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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: Active Phase 2 study of Hepatitis C and Heart Transplant, sponsored by Mary E. Keebler, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Rate of adverse events due to sofosbuvir/velpatasvir (Epclusa) in patients in each experimental group
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 |
What the registry record for NCT03222531 still lists
NCT03222531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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 NCT03222531's enrollment target sits among peer trials
20 94th of 106 higher than 9 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
-
The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients
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-
The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients
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-
Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C
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-
A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
COMPLETED · Phase 2
-
Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
COMPLETED · Phase 2
-
A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects
COMPLETED · Phase 2
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