Status:
COMPLETED
A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis
Lead Sponsor:
Southern California Institute for Research and Education
Collaborating Sponsors:
University of Southern California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Conditions:
Alcoholic Hepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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/predniso...
Detailed Description
This is a prospective, randomized trial of two experimental treatments, prednisolone + mycophenolate mofetil and prednisolone + rilonacept, in comparison with standard of care, in patients with alcoho...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- History of chronic alcohol consumption (defined as \>60g ethanol/day for women and \>80g ethanol/day for men) for at least the past 5 years
- Less than 8 weeks between last intake of alcohol and Screening
- Maddrey's Discriminant Function score (DF)\>32
- Willing to undergo liver biopsy for histological assessment of alcoholic hepatitis.
- Willing to provide liver tissue, whole blood, stool and ascitic fluid as part of a correlative study
- Onset of jaundice \<3 months prior to Screening
- Age greater or equal to 18 years
- Exclusion Criteria (Brief):
- Liver disease significantly caused by etiologies other than alcohol.
- Upper GI bleeding requiring transfusion within 48 hours prior to start of prednisolone (Day 1)
- Infection that has been treated with appropriate antibiotics for less than 72 hours or which has not responded appropriately to 72 hours or more of antibiotic treatment prior to start of prednisolone (Day 1)
- Clinical evidence of select active infections in the past 3 months (fungal, mycobacterial, cytomegalovirus (CMV), herpes, coccidioidomycosis, tuberculosis (TB) and human immunodeficiency virus (HIV))
- Renal insufficiency
- Laboratory exclusions
- Hemoglobin \<7g/dL
- Total Bilirubin \<7.5mg/dL
- Aspartate aminotransferase (AST) \>500 IU/mL; or AST:Alanine aminotransferase (ALT) ratio \< 1
- Pregnant or breast-feeding or unwilling to use appropriate birth control
- Other clinically significant diseases (uncontrolled diabetes, severe cardiovascular or pulmonary disease, transplant recipient, recent cancer)
- Use of oral or systemic corticosteroids for more than 7 days during the 14 days prior to Day 1 or likely use of oral or systemic corticosteroids in the first 12 weeks of the clinical trial for underlying diseases
- Use of select contraindicated medications
- Previous randomization in the trial
- Based on the investigators judgment, subject is not capable of complying with the study requirements.
Exclusion
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01903798
Start Date
December 1 2014
End Date
April 1 2016
Last Update
June 12 2025
Active Locations (3)
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1
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
2
LAC USC Medical Center
Los Angeles, California, United States, 90033
3
Harbor-UCLA Medical Center
Torrance, California, United States, 90509