MedTrace Logo

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

NCT01903798 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-06-12

Study results available
· View outcomes & findings →

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).

Conditions

  • Alcoholic Hepatitis

Interventions

DRUG

Mycophenolate mofetil

Immunosuppressive agent

DRUG

Prednisolone

Corticosteroid

DRUG

Rilonacept

Sponsors & Collaborators

  • University of Southern California

    collaborator OTHER

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    collaborator OTHER

  • VA Long Beach Healthcare System

    collaborator FED

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Southern California Institute for Research and Education

    lead OTHER

Principal Investigators

  • Timothy R. Morgan, MD · VA Long Beach Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01903798 on ClinicalTrials.gov