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NCT03819322 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Hepatitis C and Liver Transplant, sponsored by Fernanda P Silveira, MD, MS.

Completed
Registry status
Phase 2
Development phase
73
Enrollment target
1
Study location

NCT03819322: Completed Phase 2 study of Hepatitis C and Liver Transplant, sponsored by Fernanda P Silveira, MD, MS.

NCT03819322 is a Phase 2 study of Hepatitis C and Liver Transplant that has completed, run by Fernanda P Silveira, MD, MS. The registered enrollment target is 73 participants, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03819322, a Phase 2 study of Hepatitis C and Liver Transplant, has completed, sponsored by Fernanda P Silveira, MD, MS.

COMPLETED
Registry status
Phase 2
Development phase
73 participants
Enrollment target
1
Study location

Study 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).

Primary Outcome

Adverse events due to sofosbuvir/velpatasvir (Epclusa)

Interventions

  • DRUG sofosbuvir/velpatasvir

Study Locations (1)

Pennsylvania

  • UPMC - Pittsburgh

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2019-08-15
Est. Completion 2025-03-17
Phase Phase 2
Fernanda P Silveira, MD, MS

2 total trials

What the finished NCT03819322 record still lists

NCT03819322 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (96% lower).

The record links to 2 conditions, with Hepatitis C appearing as the primary indexed condition, and to 1 intervention - of which sofosbuvir/velpatasvir is the first listed.

NCT03819322 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT03819322 about?

NCT03819322 is a clinical study titled "The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients". 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 ...

What is the current status of trial NCT03819322?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2019-08-15. Estimated completion is 2025-03-17.

What conditions does trial NCT03819322 study?

This clinical trial studies the following conditions: Hepatitis C, Liver Transplant.

What interventions are being tested in trial NCT03819322?

The interventions under investigation include: sofosbuvir/velpatasvir (DRUG).

Who is sponsoring clinical trial NCT03819322?

This trial is sponsored by Fernanda P Silveira, MD, MS, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03819322 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Hepatitis C

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03819322's enrollment target sits among peer trials

73 63rd of 106 higher than 44 of 106 other Hepatitis C trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatitis C trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03819322, the US trial registry maintained by the National Library of Medicine. NCT03819322 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.