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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005293-31 | 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 BMS-914143 and achieved sustained virologic response
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects treated with Peginterferon Lambda-1a (BMS-914143) | Subjects who participated in a clinical trial in which Peginterferon Lambda-1a (BMS-914143) was administered for the treatment of chronic hepatitis C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon Lambda-1a (BMS-914143) | Drug | Observational study - No Intervention [subjects were previously treated with Peginterferon Lambda-1a (BMS-914143)] |
|
| Measure | Description | Time Frame |
|---|---|---|
| Durability of virologic response (time to loss of virologic response) | Durability of virologic response as assessed by the time to loss of virologic response in subjects treated in a previous study with BMS-914143 who have HCV RNA less than the limit of quantitation of the assay (< LOQ) at the completion of the required post-treatment follow-up in the previous study. Loss of virologic response assessed using HCV RNA at 24-week intervals | 24 week intervals from end of treatment in parent study up to 144 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term progression of liver disease | Long-term progression of liver disease as measured by laboratory indicators of hepatic status and function, all-cause mortality and liver related mortality in subjects previously treated with BMS-914143 who have HCV RNA < LOQ at the completion of the required post-treatment follow-up in the parent study | 24 week intervals up to 144 weeks |
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Inclusion Criteria:
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Subjects who participated in a clinical trial in which BMS-914143 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 |
|---|---|---|---|---|---|---|
| Scripps Clinic | La Jolla | California | 92037 | United States | ||
| Yale University School Of Medicine |
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| Duration of persistence of anti-Lambda antibodies in subjects who are positive for anti-Lambda antibodies at end of treatment in the parent study | 24 week intervals up to 144 weeks |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Gastrointestinal Specialists Of Georgia | Marietta | Georgia | 30060 | United States |
| The Queen'S Medical Center | Honolulu | Hawaii | 96813 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Consultants For Clinical Research | Cincinnati | Ohio | 45249 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| St. Luke'S Episcopal Hospital - Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| University Of Texas Health Science Center At Houston | Houston | Texas | 77030 | United States |
| Va Medical Center (151) | Houston | Texas | 77030 | United States |
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Clinical Research Centers Of America | Murray | Utah | 84123 | United States |
| Metropolitan Research | Annandale | Virginia | 22003 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Local Institution | Buenos Aires | Buenos Aires | 1119 | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | 1121 | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | 1181 | Argentina |
| Local Institution | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Local Institution | Rosario | Santa Fe Province | 2000 | Argentina |
| Local Institution | Buenos Aires | 1221 | Argentina |
| Local Institution | Camperdown | New South Wales | 2050 | Australia |
| Local Institution | Darlinghurst | New South Wales | 2010 | Australia |
| Local Institution | Randwick | New South Wales | 2031 | Australia |
| Local Institution | Sydney | New South Wales | 2139 | Australia |
| Local Institution | Westmead | New South Wales | 2145 | Australia |
| Local Institution | Greenslopes | Queensland | 4120 | Australia |
| Local Institution | Herston | Queensland | 4029 | Australia |
| Local Institution | Woolloongabba | Queensland | 4102 | Australia |
| Local Institution | Adelaide | South Australia | 5000 | Australia |
| Local Institution | Fitzroy | Victoria | 3065 VIC | Australia |
| Local Institution | Heidelberg | Victoria | 3084 | Australia |
| Local Institution | Melbourne | Victoria | 3004 | Australia |
| Local Institution | Parkville | Victoria | 3050 | Australia |
| Local Institution | Vienna | 1090 | Austria |
| Local Institution | Leuven | 3000 | Belgium |
| Local Institution | Liège | 4000 | Belgium |
| Toronto Digestive Disease Associates, Inc. | Vaughan | Ontario | L4L 4Y7 | Canada |
| Local Institution | Hus | 00029 | Finland |
| Local Institution | Clichy | 92118 | France |
| Local Institution | Créteil | 9410 | 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 | Hamburg | 20246 | Germany |
| Local Institution | Heidelberg | 69120 | Germany |
| Local Institution | Athens | 10676 | Greece |
| Local Institution | Thessaloniki | 54006 | Greece |
| Local Institution | Cisanello (pisa) | 56124 | Italy |
| Local Institution | Florence | 50134 | Italy |
| Local Institution | Milan | 20122 | Italy |
| Local Institution | Milan | 20142 | Italy |
| Local Institution | Naples | 80131 | Italy |
| Local Institution | Novara | 28100 | Italy |
| Local Institution | Viale Del Policlinico, 155 | 00161 | Italy |
| Local Institution | Guadalajara | Jalisco | 44650 | Mexico |
| Local Institution | Amsterdam | 1105 AZ | Netherlands |
| Local Institution | Leiden | 2333 ZA | Netherlands |
| Local Institution | Auckland | 92024 | New Zealand |
| Local Institution | Bialystok | 15-540 | Poland |
| Local Institution | Krakow | 31-202 | Poland |
| Local Institution | Wroclaw | 50-220 | Poland |
| Local Institution | San Juan | 00927 | Puerto Rico |
| Local Institution | Bucharest | 30303 | Romania |
| Local Institution | Bucharest | 50524 | Romania |
| Local Institution | Iași | 700506 | Romania |
| Local Institution | Timișoara | 300 002 | Romania |
| Local Institution | Busan | 614-735 | South Korea |
| Local Institution | Barcelona | 08003 | Spain |
| Local Institution | Barcelona | 08035 | Spain |
| Local Institution | Valencia | 46010 | Spain |
| 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 |
|---|---|
| C000600496 | peginterferon lambda-1a |
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