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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013652-69 | Registry Identifier | EUDRACT |
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The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2a: Arm 1 | Experimental |
| |
| Phase 2a: Arm 2 | Placebo Comparator |
| |
| Phase 2b: Arm 1 | Experimental |
| |
| Phase 2b: Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-650032 | Drug | Tablets, Oral, 200 mg, Twice Daily, 48 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs | 12 weeks after first dose | |
| Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA | Week 4 | |
| Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA | Week 12 | |
| Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA | at follow-up Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4 | Week 4 | |
| Proportion of HCV genotype 1 subjects with complete early rapid virologic response (eEVR), defined as undetectable HCV RNA at Week 12 (Stage 2 only) |
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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 |
|---|---|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35294-0006 | United States | ||
| Alabama Liver & Digestive Specialists (Alds) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25038486 | Derived | Bronowicki JP, Ratziu V, Gadano A, Thuluvath PJ, Bessone F, Martorell CT, Pol S, Terg R, Younes Z, He B, Eley T, Cohen D, Yu F, Hernandez D, McPhee F, Mendez P, Hughes E. Randomized trial of asunaprevir plus peginterferon alfa and ribavirin for previously untreated genotype 1 or 4 chronic hepatitis C. J Hepatol. 2014 Dec;61(6):1220-7. doi: 10.1016/j.jhep.2014.07.011. Epub 2014 Jul 16. |
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| BMS-650032 |
| Drug |
Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response |
|
| Placebo | Drug | Tablets, Oral, 0 mg, twice daily, 48 weeks |
|
|
| Placebo | Drug | Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12 |
|
| Placebo | Drug | Tablets, Oral, 0 mg, twice daily 24 weeks |
|
| Peginterferon Alfa-2a | Drug | Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks |
|
|
| Peginterferon Alfa-2a | Drug | Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response |
|
|
| Ribavirin | Drug | Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks |
|
|
| Ribavirin | Drug | Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response |
|
|
| at Week 12 (Stage 2 only) |
| Proportion of HCV genotype 1 subjects with early virologic response (EVR) defined as ≥2 log10 decrease in HCV RNA from baseline at Week 12 (Stage 1 only) | Week 12 (Stage 1 only) |
| Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12 | follow-up Week 12 |
| Proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24) defined as undetectable HCV RNA at follow-up Week 24 (Stage 1 only) | follow-up Week 24 (Stage 1 only) |
| Resistant variants associated with virologic failure | 48 weeks after last dose |
| Montgomery |
| Alabama |
| 36116 |
| United States |
| Florida Hospital Transplant Center | Orlando | Florida | 32804 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| The Research Institute | Springfield | Massachusetts | 01105 | United States |
| Umass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| James J Peters Vamc | The Bronx | New York | 10468 | United States |
| University Of North Carolina, Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135-2920 | United States |
| Oregon Health Science Univ | Portland | Oregon | 97239 | United States |
| Hospital Of The University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| Dean Clinic | Madison | Wisconsin | 53715 | United States |
| Local Institution | Buenos Aires | Buenos Aires | C1181 | Argentina |
| Local Institution | Ciudad de Buenos Aires | Buenos Aires | C1121ABE | Argentina |
| Local Institution | Prov. Buenos Aires | Buenos Aires | 1629 | Argentina |
| Local Institution | Prov de Santa Fe | Santa Fe Province | 2000 | Argentina |
| Local Institution | Créteil | 94010 | France |
| Local Institution | Marseille | 13285 | France |
| Local Instituition | Montpellier | 34295 | France |
| Local Institution | Paris | 75651 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution | Frankfurt | 60590 | Germany |
| Local Institution | Heidelberg | 69120 | Germany |
| Local Institution | Mainz | 55131 | Germany |
| Local Institution | Würzburg | 97080 | Germany |
| Local Institution | Dublin | Dublin | DUBLIN 7 | Ireland |
| Local Institution | Torino | 10126 | Italy |
| Local Institution | Alicante | 03010 | Spain |
| Local Institution | Barcelona | 08035 | Spain |
| Local Institution | Madrid | 28222 | Spain |
| Local Institution | Málaga | 29010 | Spain |
| Local Institution | Valencia | 46010 | Spain |
| Local Institution | London | Greater London | E1 2AT | United Kingdom |
| Local Institution | London | Greater London | SE5 9RS | United Kingdom |
| Local Institution | London | Greater London | W2 1NY | United Kingdom |
| Local Institution | Manchester | Greater Manchester | M8 5RB | United Kingdom |
| Local Institution | Glasgow | Lanarkshire | 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 |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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