The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients (NCT03819322) | Clinical Trial Compass
CompletedPhase 2
The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients
United States5 participantsStarted 2019-08-15
Plain-language summary
This is an open-label, pilot trial to test the safety and efficacy of transplantation of livers from Hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the liver transplant waitlist. Treatment and prophylaxis will be administered, using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with end-stage liver disease listed for liver transplantation at UPMC.
✓. Age ≥ 18
✓. No available living liver donor
✓. Listed for an isolated liver transplant at UPMC
✓. Have panel reactive antibody level of \<98%
✓. Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation
✓. Able to provide informed consent
✓. Be willing to use a contraceptive method for a year after transplant
Exclusion criteria
✕. HIV positive
✕. HCVAb or HCV RNA positive
✕. Presence of behavioral risk factors for contracting HCV. These behavioral risk factors are current injection drug use, current intranasal illicit drug use, current percutaneous/parenteral exposures in an unregulated setting.
✕. Hepatitis B surface antigen positive
✕. History of atrial fibrillation requiring the use of amiodarone over the past 12m
✕. Receipt of prior organ transplant
What they're measuring
1
Adverse Events Due to Sofosbuvir/Velpatasvir (Epclusa)