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NCT04596475 · ClinicalTrials.gov registry record · Phase 1
Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor
A Phase 1 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04596475: Completed Phase 1 study, sponsored by University of California, San Diego.
NCT04596475 is a Phase 1 study that has completed, run by University of California, San Diego. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04596475, a Phase 1 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This trial will be done in participants who undergo transplantation of heart, kidney or lung at University of California, San Diego (UCSD) and receive a hepatitis C infected donor organ. In this trial, the plan is to start hepatitis C treatment just before transplant surgery and treat for a short one-week course to see if hepatitis C infection can be prevented in the transplant recipient. The plan is to perform this trial in 10 participants and if successful, the next step is to try to make it standard of care as prevention of infection is better than treating hepatitis C after discharge from transplant surgery (which is usually a 12 week standard treatment).
Primary Outcome
The primary outcome is the percentage of patients sustained virological response (SVR) at day 91 after completion of a 7-day course of GLE/PIB.
Interventions
- DRUG glecaprevir/pibrentasvir (GLE/PIB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-05-28 |
| Est. Completion | 2022-04-21 |
| Phase | Phase 1 |
What the finished NCT04596475 record still lists
NCT04596475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which glecaprevir/pibrentasvir (GLE/PIB) is the first listed.
NCT04596475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04596475 about?
NCT04596475 is a clinical study titled "Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor". This trial will be done in participants who undergo transplantation of heart, kidney or lung at University of California, San Diego (UCSD) and receive a hepatitis C infected donor organ. In this trial, the plan is to start hepatitis C treatment just before transplant surgery and treat for a short on...
What is the current status of trial NCT04596475?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-05-28. Estimated completion is 2022-04-21.
What interventions are being tested in trial NCT04596475?
The interventions under investigation include: glecaprevir/pibrentasvir (GLE/PIB) (DRUG).
Who is sponsoring clinical trial NCT04596475?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04596475's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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