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The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients

NCT03819322 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-04-30

Study results available
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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).

Conditions

  • Liver Transplant
  • Hepatitis C

Interventions

DRUG

sofosbuvir/velpatasvir

12 week, oral, fixed dose

Sponsors & Collaborators

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • Fernanda P Silveira, MD, MS

    lead OTHER

Principal Investigators

  • Fernanda Silviera, MD · University of Pittsburgh

  • Naudia Jonassaint, MD · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2025-03-17
Completion
2025-03-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03819322 on ClinicalTrials.gov