Phase 2
N=4
A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis
Alcoholic Hepatitis
Bottom Line
View on ClinicalTrials.gov: NCT01903798 ↗Enrolled (actual)
4
Serious AEs
50.0%
Results posted
Oct 2018
Primary outcome: Primary: Survival at Day 29 of the Assigned Treatment — 2; 0; 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mycophenolate mofetil (Drug); Prednisolone (Drug); Rilonacept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Southern California Institute for Research and Education
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival at Day 29 of the Assigned Treatment |
2; 0; 1; 1 | — |
| SECONDARY Number of Patients Reported Ascites |
0; 0; 1; 0 | — |
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).
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT01903798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.