A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C
1 other identifier
expanded_access
N/A
1 country
20
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
20 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
June 12, 2014
CompletedJanuary 29, 2016
January 1, 2016
June 10, 2014
January 28, 2016
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Mayo Clinic
Phoenix, Arizona, 85054, United States
USC - Keck Medical Center
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2014
First Posted
June 12, 2014
Last Updated
January 29, 2016
Record last verified: 2016-01