution | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Local Institution | Victoria | British Columbia | V8V 3M9 | Canada |
| Local Institution | Toronto | Ontario | M5G 2C4 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Local Institution | Regina | Saskatchewan | S4P 0W5 | Canada |
| Local Institution | Hvidovre | 2650 | Denmark |
| Local Institution | Odense | 5000 | Denmark |
| Local Institution | Clichy | 92118 | France |
| Local Institution | Créteil | 94010 | France |
| Local Institution | La Roche-sur-Yon | 85925 | France |
| Local Institution | Lille | 59037 | France |
| Local Institution | Limoges | 87042 | France |
| Local Institution | Lyon | 69317 | France |
| Local Institution | Marseille | 13285 | France |
| Local Institution | Montpellier | 34295 | France |
| Local Institution | Nice | 06202 | France |
| Local Institution | Paris | 75571 | France |
| Local Institution | Paris | 75651 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Pessac | 33604 | France |
| Local Institution | Toulouse | 31059 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution | Düsseldorf | 40237 | Germany |
| Local Institution | Essen | 45122 | Germany |
| Local Institution | Frankfurt | 60590 | Germany |
| Local Institution | Hamburg | 20099 | Germany |
| Local Institution | Hanover | 30625 | Germany |
| Local Institution | Heidelberg | 69120 | Germany |
| Local Institution | Mainz | 55101 | Germany |
| Mater Misericordiae University Hospital | Dublin | Dublin | Ireland |
| St. James'S Hospital | Dublin | Dublin | Ireland |
| Local Institution | Brescia | 25123 | Italy |
| Local Institution | Cisanello (pisa) | 56124 | Italy |
| Local Institution | Milan | 20127 | Italy |
| Local Institution | Pavia | 27100 | Italy |
| Local Institution | Torino | 10126 | Italy |
| Local Institution | Viale Del Policlinico, 155 | 00161 | Italy |
| Local Institution | Nagoya | Aichi-ken | 4668560 | Japan |
| Local Institution | Chiba | Chiba | 2608677 | Japan |
| Local Institution | Fukuoka | Fukuoka | 8108563 | Japan |
| Local Institution | Kurume | Fukuoka | 8300011 | Japan |
| Local Institution | Ogaki-shi | Gifu | 5038502 | Japan |
| Local Institution | Hiroshima | Hiroshima | 7340037 | Japan |
| Local Institution | Sapporo | Hokkaido | 0600033 | Japan |
| Local Institution | Amagasaki-shi | Hyōgo | 6608511 | Japan |
| Local Institution | Kanazawa | Ishikawa-ken | 9208641 | Japan |
| Local Institution | Takamatsu | Kagawa-ken | 7608557 | Japan |
| Local Institution | Kagoshima | Kagoshima-ken | 8908520 | Japan |
| Local Institution | Kawasaki-shi | Kanagawa | 2138587 | Japan |
| Local Institution | Sendai | Miyagi | 9808574 | Japan |
| Local Institution | Okayama | Okayama-ken | 7008558 | Japan |
| Local Institution | Osaka | Osaka | 5458586 | Japan |
| Local Institution | Osaka-sayama-shi | Osaka | 5898511 | Japan |
| Local Institution | Suita | Osaka | 5640013 | Japan |
| Local Institution | Suita-shi | Osaka | 5650871 | Japan |
| Local Institution | Iruma-gun | Saitama | 3500495 | Japan |
| Local Institution | Bunkyo-ku | Tokyo | 1138655 | Japan |
| Local Institution | Minato-ku | Tokyo | 1058470 | Japan |
| Local Institution | Musashino-shi | Tokyo | 1808610 | Japan |
| Local Institution | Shinagawa-ku | Tokyo | 1428666 | Japan |
| Local Institution | Chuo-shi | Yamanashi | 4093898 | Japan |
| Local Institution | Guadalajara | Jalisco | 44160 | Mexico |
| Local Institution | Cuernavaca | Morelos | 62260 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64710 | Mexico |
| Local Institution | Bialystok | 15-540 | Poland |
| Local Institution | San Juan | 00927 | Puerto Rico |
| Local Institution | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| Local Institution | Busan | 47392 | South Korea |
| Local Institution | Busan | 49241 | South Korea |
| Local Institution | Busan | 602-715 | South Korea |
| Local Institution | Alicante | 03010 | Spain |
| Local Institution | Barcelona | 08035 | Spain |
| Local Institution | Barcelona | 08916 | Spain |
| Local Institution | Madrid | 28007 | Spain |
| Local Institution | Madrid | 28046 | Spain |
| Local Institution | Madrid | 28222 | Spain |
| Local Institution | Madrid | 28922 | Spain |
| Local Institution | Málaga | 29071 | Spain |
| Local Institution | Santiago de Compostela | 15706 | Spain |
| Local Institution | Seville | 41014 | Spain |
| Local Institution | Valencia | 46010 | Spain |
| Local Institution | Gothenburg | SE-416 85 | Sweden |
| Local Institution | Stockholm | 141 86 | Sweden |
| Local Institution | Taichung | 40447 | Taiwan |
| Kings College Hospital | London | Greater London | SE5 9RS | United Kingdom |
| Local Institution | London | Greater London | SW17 0QT | United Kingdom |
| Imperial College London | London | Greater London | W2 1NY | United Kingdom |
| North Manchester General Hospital | Manchester | Greater Manchester | M8 6RL | United Kingdom |
| Gartnaval General Hospital | Glasgow | G12 0YN | United Kingdom |
| 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 |
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