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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Alcohol

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/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 Summary: 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.
Sponsor: Timothy Morgan, MD

Current Primary Outcome:

• Survival [ 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.
• Change in Bilirubin [ Time Frame: Day 8 to Day 29 ]
  To determine whether treatment with prednisolone and rilonacept (Arcalyst®) (anti-interleukin-1 [IL-1]) is better than treatment with prednisolone (standard of care) among patients with alcoholic hepatitis who respond to 1 week of prednisolone (i.e., Lille score of <0.45). Primary outcome is change in bilirubin between Day 8 (start of treatment) and Day 29 (end of treatment).

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Safety [ Time Frame: Week 24 ]
  To determine adverse events, especially infection and renal failure, for each treatment group.
• MELD and DF Score [ Time Frame: Day 8 to Day 29 ]
  To determine the change in MELD score and in Maddrey's discriminant function between Day 8 and Day 29 for each treatment group.

Original Secondary Outcome: Same as current

Information By: Southern California Institute for Research and Education

Dates:
Date Received: July 16, 2013
Date Started: December 2014
Date Completion:
Last Updated: April 15, 2016
Last Verified: April 2016