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NCT03382847 · ClinicalTrials.gov registry record · Phase 4
HCV Positive Heart Donors
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
NCT03382847 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 25 participants.
The verdict
NCT03382847, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
Study Summary
Study subjects active on the waiting list for a heart transplant at the NYU Langone Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from a donor who tests positive for HCV. The study will entail surveillance for the development of HCV viremia post-transplant. Patients who develop HCV viremia post-transplant will be treated with an FDA-approved, pan-genotypic direct acting antiviral drug, Mavyret. Patients who are treated with Mavyret will be monitored for clearance of viremia and for sustained virologic response.
Interventions
- COMBINATION_PRODUCT Transplant with HCV positive donor, followed by surveillance and treatment of viremia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-01-05 |
| Est. Completion | 2020-05-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03382847
The ClinicalTrials.gov registry entry for NCT03382847 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Transplant with HCV positive donor, followed by surveillance and treatment of viremia is the first listed.
NCT03382847 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03382847 about?
NCT03382847 is a clinical study titled "HCV Positive Heart Donors". Study subjects active on the waiting list for a heart transplant at the NYU Langone Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from a donor who tests positive for HCV. The study will entail surveillance for the development of HCV viremia post-transplant. ...
What is the current status of trial NCT03382847?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2018-01-05. Estimated completion is 2020-05-06.
What interventions are being tested in trial NCT03382847?
The interventions under investigation include: Transplant with HCV positive donor, followed by surveillance and treatment of viremia (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03382847?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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