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NCT03383419 · ClinicalTrials.gov registry record · Phase 2
Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
A Phase 2 study of Heart Failure, sponsored by Baylor Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 3
- Study locations
NCT03383419: Recruiting Phase 2 study of Heart Failure, sponsored by Baylor Research Institute.
NCT03383419 is a Phase 2 study of Heart Failure that is actively recruiting participants, run by Baylor Research Institute. The registered enrollment target is 15 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03383419, a Phase 2 study of Heart Failure, is actively recruiting participants, sponsored by Baylor Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II, multi-center, open-label study will evaluate the safety and efficacy of utilizing HCV-positive donors for heart transplant in HCV-negative recipients treated with sofosbuvir 400 mg / velpatasvir 100 mg (Epclusa®).
Primary Outcome
To evaluate the number of patients with sustained virologic response (SVR) 12 weeks after discontinuation of therapy.
Conditions Studied
Interventions
- DRUG Epclusa
Study Locations (3)
California
- Cedars-Sinai Medical Center - Los Angeles
North Carolina
- Duke University Medical Center - Durham
Texas
- Baylor University Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-03-20 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 2 |
What NCT03383419 shows while recruiting
NCT03383419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Epclusa is the first listed.
NCT03383419 reports a single indexed study location in California, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT03383419 about?
NCT03383419 is a clinical study titled "Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients". This phase II, multi-center, open-label study will evaluate the safety and efficacy of utilizing HCV-positive donors for heart transplant in HCV-negative recipients treated with sofosbuvir 400 mg / velpatasvir 100 mg (Epclusa®).
What is the current status of trial NCT03383419?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2018-03-20. Estimated completion is 2026-12-30.
What conditions does trial NCT03383419 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT03383419?
The interventions under investigation include: Epclusa (DRUG).
Who is sponsoring clinical trial NCT03383419?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03383419 being conducted?
This trial has 3 study locations across California, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
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 NCT03383419's enrollment target sits among peer trials
15 372nd of 397 higher than 22 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure 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
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