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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003748-31 | EudraCT Number |
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The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Pegylated Interferon Lambda + Ribavirin | Experimental |
| |
| Arm 2: Pegylated Interferon Alfa-2a + Ribavirin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Interferon Lambda | Biological | Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response | At follow-up Week 24 (SVR24) following 48 weeks of treatment | |
| The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities | From Day 1 to end of Week 48 on-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms | From Day 1 to end of Week 48 on-treatment |
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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 |
|---|---|---|---|---|---|---|
| Local Institution | San Diego | California | 92114 | United States | ||
| Local Institution |
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| Pegylated Interferon Alfa-2a | Biological | Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks |
|
|
| Ribavirin | Drug | Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks |
|
|
| Rochester |
| New York |
| 14642 |
| United States |
| Local Institution | Houston | Texas | 77230 | United States |
| Local Institution | Vancouver | British Columbia | V5Z 1H2 | Canada |
| Local Institution | Vaughan | Ontario | L4L 4Y7 | Canada |
| Local Institution | Hong Kong | Hong Kong | 0 | China |
| Local Institution | Bogotá | Colombia |
| Local Institution | Cali | Colombia |
| Local Institution | Medellín | Colombia |
| Local Institution | Hradec Králové | 500 05 | Czechia |
| Local Institution | Prague | 140 21 | Czechia |
| Local Institution | Ústí nad Labem | 400 01 | Czechia |
| Local Institution | Shebin Elkom | Monufia Governorate | 35111 | Egypt |
| Local Institution | Cairo | 11559 | Egypt |
| Local Institution | Lai Chi Kok | Hong Kong |
| Local Institution | Tai Po | Hong Kong |
| Local Institution | Budapest | 1097 | Hungary |
| Local Institution | Budapest | 1126 | Hungary |
| Local Institution | Debrecen | 4043 | Hungary |
| Local Institution | Miskolc | 3529 | Hungary |
| Local Institution | Hyderabad | Andhra Pradesh | 500082 | India |
| Local Institution | Coimbatore | 641005 | India |
| Local Institution | Gurgaon | 122001 | India |
| Local Institution | Ludhiana | 141001 | India |
| Local Institution | Nagpur | 440010 | India |
| Local Institution | New Delhi | 110 070 | India |
| Local Institution | Dublin | Dublin | DUBLIN 7 | Ireland |
| Local Institution | Dublin | Dublin | Ireland |
| Local Institution | Amsterdam | 1105 AZ | Netherlands |
| Local Institution | Leiden | 2300 | Netherlands |
| Local Institution | Bialystok | 15-540 | Poland |
| Local Institution | Bydgoszcz | 85-030 | Poland |
| Local Institution | Chorzów | 41-500 | Poland |
| Local Institution | Czeladź | 41-250 | Poland |
| Local Institution | Kielce | 25-317 | Poland |
| Local Institution | Krakow | 31-501 | Poland |
| Local Institution | Lodz | 91-347 | Poland |
| Local Institution | Lublin | 20-081 | Poland |
| Local Institution | Olsztyn | 10-082 | Poland |
| Local Institution | Puławy | 24-100 | Poland |
| Local Institution | Racibórz | 47-400 | Poland |
| Local Institution | Sosnowiec | 41-200 | Poland |
| Local Institution | Warsaw | 01-201 | Poland |
| Local Institution | Wroclaw | 50-220 | Poland |
| Local Institution | Zielona Góra | 65-046 | Poland |
| Local Institution | Bucharest | 021105 | Romania |
| Local Institution | Iași | 700506 | Romania |
| Local Institution | Timișoara | 300002 | Romania |
| Local Institution | Yoshkar-Ola | Mariy-El Republic | 424006 | Russia |
| Local Institution | Kaluga | 248023 | Russia |
| Local Institution | Lipetsk | 398043 | Russia |
| Local Institution | Moscow | 111123 | Russia |
| Local Institution | Moscow | 115446 | Russia |
| Local Institution | Moscow | 117333 | Russia |
| Local Institution | Nizhny Novgorod | 603022 | Russia |
| Local Institution | Poselok Noviy | 143420 | Russia |
| Local Institution | Saint Petersburg | 191167 | Russia |
| Local Institution | Saint Petersburg | 193137 | Russia |
| Local Institution | Saint Petersburg | 194044 | Russia |
| Local Institution | Saint Petersburg | 196645 | Russia |
| Local Institution | Saint Petersburg | 198103 | Russia |
| Local Institution | Samara | 443077 | Russia |
| Local Institution | Saratov | 410009 | Russia |
| Local Institution | Smolensk | 214006 | Russia |
| Local Institution | Smolensk | 214018 | Russia |
| Local Institution | Tolyatti | 445846 | Russia |
| Local Institution | Volgograd | 400040 | Russia |
| Local Institution | Singapore | 119228 | Singapore |
| Local Institution | Singapore | 169608 | Singapore |
| Local Institution | Singapore | 308433 | Singapore |
| Local Institution | Singapore | 529889 | Singapore |
| Local Institution | Busan | 609-735 | South Korea |
| Local Institution | Busan | 614-735 | South Korea |
| Local Institution | Daegu | 700-721 | South Korea |
| Local Institution | Incheon | 400-711 | South Korea |
| Local Institution | Incheon | 403-720 | South Korea |
| Local Institution | Seoul | 110-744 | 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 | Suwon | 443-721 | South Korea |
| Local Institution | A Coruña | 15006 | Spain |
| Local Institution | Barcelona | 08003 | Spain |
| Local Institution | Barcelona | 08035 | Spain |
| Local Institution | Barcelona | 08036 | Spain |
| Local Institution | Madrid | 28046 | Spain |
| Local Institution | Taipei | Taiwan | 100 | Taiwan |
| Local Institution | Kaohsiung City | 80756 | Taiwan |
| Local Institution | Kaohsiung City | 833 | Taiwan |
| Local Institution | Taichung | 404 | Taiwan |
| Local Institution | Tainan | 704 | Taiwan |
| Local Institution | Taipei | 112 | Taiwan |
| Local Institution | Ankara | 06100 | Turkey (Türkiye) |
| Local Institution | Bornova Izmir | 35100 | Turkey (Türkiye) |
| Local Institution | Diyarbakır | 21280 | Turkey (Türkiye) |
| Local Institution | Istanbul | 34093 | Turkey (Türkiye) |
| Local Institution | Trabzon | 61080 | Turkey (Türkiye) |
| Local Institution | London | Greater London | W2 1NY | United Kingdom |
| Local Institution | Edinburgh | Midlothian | EH4 2XU | United Kingdom |
| Local Institution | Birmingham | West Midlands | B15 2TH | 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 |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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