Early Treatment With Sofosbuvir (SOF) and Ledipasvir (LDV) to Prevent HCV Recurrence After Liver Transplantation (OLT)

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a single centre, single arm, open-label, proof of concept study enrolling 20 adult primary liver transplant recipients with genotype 1 HCV infection. Subjects will receive Sofosbuvir (SOF) and Ledipasvir (LDV) starting at time of liver transplantation (OLT) and continues for 12 weeks. Subjects will be receive 24 week post-treatment follow up.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Ledipasvir; Sofosbuvir

Criteria

Inclusion Criteria:

• Recipient of a first (primary) live or deceased (after brain or cardiac death) donor liver transplant

• Willing and able to provide written informed consent

• Male or Female, age 18-70 years old

• Medical MELD score ≤30 at time of transplant (calculated based on serum bilirubin, creatinine and INR, i.e. not taking exception points into account)

• Quantifiable HCV RNA at time of listing or transplant evaluation

• HCV genotype 1a or 1b infection

• Female patients must have a negative pregnancy test at enrolment

Exclusion Criteria:

• Liver re-transplantation

• Recipients of multiple solid organ transplants

• Estimated GFR <30ml/min at time of transplant

• Participants transplanted for fulminant hepatic failure

• Participants co-infected with HBV or HIV

• Previous treatment with a Sofosbuvir or Ledipasvir containing regimen

• Participation in an interventional clinical trial within 1 month prior to enrolment

• Known allergies or hypersensitivity to Sofosbuvir or Ledipasvir

• Pregnancy and/or lactation