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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004885-14 | EudraCT Number |
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The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir | Experimental |
| |
| Arm 2: pegIFNλ + Ribavirin + Daclatasvir | Experimental |
| |
| Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated interferon lambda (pegIFNλ) | Biological | Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12) | Post-treatment follow-up week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)] | On-treatment Week 4 | |
| Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3) |
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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 |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| Precision Research Institute, Llc |
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| Pegylated interferon lambda (pegIFNλ) | Biological | Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks |
|
|
| Pegylated interferon alfa-2a (pegIFNα-2a) | Biological | Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks |
|
|
| Ribavirin | Drug | Tablets, Oral, 400 mg, Twice daily, 24 weeks |
|
|
| Ribavirin | Drug | Tablets, Oral, 400 mg, Twice daily, 12 weeks |
|
|
| Daclatasvir | Drug | Tablets, Oral, 60 mg, Once daily, 12 weeks |
|
|
| Placebo matching Daclatasvir | Drug | Tablets, Oral, 0 mg, Once daily, 12 weeks |
|
Hb = Hemoglobin ANC = Absolute neutrophil count |
| Up to week 12 or week 24 |
| Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain) | Up to week 12 or week 24 |
| Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain) | Up to week 12 or week 24 |
| Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group | Post-treatment week 24 |
| Proportion of subjects with on-treatment Serious adverse events (SAEs) | Up to week 12 or week 24 |
| Proportion of subjects with dose reductions | Up to week 12 or week 24 |
| Proportion of subjects who discontinue due to Adverse events (AEs) | Up to week 12 or week 24 |
| Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection | Post-treatment follow-up week 12 |
| Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia) | Up to week 12 or week 24 |
| San Diego |
| California |
| 92114 |
| United States |
| Medical Associates Research Group | San Diego | California | 92123 | United States |
| University Of California, San Francisco/Sf General Hospital | San Francisco | California | 94110 | United States |
| Kaiser Permanente Medical Center | San Francisco | California | 94118 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06510 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Orlando Infectious Disease Center | Orlando | Florida | 32806 | United States |
| Gastrointestinal Specialists Of Georgia | Marietta | Georgia | 30060 | United States |
| The Queen'S Liver Center | Honolulu | Hawaii | 96813 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| Consultants For Clinical Research | Cincinnati | Ohio | 45249 | United States |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | United States |
| University Of Pittsburgh Medical Center, Ctr For Liver Diseases | Pittsburgh | Pennsylvania | 15213 | United States |
| Texas Clinical Research Institute, Llc | Arlington | Texas | 76012 | United States |
| St. Luke'S Episcopal Hospital - Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| Clinical Research Centers Of America | Murray | Utah | 84123 | United States |
| Local Institution | Autonoma | Buenos Aires | C1119ACN | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | C1280AEB | Argentina |
| Local Institution | Ciudad de Buenos Aires | Buenos Aires | C1121ABE | Argentina |
| Local Institution | Ciudad de Buenos Aires | Buenos Aires | C1181ACH | Argentina |
| Local Institution | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Local Institution | Quilmes | Buenos Aires | B1878DVB | Argentina |
| Local Institution | Córdoba | Córdoba Province | 5000 | Argentina |
| Local Institution | Prov de Santa Fe | Santa Fe Province | 2000 | Argentina |
| Local Institution | Camperdown | New South Wales | 2050 | Australia |
| Local Institution | Concord | New South Wales | 2139 | Australia |
| Local Institution | Darlinghurst | New South Wales | 2010 | Australia |
| Local Institution | Randwick | New South Wales | 2031 | Australia |
| Local Institution | Westmead Nsw | New South Wales | 2145 | Australia |
| Local Institution | Brisbane | Queensland | 4102 | Australia |
| Local Institution | Greenslopes | Queensland | 4120 | Australia |
| Local Institution | Herston | Queensland | 4029 | Australia |
| Local Institution | Adelaide | South Australia | 5000 | Australia |
| Local Institution | Clayton Vic | Victoria | 3168 | Australia |
| Local Institution | Fitzroy | Victoria | 3065 VIC | Australia |
| Local Institution | Melbourne | Victoria | 3004 | Australia |
| Local Institution | Parville | Victoria | 3050 | Australia |
| Local Institution | Fremantle | Western Australia | 6160 | Australia |
| Local Institution | Brussels | 1070 | Belgium |
| Local Institution | Leuven | 3000 | Belgium |
| Local Institution | Liège | 4000 | Belgium |
| Local Institution | Santiago | Santiago Metropolitan | Chile |
| Local Institution | Hus | 00029 | Finland |
| Local Institution | Clichy | 92118 | France |
| Local Institution | Créteil | 94010 | France |
| Local Institution | Montpellier | 34295 | France |
| Local Institution | Nice | 06202 | France |
| Local Institution | Athens | 115 23 | Greece |
| Local Institution | Thessaloniki | 54006 | Greece |
| Local Institution | Hong Kong | Hong Kong |
| Local Institution | Tai Po | Hong Kong |
| 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 | Fukuoka | Fukuoka | 8108563 | Japan |
| Local Institution | Fukuoka | Fukuoka | 8158555 | Japan |
| Local Institution | Kitakyushu | Fukuoka | 8030816 | Japan |
| Local Institution | Hiroshima | Hiroshima | 7348551 | Japan |
| Local Institution | Sapporo | Hokkaido | 0600033 | Japan |
| Local Institution | Kobe | Hyōgo | 6500047 | Japan |
| Local Institution | Tsuchiura-shi | Ibaraki | 300-0053 | Japan |
| Local Institution | Takamatsu | Kagawa-ken | 7608557 | Japan |
| Local Institution | Kagoshima | Kagoshima-ken | 8908520 | Japan |
| Local Institution | Kawasaki-shi | Kanagawa | 2138587 | Japan |
| Local Institution | Miyazaki | Miyazaki | 8800003 | Japan |
| Local Institution | Okayama | Okayama-ken | 7008558 | Japan |
| Local Institution | Saga | Saga-ken | 8408571 | Japan |
| Local Institution | Iruma-gun | Saitama | 3500495 | Japan |
| Local Institution | Saitama | Saitama | 3380001 | Japan |
| Local Institution | Bunkyo-ku | Tokyo | 1138655 | Japan |
| Local Institution | Minato-ku | Tokyo | 1058470 | Japan |
| Local Institution | Musashino-shi | Tokyo | 1808610 | Japan |
| Local Institution | Wakayama | Wakayama | 6408158 | Japan |
| Local Institution | Guadalajara | Jalisco | 44500 | Mexico |
| Local Institution | Guadalajara | Jalisco | 44650 | Mexico |
| Local Institution | Distrito Federal | Mexico City | 03720 | Mexico |
| Local Institution | Mexico City | Mexico City | 06726 | Mexico |
| Local Institution | Mexico City | Mexico City | 07760 | Mexico |
| Local Institution | Tlalpan | Mexico City | 14000 | Mexico |
| Local Institution | Guadalajara | Mexico |
| Local Institution | Mexico City | 06700 | Mexico |
| Local Institution | Amsterdam | 1105 AZ | Netherlands |
| Local Institution | Leiden | 2333 ZA | Netherlands |
| Local Institution | Auckland | 92024 | New Zealand |
| Local Institution | Chelyabinsk | 454052 | Russia |
| Local Institution | Irkutsk | 664003 | Russia |
| Local Institution | Krasnoyarsk | 660049 | Russia |
| Local Institution | Moscow | 107996 | Russia |
| Local Institution | Moscow | 117593 | Russia |
| Local Institution | Moscow | 119992 | Russia |
| Local Institution | Moscow | 121170 | Russia |
| Local Institution | Saint Petersburg | 190103 | Russia |
| Local Institution | Saint Petersburg | 194044 | Russia |
| Local Institution | Saint Petersburg | 197376 | Russia |
| Local Institution | Samara | 443063 | Russia |
| Local Institution | Smolensk | 214018 | Russia |
| Local Institution | Singapore | 119228 | Singapore |
| Local Institution | Singapore | 169608 | Singapore |
| Local Institution | Singapore | 529889 | Singapore |
| 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 | 425-707 | South Korea |
| Local Institution | Gyeonggi-do | 443-380 | 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 | Seoul | 138-736 | South Korea |
| Local Institution | Kaohsiung City | 80756 | Taiwan |
| Local Institution | Kaohsiung City | 833 | Taiwan |
| Local Institution | Taichung | 402 | Taiwan |
| Local Institution | Tainan | 704 | Taiwan |
| Local Institution | Yunlin | 64041 | Taiwan |
| Local Institution | Hull | Humberside | HU3 2JZ | United Kingdom |
| Local Institution | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
| Local Institution | Birmingham | West Midlands | B15 2TH | United Kingdom |
| Local Institution | London | E1 1BB | 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 |
|---|---|
| C000600496 | peginterferon lambda-1a |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| C549273 | daclatasvir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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