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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 is a Phase 2 study that has completed, run by Southern California Institute for Research and Education. The registered enrollment target is 4 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01903798
The ClinicalTrials.gov registry entry for NCT01903798 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Southern California Institute for Research and Education, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Prednisolone is the first listed.
NCT01903798 reports 0 study locations.
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.
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