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NCT03249194 · ClinicalTrials.gov registry record · Early Phase 1
Hepatitis C Virus Donor Positive Kidney Transplantation for Hepatitis C Virus Negative Recipients
A Early Phase 1 study, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 25
- Enrollment target
NCT03249194 is a Early Phase 1 study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 25 participants.
The verdict
NCT03249194, a Early Phase 1 study, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The development of direct acting anti-virals (DAAs) for the treatment of Hepatitis C virus (HCV) has changed the landscape of HCV therapy dramatically in the last several years with reported sustained virologic response (SVR) rates in excess of 95% for treatment-naïve HCV positive patients including those who have received liver or kidney transplants. Since these new regimens do not include interferon and have already been studied in the post-liver and kidney transplant setting, they now offer a unique opportunity to expand the donor pool and improve the lives of those awaiting renal transplant. The address this gap in knowledge, the investigators hypothesize that pre-emptive treatment with a direct acting anti-viral HCV medication to cure HCV soon after transplant would allow for safe transplantation of HCV positive kidneys in disadvantaged and needy HCV negative kidney recipients with acceptable risks and improved survivals compared with historical cohorts.
Interventions
- DRUG Direct acting Anti-Viral Therapy using Epclusa or Zepatier
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2017-08-17 |
| Est. Completion | 2020-03-15 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03249194
The ClinicalTrials.gov registry entry for NCT03249194 describes a study currently listed as completed, categorized as Early Phase 1. 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 Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Direct acting Anti-Viral Therapy using Epclusa or Zepatier is the first listed.
NCT03249194 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03249194 about?
NCT03249194 is a clinical study titled "Hepatitis C Virus Donor Positive Kidney Transplantation for Hepatitis C Virus Negative Recipients". The development of direct acting anti-virals (DAAs) for the treatment of Hepatitis C virus (HCV) has changed the landscape of HCV therapy dramatically in the last several years with reported sustained virologic response (SVR) rates in excess of 95% for treatment-naïve HCV positive patients including...
What is the current status of trial NCT03249194?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 25 participants. The study started on 2017-08-17. Estimated completion is 2020-03-15.
What interventions are being tested in trial NCT03249194?
The interventions under investigation include: Direct acting Anti-Viral Therapy using Epclusa or Zepatier (DRUG).
Who is sponsoring clinical trial NCT03249194?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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