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NCT01903798 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis
A Phase 2 study, sponsored by Southern California Institute for Research and Education.
- Completed
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT01903798: Completed Phase 2 study, sponsored by Southern California Institute for Research and Education.
NCT01903798 is a Phase 2 study that has completed, run by Southern California Institute for Research and Education. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01903798, a Phase 2 study, has completed, sponsored by Southern California Institute for Research and Education.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
This clinical trial will test two new therapies for the treatment of alcoholic hepatitis. Patients who "respond" to the current standard of care therapy for alcoholic hepatitis(corticosteroid/prednisolone therapy) after 1 week of treatment will be randomly assigned to either continue on standard therapy, or, to begin treatment with rilonacept in combination with standard therapy. Patients who are "non-responders" to the current standard of care therapy after 1 week of treatment will be randomly assigned to standard of care or to begin treatment with mycophenolate mofetil in combination with standard therapy. Patients will be treated for a total of 4 weeks in this clinical trial. Patients will be followed for up to five months after completing therapy (6 months total).
Primary Outcome
To determine whether treatment with prednisolone + mycophenolate mofetil is better than standard of care treatment among patients with alcoholic hepatitis who fail to respond to 1 week of prednisolone (i.e., Lille score of ≥0.45). Primary outcome is survival at Day 29. All study participants received the Standard of care (prednisolone) with or without experimental drug at Day 1 (based on randomization). Response to the treatment was determined at Day 8. Data was collected for both responders an
Interventions
- DRUG Prednisolone
- DRUG Mycophenolate mofetil
- DRUG Rilonacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-12 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
What the finished NCT01903798 record still lists
NCT01903798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Prednisolone is the first listed.
NCT01903798 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01903798 about?
NCT01903798 is a clinical study titled "A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis". This clinical trial will test two new therapies for the treatment of alcoholic hepatitis. Patients who "respond" to the current standard of care therapy for alcoholic hepatitis(corticosteroid/prednisolone therapy) after 1 week of treatment will be randomly assigned to either continue on standard the...
What is the current status of trial NCT01903798?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2014-12. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01903798?
The interventions under investigation include: Prednisolone (DRUG), Mycophenolate mofetil (DRUG), Rilonacept (DRUG).
Who is sponsoring clinical trial NCT01903798?
This trial is sponsored by Southern California Institute for Research and Education, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01903798's enrollment target sits among peer trials
4 2001st of 2000 the lowest 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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