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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024637-23 | EudraCT Number |
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The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Sentinel A | Experimental | BMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily |
|
| Arm 2: Sentinel B | Experimental | BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin |
|
| Arm 3: Expansion A1 | Experimental | BMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily |
|
| Arm 4: Expansion A2 | Experimental | BMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily |
|
| Arm 5: Expansion B1 | Experimental | BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-790052 | Drug | Tablets, Oral, 60 mg, once daily, 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment | 12 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments will be based on medical review of the frequency of SAEs and AEs, discontinuations due to AEs, and abnormalities observed from vital sign and ECG measurements, physical examinations and clinical laboratory results | Serious Adverse Events (SAEs), Adverse Events (AEs), Electrocardiogram (ECG) | 12 weeks post-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 |
|---|---|---|---|---|---|---|
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States | ||
| Southern California Liver Centers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26683763 | Derived | Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24. | |
| 23504694 |
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| Arm 6: Expansion B2 | Experimental | BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin |
|
| Arm 7: Expansion B3 | Experimental | BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin |
|
| BMS-650032 | Drug | Tablets, Oral, 600 mg, twice daily, 24 weeks |
|
| BMS-650032 | Drug | Tablets, Oral, 200mg, twice daily, 24 weeks |
|
| BMS-650032 | Drug | Tablets, Oral, 200 mg, once daily, 24 weeks |
|
| Pegylated-interferon alfa-2a | Drug | Syringe, Subcutaneous Injection, 180 µg, once weekly |
|
|
| Ribavirin | Drug | Tablets, Oral For subjects weighing < 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg Twice daily (< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks |
|
|
| Pharmacokinetic parameter maximum observed concentration [Cmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. |
| Day 1 and Day 14 |
| Pharmacokinetic parameter trough observed concentration [Cmin] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. | Days 1, Days 7, Days 14, Weeks 4, Weeks 8, Weeks 12, Weeks 16 |
| Pharmacokinetic parameter time of maximum observed concentration [Tmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. | Day 1 and Day 14 |
| Pharmacokinetic parameter area under the concentration-time curve in one dosing interval [AUC(TAU)] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected. | Day 1 and Day 14 |
| Coronado |
| California |
| 92118 |
| United States |
| San Jose Gastroenterology | San Jose | California | 95128 | United States |
| University Of Colorado Denver & Hospital | Aurora | Colorado | 80045 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| University Of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Carolinas Center For Liver Disease | Statesville | North Carolina | 28677 | United States |
| Texas Clinical Research Institute, Llc | Arlington | Texas | 76012 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| Local Institution | Clichy | 92118 | France |
| Local Institution | Créteil | 94010 | France |
| Local Institution | Marseille | 13285 | France |
| Local Institution | Paris | 75571 | France |
| Local Institution | Paris | 75651 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Pessac | 33604 | France |
| Local Institution | San Juan | 00927 | Puerto Rico |
| Derived |
| McPhee F, Hernandez D, Yu F, Ueland J, Monikowski A, Carifa A, Falk P, Wang C, Fridell R, Eley T, Zhou N, Gardiner D. Resistance analysis of hepatitis C virus genotype 1 prior treatment null responders receiving daclatasvir and asunaprevir. Hepatology. 2013 Sep;58(3):902-11. doi: 10.1002/hep.26388. Epub 2013 Jul 16. |
| 22256805 | Derived | Lok AS, Gardiner DF, Lawitz E, Martorell C, Everson GT, Ghalib R, Reindollar R, Rustgi V, McPhee F, Wind-Rotolo M, Persson A, Zhu K, Dimitrova DI, Eley T, Guo T, Grasela DM, Pasquinelli C. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med. 2012 Jan 19;366(3):216-24. doi: 10.1056/NEJMoa1104430. |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C549273 | daclatasvir |
| C571889 | asunaprevir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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