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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003468-36 | EudraCT Number |
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The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daclatasvir + Sofosbuvir | Active Comparator | Daclatasvir 60mg tablet and Sofosbuvir 400mg tablet oral dosing once daily for 8 weeks |
|
| Daclatasvir + Sofosbuvir + Ribavirin | Active Comparator | Daclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm once daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug |
| ||
| Sofosbuvir |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF) | SVR12 defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects treated with 8 weeks of DCV+SOF therapy or DCV+SOF+RBV therapy | Post Treatment Follow up Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by number of incidence of deaths, serious adverse events (SAE)s, discontinuation due to adverse events (AE)s, Grade 3/4 AEs and Grade 3/4 laboratory abnormalities observed from clinical laboratory testing | Approximately 1.5 years | |
| Antiviral activity measured by the proportion of subjects who achieve HCV RNA < lower limit of quantification (LLOQ) - at during and after treatment in each treatment arm |
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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 |
|---|---|---|---|---|---|---|
| Local Institution | Calgary | Alberta | T2N 4Z6 | Canada | ||
| Local Institution |
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| Drug |
|
| Ribavirin | Drug |
|
| Post treatment follow up Week 24 |
| Proportion of subjects with CC, CT or TT IL28B genotype who achieve SVR12 in each treatment arm | Post Treatment Follow up Week 12 |
| Edmonton |
| Alberta |
| T6G 2S2 |
| Canada |
| Local Institution | Vancouver | British Columbia | V5Z 1H2 | Canada |
| Local Institution | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Local Institution | Victoria | British Columbia | V8V 3P9 | Canada |
| Local Institution | Toronto | Ontario | M5G 2C4 | Canada |
| Local Institution | Créteil | 94010 | France |
| Local Institution | Limoges | 87042 | France |
| Local Institution | Montpellier | 34295 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Pessac | 33604 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54511 | France |
| 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 |
|---|---|
| C549273 | daclatasvir |
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
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