Liver Failure
Conditions
Keywords
HCV
Brief summary
To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV sero-negative liver recipients who are currently listed.
Interventions
PROCEDURELiver Transplantation
A HCV negative or previously successfully treated recipient with a HCV positive liver graft
Sponsors
Loma Linda University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female * Age 18 and older * Active on the transplant list * Donor organ with Antibody and nucleic acid test (NAT) positive for HCV * Graft with F2 fibrosis or less at time of explant * HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy. * Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject
Exclusion criteria
* Participants co-infected with HIV * Donor previously treated with a non-structural protein 5A (NS5a) containing regimen (if treatment history of donor known) * Known allergies or hypersensitivity to direct acting antiviral drug (DAA) or ribavirin (RBV) * Pregnancy and/or actively breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient survival rate | From the date of transplant through the last day of 15 month post transplant | Will track all subjects post transplant for 15 months |
Countries
United States
Outcome results
None listed