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
Description
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
Phase
N/AInclusion and Exclusion 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
- 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
Sites
Please contact Valentina Rodina to learn more about where you can participate in this trial. Please use the contact form on the right side.
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