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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022568-11 | EudraCT Number |
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The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.
Study Classification: Pharmacokinetics/ Pharmacodynamics
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1: pegIFNλ+BMS-790052+Placebo for BMS-650032+Ribavirin | Experimental | Part A |
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| A2: pegIFNλ+BMS-650032+Placebo for BMS-790052+Ribavirin | Experimental | Part A |
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| A3: pegIFNα-2a+PBO for BMS-790052+PBO for BMS-650032+RBV | Active Comparator | Part A |
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| A4: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (24 weeks) | Experimental | Part B |
|
| A5: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (16 weeks) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Interferon Lambda (pegIFNλ) | Biological | Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (as measured by the frequency of serious adverse events (SAEs), dose reductions and discontinuations due to adverse events (AEs) | Up to end of treatment ( maximum of 48 weeks) plus 30 days | |
| Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with 24-week sustained virologic response (SVR24) | At end of treatment (maximum of 48 weeks) | |
| Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with 24-week sustained virologic response (SVR24) | Post-treatment Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of HCV genotype 1 subjects with Protocol definition of virologic response (PDR) for Part A and Part B |
| Weeks 4, Weeks 12 and post-treatment Weeks 24 |
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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 Hospital | Phoenix | Arizona | 85054 | United States | ||
| Desert Medical Group Inc. |
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| Experimental |
Part B |
|
| A6: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (24 weeks) | Experimental | Part B |
|
| A7: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (16 weeks) | Experimental | Part B |
|
|
| BMS-790052 (NS5A Inhibitor) | Drug | Tablets, Oral, 60 mg, Once daily, 24 weeks |
|
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| Ribavirin (RBV) | Drug | Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks |
|
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| BMS-650032 (NS3 Protease Inhibitor) | Drug | Tablets, Oral, 200 mg, Twice daily, 24 weeks |
|
|
| Pegylated Interferon Alfa-2a (pegIFNα-2a) | Biological | Solution, Subcutaneous, 180 μg/mL, Once weekly, 48 weeks |
|
|
| Pegylated Interferon Lambda (pegIFNλ) | Biological | Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks |
|
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| Ribavirin (RBV) | Drug | Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 weeks |
|
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| Pegylated Interferon Lambda (pegIFNλ) | Biological | Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks |
|
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| Ribavirin (RBV) | Drug | Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 16 weeks |
|
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| BMS-790052 (NS5A Inhibitor) | Drug | Tablets, Oral, 60 mg, Once daily, 16 weeks |
|
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| BMS-650032 (NS3 Protease Inhibitor) | Drug | Tablets, Oral, 200 mg, Twice daily, 16 weeks |
|
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| Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor) | Drug | Tablets, Oral, 0 mg, Twice daily, 24 weeks |
|
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| Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor) | Drug | Tablets, Oral, 0 mg, Once daily, 24 weeks |
|
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| Placebo for Ribavirin (RBV) | Drug | Tablets, Oral, 0 mg, Twice daily, 24 weeks |
|
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| Placebo for Ribavirin (RBV) | Drug | Tablets, Oral, 0 mg, Twice daily, 16 weeks |
|
|
| Proportion of subjects with either a 2-log or greater decrease in Hepatitis C virus (HCV) Ribonucleic acid (RNA) levels from baseline or undetectable levels of HCV RNA | Weeks 2, Weeks 4 and Weeks 12 |
| Proportion of subjects with viral breakthrough, defined as confirmed > 1 log10 increase in HCV RNA over nadir or confirmed HCV RNA ≥ Lower limit of quantitation (LLOQ) after confirmed undetectable HCV RNA while on treatment | Post-treatment Week 48 |
| Proportion of subjects with undetectable HCV RNA at the end of treatment that develop detectable levels of HCV RNA in the post-treatment follow-up period | Post-treatment Week 48 |
| Serum HCV Ribonucleic acid (RNA) levels over time | Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment) |
| Proportion of subjects with undetectable HCV RNA over time | Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment) |
| Time to viral clearance, defined as an absence of detectable HCV RNA | Day 1, 3, Week 1, 2, 4, 6, 8, 12, 24, 36, end of treatment (Week 48), Post-Treatment at Week 4, 12, 24, 36, 48, and 56 |
| Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Maximum observed serum/plasma concentration (Cmax) | Cmax will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a) |
| Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Time to maximum concentration (Tmax) | Tmax will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a) |
| Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Minimal observed serum/plasma concentration (Cmin) | Cmin will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a) |
| Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Area under the serum/plasma concentration-time curve during one dose interval AUC(TAU) | AUC(TAU) will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a) |
| Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In all subjects, trough concentrations will be assessed (Ctrough) | Troughs at baseline (week 0), weeks 2, 4, 8, 12, 16, and 24 |
| Proportion of subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA | At end of treatment (maximum of 48 weeks) and follow-up Week 12 |
| Proportion of subjects with 4-week sustained virologic response (SVR4), defined as undetectable HCV RNA | At end of treatment (maximum of 48 weeks) and follow-up Week 4 |
| Palm Springs |
| California |
| 92262 |
| United States |
| University Of Colorado Denver And Hospital | Aurora | Colorado | 80045 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06510 | United States |
| Johns Hopkins University | Lutherville | Maryland | 21093 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Bristol-Myers Squibb/David E. Bernstein, Md | Manhasset | New York | 11030 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Carolinas Center For Liver Disease | Statesville | North Carolina | 28677 | United States |
| St. Luke'S Episcopal Hospital - Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Local Institution | Adelaide | South Australia | 5000 | Australia |
| Local Institution | Clayton Vic | Victoria | 3168 | Australia |
| Local Institution | Heidelberg | Victoria | 3084 | Australia |
| Local Institution | Perth | Western Australia | 6001 | Australia |
| Local Institution | Clichy | 92118 | France |
| Local Institution | Créteil | 94000 | France |
| Local Institution | Montpellier | 34295 | France |
| Local Institution | Nice | 06202 | France |
| Local Institution | Paris | 75571 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Essen | 45122 | Germany |
| Local Institution | Frankfurt | 60590 | Germany |
| Local Institution | Hamburg | 20246 | Germany |
| Local Institution | Pisa | 56124 | Italy |
| Local Institution | Roma | 00161 | Italy |
| Local Institution | Hiroshima | Hiroshima | 7348511 | Japan |
| Local Institution | Sapporo | Hokkaido | 060-0033 | Japan |
| Local Institution | Kawasaki-shi | Kanagawa | 2138587 | Japan |
| Local Institution | Osaka | Osaka | 5458586 | Japan |
| Local Institution | Iruma-gun | Saitama | 3500495 | Japan |
| Local Institution | Minato-ku | Tokyo | 105-0001 | Japan |
| Local Institution | Musashino-shi | Tokyo | 180-0023 | Japan |
| Local Institution | Grafton | Auckland | 1010 | New Zealand |
| Local Institution | Christchurch | 8011 | New Zealand |
| Fundacion De Investigacion De Diego | San Juan | 00927 | Puerto Rico |
| Local Institution | Barcelona | Barcelona | 08003 | Spain |
| Local Institution | Valencia | 46010 | Spain |
| 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 |
| C549273 | daclatasvir |
| D012254 | Ribavirin |
| C571889 | asunaprevir |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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