Overview

A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis

Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 2
Details
Lead Sponsor:
Southern California Institute for Research and Education
Timothy Morgan, MD
Collaborators:
Los Angeles Biomedical Research Institute
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Southern California Institute for Research and Education
University of Southern California
VA Long Beach Healthcare System
Treatments:
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Mycophenolate mofetil
Mycophenolic Acid
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Rilonacept