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NCT03809533 · ClinicalTrials.gov registry record · Phase 2

The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients

A Phase 2 study of Hepatitis C and Kidney Transplantation, sponsored by Amit D Tevar, MD.

Active
Registry status
Phase 2
Development phase
30
Enrollment target
1
Study location

NCT03809533 is a Phase 2 study of Hepatitis C and Kidney Transplantation that is active but no longer recruiting, run by Amit D Tevar, MD. The registered enrollment target is 30 participants, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03809533, a Phase 2 study of Hepatitis C and Kidney Transplantation, is active but no longer recruiting, sponsored by Amit D Tevar, MD.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

This is an open-label, pilot trial to test the safety and efficacy of transplantation of kidneys from hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the kidney 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 Kidney Transplantation

Interventions

  • DRUG sofosbuvir/velpatasvir

Study Locations (1)

Pennsylvania

  • UPMC - Pittsburgh

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2019-05-29
Est. Completion 2026-04-01
Phase Phase 2

Sponsor

Amit D Tevar, MD

1 total trials

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What the Registry Record Tells You About NCT03809533

The ClinicalTrials.gov registry entry for NCT03809533 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (98% lower). The listed sponsor is Amit D Tevar, MD, which has 1 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.

NCT03809533 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT03809533 about?

NCT03809533 is a clinical study titled "The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients". This is an open-label, pilot trial to test the safety and efficacy of transplantation of kidneys from hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the kidney transplant waitlist. Treatment and prophylaxis wil...

What is the current status of trial NCT03809533?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2019-05-29. Estimated completion is 2026-04-01.

What conditions does trial NCT03809533 study?

This clinical trial studies the following conditions: Hepatitis C, Kidney Transplantation.

What interventions are being tested in trial NCT03809533?

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

Who is sponsoring clinical trial NCT03809533?

This trial is sponsored by Amit D Tevar, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03809533 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.