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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 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.

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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).

Conditions Studied

Hepatitis C Liver Transplant

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

Sponsor

Fernanda P Silveira, MD, MS

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03819322

The ClinicalTrials.gov registry entry for NCT03819322 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (96% lower). The listed sponsor is Fernanda P Silveira, MD, MS, which has 2 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.