AI444-257 (Daclatasvir Expanded Access)

Protocol: 
AI444257

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

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 Website: https://clinicaltrials.gov/show/NCT02161939

Are you Eligible? (Inclusion Criteria)

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

Specialty Area(s)

Trial Location

NYP/Columbia
New York, NY 10032
United States