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NCT03222531 · ClinicalTrials.gov registry record · Phase 2
Expanding the Pool in Orthotopic Heart Transplantation
A Phase 2 study of Hepatitis C and Heart Transplant, sponsored by Mary E. Keebler, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03222531 is a Phase 2 study of Hepatitis C and Heart Transplant that is active but no longer recruiting, run by Mary E. Keebler, MD. The registered enrollment target is 20 participants, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03222531, a Phase 2 study of Hepatitis C and Heart Transplant, is active but no longer recruiting, sponsored by Mary E. Keebler, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, pilot trial to test the safety and efficacy of transplantation of hearts from HCV seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the heart 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
Interventions
- DRUG sofosbuvir/velpatasvir
Study Locations (1)
Pennsylvania
- UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03222531
The ClinicalTrials.gov registry entry for NCT03222531 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 20 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 (99% lower). The listed sponsor is Mary E. Keebler, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Hepatitis C appearing as the primary indexed condition, and to 1 intervention - of which sofosbuvir/velpatasvir is the first listed.
NCT03222531 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03222531 about?
NCT03222531 is a clinical study titled "Expanding the Pool in Orthotopic Heart Transplantation". This is an open-label, pilot trial to test the safety and efficacy of transplantation of hearts from HCV seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the heart transplant waitlist. Treatment and prophylaxis will be admin...
What is the current status of trial NCT03222531?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2017-08-01. Estimated completion is 2026-05-31.
What conditions does trial NCT03222531 study?
This clinical trial studies the following conditions: Hepatitis C, Heart Transplant, Cardiac Transplant.
What interventions are being tested in trial NCT03222531?
The interventions under investigation include: sofosbuvir/velpatasvir (DRUG).
Who is sponsoring clinical trial NCT03222531?
This trial is sponsored by Mary E. Keebler, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03222531 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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Related
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