Chronic Hepatitis C Clinical Trial
Official title:
A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Subjects With Chronic Hepatitis C and Decompensated Cirrhosis or Post-Liver Transplant Subjects With Chronic Hepatitis C Recurrence
| NCT number | NCT02161939 |
| Other study ID # | AI444-257 |
| Secondary ID | |
| Status | No longer available |
| Phase | N/A |
| First received | June 10, 2014 |
| Last updated | January 28, 2016 |
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
| Status | No longer available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com Inclusion Criteria: - Patients chronically infected with Hepatitis C - Subjects who received a liver transplant, have chronic hepatitis C virus (HCV) recurrence and advanced fibrosis (Metavir F3-F4) or fibrosing cholestatic hepatitis - Subjects with decompensated cirrhosis defined by Child-Pugh Class C Exclusion Criteria: - Patients who are <18 years old - Clinical or pathologic evidence of acute ongoing liver graft rejection - Creatinine clearance (CrCl) =30 mL/min (as estimated by Cockcroft and Gault formula) - Patients who have contraindications to either Daclatasvir (DCV) or Sofosbuvir (SOF) - Patients who are pregnant or Women of Child Bearing Potential who are not using required contraception |
N/A
| Country | Name | City | State |
|---|---|---|---|
| United States | Piedmont Transplant | Atlanta | Georgia |
| United States | Mercy Medical Center, Inc. | Baltimore | Maryland |
| United States | Mass General | Boston | Massachusetts |
| United States | Montefiore Medical Center | Bronx | New York |
| United States | UNC | Chapel Hill | North Carolina |
| United States | Carolinas Healthcare Institute | Charlotte | North Carolina |
| United States | Henry Ford | Detroit | Michigan |
| United States | University of Florida | Gainesville | Florida |
| United States | Research Specialist of Texas | Houston | Texas |
| United States | Indiana University | Indianapolis | Indiana |
| United States | USC - Keck Medical Center | Los Angeles | California |
| United States | Yale University School of Medicine | New Haven | Connecticut |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Columbia University Medical Center | New York | New York |
| United States | Weill Cornell Medical College | New York | New York |
| United States | University of Pennsylvania | Philadephia | Pennsylvania |
| United States | Mayo Clinic | Phoenix | Arizona |
| United States | Virginia Commonwealth University | Richmond | Virginia |
| United States | Swedish Hospital | Seattle | Washington |
| United States | University of Massachusetts Memorial Medical Center, University Campus | Worchester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
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