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

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Sofosbuvir

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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