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

Overview

About this study

The primary objective of this program is to provide Daclatasvir (DCV) for 24 weeks to be given in combination with Sofosbuvir (SOF) to post-liver transplant subjects with chronic hepatitis C recurrence and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to < 12 months, including advanced fibrosis or fibrosing cholestatic hepatitis.This protocol will be opened at specific clinical sites for the treatment of individual subjects for whom there are no other treatment options and will allow for the collection of safety and efficacy data.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Hugo Vargas, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

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Supplemental Study Information

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CLS-20133368

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