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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005409-65 | EudraCT Number |
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The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon Lambda-1a + Ribavirin + Daclatasvir | Experimental | Peginterferon Lambda-1a 180 µg solution for subcutaneous injection, once a week for 24 Weeks Ribavirin 200 mg tablets [1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects < 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food] by mouth, twice daily, for 24 weeks Daclatasvir 60 mg tablets by mouth, once a day for 12 weeks |
|
| Peginterferon Alfa-2a + Ribavirin + Telaprevir | Experimental | Peginterferon Alfa-2a 180 µg solution for subcutaneous injection, once a week for 24 to 48 weeks depending on response Ribavirin 200 mg tablets [1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects < 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food] by mouth, twice daily, for 24 to 48 weeks depending on response Telaprevir 375 mg tablets [2250 mg total daily dose: subjects should take 750 mg (two 375 mg tablets) orally three times a day, approximately 7-9 hours apart) for 12 weeks](streamdown:incomplete-link) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon Lambda-1a | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with Sustained Virologic Response at post-treatment follow-up Week 12 (SVR12) | Post treatment follow-up Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieve SVR12 in treatment-naive subjects | Post treatment follow-up Week 12 | |
| Proportion of subjects with rash related dermatologic events | Up to 12 weeks of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
Infection with Hepatitis C virus (HCV) other than Genotype-1b
Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)-1/HIV-2 antibody test at screening
Evidence of chronic liver disease caused by diseases other than chronic HCV infection
Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening
Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening
Current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Laboratory values:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Va Long Beach Healthcare System | Long Beach | California | 90822 | United States | ||
| Gastrointestinal Specialists Of Georgia Pc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27327078 | Derived | Flisiak R, Kawazoe S, Znoyko O, Assy N, Gadano A, Kao JH, Lee KS, Zwirtes R, Portsmouth S, Dong Y, Xu D, Kumada H, Srinivasan S. Peginterferon Lambda-1a/Ribavirin with Daclatasvir or Peginterferon Alfa-2a/Ribavirin with Telaprevir for Chronic Hepatitis C Genotype 1b. J Interferon Cytokine Res. 2016 Nov;36(11):635-643. doi: 10.1089/jir.2015.0173. Epub 2016 Jun 21. |
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| Peginterferon Alfa-2a |
| Biological |
|
|
| Ribavirin | Drug |
|
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| Daclatasvir | Drug |
|
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| Telaprevir | Drug |
|
|
| Proportion of subjects who develop treatment emergent cytopenic abnormalities |
Treatment emergent cytopenic abnormalities [anemia as defined by Hemoglobin (Hb) < 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) < 750/mm3, and or thrombocytopenia as defined by platelets < 50,000/mm3] |
| Up to 48 Weeks |
| Proportion of subjects with on-treatment interferon (IFN) associated flu like/musculoskeletal symptoms | Up to 48 Weeks |
| Proportion of subjects who achieve SVR24 [Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Lower limit of quantitation (LLOQ)] at post-treatment follow-up Week 24 | SVR24 = Sustained virologic response at post treatment follow-up Week 24 | Post treatment follow-up Week 24 |
| Proportion of subjects with adverse events (AEs), Serious adverse events (SAEs), dose reductions, and discontinuations due to AEs through end of follow-up | Maximum of 72 weeks |
| Proportion of subjects who achieve SVR12 with a 24-week treatment regimen | Post treatment follow-up Week 12 |
| Proportion of subjects who achieve Extended rapid virologic response (eRVR) (HCV RNA < LLOQ target not detected at Weeks 4 and 12 of treatment) | Weeks 4 and 12 of treatment |
| Patient Health Questionnaire-9 (PHQ-9) score through end of follow-up | Maximum of 72 weeks |
| Proportion of subjects with treatment emergent laboratory abnormalities by toxicity grade through End of treatment (EOT) | Maximum of 72 weeks |
| Proportion of subjects with the following on-treatment interferon-associated neuropsychiatric symptoms through EOT | Psychiatric symptoms (depression, irritability or insomnia) | Maximum of 48 weeks |
| Association of Single nucleotide polymorphism (SNPs) in Interleukin 28B (IL28B) (including rs12979860) or equilibrative nucleoside transporter 1 (ENT1) with clinical responses | For each SNP in each candidate gene, allele and genotype frequencies will be summarized by treatment regimen | Post-treatment follow-up Week 12 |
| Resistant variants associated with virologic failure through end of follow-up | Maximum of 72 weeks |
| Marietta |
| Georgia |
| 30060 |
| United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Premier Medical Group Of The Hudson Valley, Pc | Poughkeepsie | New York | 12601 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18102 | United States |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | United States |
| Texas Clinical Research Institute, Llc | Arlington | Texas | 76012 | United States |
| Medvamc | Houston | Texas | 77030 | United States |
| Local Institution | Buenos Aires | Buenos Aires | 1119 | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | 1221 | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | C1181 | Argentina |
| Local Institution | Capital Federal | Buenos Aires | C1405BCK | Argentina |
| Local Institution | Mar del Plata | Buenos Aires | B7600FZN | Argentina |
| Local Institution | Prov de Santa Fe | Santa Fe Province | 2000 | Argentina |
| Local Institution | Clichy | 92118 | France |
| Local Institution | Grenoble | 38043 | France |
| Local Institution | Villejuif | 94804 | France |
| Local Institution | Berlin | 13353 | Germany |
| Local Institution | Essen | 45122 | Germany |
| Local Institution | Hamburg | 20099 | Germany |
| Local Institution | Mannheim | 68167 | Germany |
| Local Institution | München | 81377 | Germany |
| Local Institution | Haifa | 34362 | Israel |
| Local Institution | Tel Aviv | 64239 | Israel |
| Local Institution | Tel Litwinsky | 52621 | Israel |
| Local Institution | Zafed | 13110 | Israel |
| Local Institution | Foggia | 71100 | Italy |
| Local Institution | Messina | 98125 | Italy |
| Local Institution | Modena | 41100 | Italy |
| Local Institution | Pavia | 27100 | Italy |
| Local Institution | Pisa | 56124 | Italy |
| Local Institution | Nagoya | Aichi-ken | 4678602 | Japan |
| Local Institution | Kitakyushu | Fukuoka | 8030816 | Japan |
| Local Institution | Kitakyushu-shi | Fukuoka | 8028533 | Japan |
| Local Institution | Gifu | Gifu | 5008727 | Japan |
| Local Institution | Hiroshima | Hiroshima | 7348511 | Japan |
| Local Institution | Sapporo | Hokkaido | 0600033 | Japan |
| Local Institution | Kobe | Hyōgo | 6500047 | Japan |
| Local Institution | Higashiibaraki-gun | Ibaraki | 3313193 | Japan |
| Local Institution | Kawasaki-shi | Kanagawa | 2138587 | Japan |
| Local Institution | Yokohama | Kanagawa | 2320024 | Japan |
| Local Institution | Yokohama | Kanagawa | 2458575 | Japan |
| Local Institution | Kumamoto | Kumamoto | 8628655 | Japan |
| Local Institution | Kyoto | Kyoto | 6028566 | Japan |
| Local Institution | Kyoto | Kyoto | 6128555 | Japan |
| Local Institution | Saga | Saga-ken | 8408571 | Japan |
| Local Institution | Minato-ku | Tokyo | 1058470 | Japan |
| Local Institution | Musashino-shi | Tokyo | 1808610 | Japan |
| Local Institution | Sumida-ku | Tokyo | 1308575 | Japan |
| Local Institution | Tanabe-shi | Wakayama | 6468558 | Japan |
| Local Institution | Bialystok | 15-540 | Poland |
| Local Institution | Lodz | 91-347 | Poland |
| Local Institution | Mysłowice | 41-400 | Poland |
| Local Institution | Wroclaw | 50-349 | Poland |
| Local Institution | Moscow | 111123 | Russia |
| Local Institution | Moscow | 119991 | Russia |
| Local Institution | Moscow | 119992 | Russia |
| Local Institution | Moscow | 121170 | Russia |
| Local Institution | Moscow | 125367 | Russia |
| Local Institution | Saint Petersburg | 191167 | Russia |
| Local Institution | Saint Petersburg | 196645 | Russia |
| Local Institution | Stavropol | 355017 | Russia |
| Local Institution | Busan | 614-735 | South Korea |
| Local Institution | Seoul | 110-774 | South Korea |
| Local Institution | Seoul | 135-720 | South Korea |
| Local Institution | Seoul | 138-736 | South Korea |
| Local Institution | Seoul | 143-729 | South Korea |
| Local Institution | Barcelona | 08916 | Spain |
| Local Institution | Madrid | 28029 | Spain |
| Local Institution | Santander | 39008 | Spain |
| Local Institution | Zaragoza | 50009 | Spain |
| Local Institution | Kaohsiung | Taiwan | 80756 | Taiwan |
| Local Institution | Taichung | 404 | Taiwan |
| Local Institution | Tainan | 704 | Taiwan |
| Local Institution | Taipei | 100 | Taiwan |
| Local Institution | Taipei | 112 | Taiwan |
| Local Institution | Taoyuan | 333 | Taiwan |
| Local Institution | London | Greater London | SE5 9RS | 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 |
| C486464 | telaprevir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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