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

Bristol-Myers Squibb (BMS)

Status

Conditions: Chronic Hepatitis C

Treatments: Drug: Daclatasvir (BMS-790052); Drug: Sofosbuvir

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02161939

AI444-257

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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