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The primary objective of this program is to provide DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C recurrence with either advanced fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to <12 months, therefore, no research hypothesis will be tested and no specific endpoints are defined. However, safety data will be collected throughout the study as well as efficacy data
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir (BMS-790052) | Drug | |||
| Sofosbuvir | Drug |
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 | Phoenix | Arizona | 85054 | United States | ||
| USC - Keck Medical Center |
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| Label | URL |
|---|---|
| EAP Investigator Requests | View source |
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| Los Angeles |
| California |
| 90033 |
| United States |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Piedmont Transplant | Atlanta | Georgia | 30309 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Mercy Medical Center, Inc. | Baltimore | Maryland | 21202 | United States |
| Mass General | Boston | Massachusetts | 02114 | United States |
| University of Massachusetts Memorial Medical Center, University Campus | Worchester | Massachusetts | 01655 | United States |
| Henry Ford | Detroit | Michigan | 48202 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| UNC | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Healthcare Institute | Charlotte | North Carolina | 28204 | United States |
| University of Pennsylvania | Philadephia | Pennsylvania | 19104 | United States |
| Research Specialist of Texas | Houston | Texas | 77030 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Swedish Hospital | Seattle | Washington | 98122 | United States |
| 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 |
| D000069474 | Sofosbuvir |
| 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 |
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