A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C
- Conditions
- Chronic Hepatitis C
- Registration Number
- NCT02161939
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
University of Florida
🇺🇸Gainesville, Florida, United States
Mayo Clinic
🇺🇸Phoenix, Arizona, United States
Piedmont Transplant
🇺🇸Atlanta, Georgia, United States
USC - Keck Medical Center
🇺🇸Los Angeles, California, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
UNC
🇺🇸Chapel Hill, North Carolina, United States
Mass General
🇺🇸Boston, Massachusetts, United States
Research Specialist of Texas
🇺🇸Houston, Texas, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Mercy Medical Center, Inc.
🇺🇸Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center, University Campus
🇺🇸Worchester, Massachusetts, United States
Henry Ford
🇺🇸Detroit, Michigan, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Carolinas Healthcare Institute
🇺🇸Charlotte, North Carolina, United States
University of Pennsylvania
🇺🇸Philadephia, Pennsylvania, United States
Swedish Hospital
🇺🇸Seattle, Washington, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States