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NCT03304626 · ClinicalTrials.gov registry record · Phase 2
Budesonide for Liver Transplant Immune Suppression
A Phase 2 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT03304626: Completed Phase 2 study, sponsored by University of Cincinnati.
NCT03304626 is a Phase 2 study that has completed, run by University of Cincinnati. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03304626, a Phase 2 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a pilot study that investigates the efficacy and safety of budesonide as an immune suppressing agent for liver transplant recipients in the early post-transplant period. The primary end-point is rates of acute cellular rejection within first 24 weeks post-liver transplant. Secondary end points include rates of new onset diabetes after transplant and safety of budesonide. The study is structured as a prospective clinical trial. After receiving 4 days of intravenous corticosteroids on liver transplant post-operative days 0 through 3, subjects will be started on standard immunosuppression plus enteric coated budesonide (study drug) in place of standard immune suppression plus prednisone (standard of care). Study drug will be tapered over 12 weeks in accordance with the existing standard of care immune suppression protocol. Subjects will be followed in outpatient transplant clinic for 24 weeks. The purpose of the study is to conduct a pilot study to generate rates and effect size that can be used in a subsequent equivalent trial. A total of 20 subjects will be enrolled to receive the standard immunosuppression plus budesonide and their outcomes will be compared to 20 controls receiving standard immunosuppression plus prednisone (standard of care). The use of controls is to generate rate and variability that can be compared with the rate obtained from patients that receive study drug by examining the 95% confidence band.
Primary Outcome
Acute Cellular Rejection of liver graft was determined by liver biopsy using Banff criteria. The decision to perform liver biopsy was as per treating physician based on patient's clinical course and blood chemisteries. Protocol bioopsies were not performed.
Interventions
- DRUG Budesonide 3Mg Capsule
- DRUG Standard of Care Prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-06-27 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 2 |
What the finished NCT03304626 record still lists
NCT03304626 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Budesonide 3Mg Capsule is the first listed.
NCT03304626 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03304626 about?
NCT03304626 is a clinical study titled "Budesonide for Liver Transplant Immune Suppression". This is a pilot study that investigates the efficacy and safety of budesonide as an immune suppressing agent for liver transplant recipients in the early post-transplant period. The primary end-point is rates of acute cellular rejection within first 24 weeks post-liver transplant. Secondary end poi...
What is the current status of trial NCT03304626?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2017-06-27. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT03304626?
The interventions under investigation include: Budesonide 3Mg Capsule (DRUG), Standard of Care Prednisone (DRUG).
Who is sponsoring clinical trial NCT03304626?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03304626's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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