A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C

NO_LONGER_AVAILABLE

Conditions studied: Chronic Hepatitis C

In brief

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

Key facts

Study ID

NCT02161939

Run by

Bristol-Myers Squibb

Last updated by the study team

2016-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States
• USC - Keck Medical Center — Los Angeles, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Piedmont Transplant — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Mercy Medical Center, Inc. — Baltimore, Maryland, United States
• Mass General — Boston, Massachusetts, United States
• University of Massachusetts Memorial Medical Center, University Campus — Worchester, Massachusetts, United States
• Henry Ford — Detroit, Michigan, United States
• Weill Cornell Medical College — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• UNC — Chapel Hill, North Carolina, United States
• Carolinas Healthcare Institute — Charlotte, North Carolina, United States
• University of Pennsylvania — Philadephia, Pennsylvania, United States
• Research Specialist of Texas — Houston, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Swedish Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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