CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
Mycophenolate mofetil +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01903798
NCT01903798Phase 2Completed

A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Mycophenolate Mofetil and Rilonacept (Anti-interleukin-1) in Patients With Alcoholic Hepatitis

Southern California Institute for Research and Education·interventional·Posted Jul 19, 2013·Updated Jun 12, 2025

In Brief

A Phase 2 clinical trial evaluating Mycophenolate mofetil, Prednisolone, and 1 other intervention for Alcoholic Hepatitis. Completed, enrolled 4 participants across 3 sites.

Detailed 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).

Study Details

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 19, 2013
Enrollment StartDec 1, 2014
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.0 years ago

Interventions

Mycophenolate mofetildrug

Immunosuppressive agent

Prednisolonedrug

Corticosteroid

Rilonaceptdrug