Alcoholic HepatitisPhase 2NCT01903798
A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis
A Phase 2 study testing Mycophenolate mofetil, Prednisolone and Rilonacept in people with Alcoholic Hepatitis, run by Southern California Institute for Research and Education at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- Mycophenolate mofetil, Prednisolone and Rilonacept
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2014to Apr 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Long Beach Healthcare System
Long Beach, California, 90822
LAC USC Medical Center
Los Angeles, California, 90033
Harbor-UCLA Medical Center
Torrance, California, 90509
About this study
Official title: 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
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).
Read the 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 alcoholic hepatitis. Patients will start therapy with prednisolone. At Day 8 response to prednisolone will be determined using the Lille score. Patients with a Lille score ≥ 0.45 will be randomized to standard of care (continue prednisolone, stop all therapy and/or offer palliative care) or to have prednisolone continued and mycophenolate added for the next three weeks. Patients with a Lille score <0.45 will be randomized to continue prednisolone alone (standard of care) or to have rilonacept added to their treatment regimen (experimental group) for the next three weeks. Patients will complete follow-up visits at Week 12 and Week 24.
- Conditions
- Alcoholic Hepatitis
- Being tested
- Mycophenolate mofetil, Prednisolone, Rilonacept
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunosuppressive agent
PrednisoloneDrug
Corticosteroid
RilonaceptDrug
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone (Lille <0.45) | Active comparator | At Day 8, after randomization, this participants will continue prednisolone 40 mg/day (current standard of care) for 21 days. Receives: Drug: Prednisolone |
| Prednisolone, rilonacept (Lille <0.45) | Experimental | This group will continue Prednisolone (40mg/day). Additionally, they will receive rilonacept (Arcalyst®) once a week for 21 days. After randomization at Day 8, study participants will be given 320 mg subcutaneously (two injections of 2.0 ml, 160 mg each). On Day 15 and Day 22, study participants will be given 160 mg subcutaneously (one injection of 160 mg). Receives: Drug: Prednisolone; Drug: Rilonacept |
| Prednisolone (Lille >0.45) | Active comparator | Prednisolone (40 mg/day) for the first 7 days, after randomization at Day 8, they will stop all therapy. Receives: Drug: Prednisolone |
| Prednisolone, mycophenolate(Lille > 0.45) | Experimental | This group will continue Prednisolone (40mg/day). Additionally, they will receive mycophenolate mofetil (CellCept®) for a total of 21 days. After randomization at Day 8, they will receive CellCept® at a dose of 1000 mg per day for the first four days followed by 2000 mg per day (two 500 mg tablets bid) for the remaining 17 days. Receives: Drug: Mycophenolate mofetil; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at Day 29 of the Assigned Treatment
To determine whether treatment with prednisolone + mycophenolate mofetil is better than standard of care treatment among patients with alcoholic hepatitis who fail to respond to 1 week of prednisolone (i.e., Lille score of ≥0.45). Primary outcome is survival at Day 29.
All study participants received the Standard of care (prednisolone) with or without experimental drug at Day 1 (based on randomization). Response to the treatment was determined at Day 8. Data was collected for both responders and non-responders.
Measured: Day 8 to Day 29
Secondary outcomes (1)
Number of Patients Reported Ascites
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startDec 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, VA Long Beach Healthcare System, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Timothy Morgan, MD, Southern California Institute for Research and Education
- Investigators
- Timothy R. Morgan, MD, Principal investigator, VA Long Beach Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903798
- Sponsor's protocol ID
- SCAHC Clinical Trial
- Other IDs
- 1U01AA021886
- Status last verified
- May 2025
- First submitted
- 16 Jul 2013
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01903798
- Acronym / sponsor ID
- SCAHC Clinical Trial
- Conditions
- Alcoholic Hepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Southern California Institute for Research and EducationUniversity, hospital or other
- Collaborators
- University of Southern California, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, VA Long Beach Healthcare System, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Dec 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Posted 25 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 alcoholic hepatitis. Patients will start therapy with prednisolone. At Day 8 response to prednisolone will be determined using the Lille score. Patients with a Lille score ≥ 0.45 will be randomized to standard of care (continue prednisolone, stop all therapy and/or offer palliative care) or to have prednisolone continued and mycophenolate added for the next three weeks. Patients with a Lille score <0.45 will be randomized to continue prednisolone alone (standard of care) or to have rilonacept added to their treatment regimen (experimental group) for the next three weeks. Patients will complete follow-up visits at Week 12 and Week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prednisolone (Lille <0.45) | Active comparator | Drug: PrednisoloneAt Day 8, after randomization, this participants will continue prednisolone 40 mg/day (current standard of care) for 21 days. |
| Prednisolone, rilonacept (Lille <0.45) | Experimental | Drug: Prednisolone, Drug: RilonaceptThis group will continue Prednisolone (40mg/day). Additionally, they will receive rilonacept (Arcalyst®) once a week for 21 days. After randomization at Day 8, study participants will be given 320 mg subcutaneously (two injections of 2.0 ml, 160 mg each). On Day 15 and Day 22, study participants will be given 160 mg subcutaneously (one injection of 160 mg). |
| Prednisolone (Lille >0.45) | Active comparator | Drug: PrednisolonePrednisolone (40 mg/day) for the first 7 days, after randomization at Day 8, they will stop all therapy. |
| Prednisolone, mycophenolate(Lille > 0.45) | Experimental | Drug: Mycophenolate mofetil, Drug: PrednisoloneThis group will continue Prednisolone (40mg/day). Additionally, they will receive mycophenolate mofetil (CellCept®) for a total of 21 days. After randomization at Day 8, they will receive CellCept® at a dose of 1000 mg per day for the first four days followed by 2000 mg per day (two 500 mg tablets bid) for the remaining 17 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycophenolate mofetilImmunosuppressive agent | Drug | Prednisolone, mycophenolate(Lille > 0.45) |
| PrednisoloneCorticosteroid | Drug | Prednisolone (Lille <0.45), Prednisolone (Lille >0.45), Prednisolone, mycophenolate(Lille > 0.45), Prednisolone, rilonacept (Lille <0.45) |
| Rilonacept | Drug | Prednisolone, rilonacept (Lille <0.45) |
Primary outcome
Survival at Day 29 of the Assigned Treatment
Time frame: Day 8 to Day 29
To determine whether treatment with prednisolone + mycophenolate mofetil is better than standard of care treatment among patients with alcoholic hepatitis who fail to respond to 1 week of prednisolone (i.e., Lille score of ≥0.45). Primary outcome is survival at Day 29. All study participants received the Standard of care (prednisolone) with or without experimental drug at Day 1 (based on randomization). Response to the treatment was determined at Day 8. Data was collected for both responders and non-responders.
1 secondary outcome
Number of Patients Reported Ascites
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy R. Morgan, MD principal investigator
VA Long Beach Healthcare System
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mycophenolate mofetil, Prednisolone and Rilonacept in people with Alcoholic Hepatitis, run by Southern California Institute for Research and Education at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at Day 29 of the Assigned Treatment (time frame: Day 8 to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.