A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis
|ClinicalTrials.gov Identifier: NCT01903798|
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : April 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Alcoholic Hepatitis||Drug: Rilonacept Drug: Mycophenolate mofetil Drug: Prednisolone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2014|
|Primary Completion Date :||April 2016|
|Study Completion Date :||April 2016|
Active Comparator: Continue Prednisolone (Lille <0.45)
Continue prednisolone 40 mg/day (current standard of care) for 21 days.
Experimental: Rilonacept + Prednisolone (Lille <0.45)
Prednisolone (40mg/day) and rilonacept (Arcalyst®) subcutaneously once a week for 21 days (320 mg on study Day 8 and 160 mg on study Day 15 and study Day 22).
Other Name: ARCALYST®Drug: Prednisolone
No Intervention: Standard of Care (Lille ≥ 0.45)
Standard of care therapy (continue prednisolone, stop all therapy and/or offer palliative care)
Experimental: Mycophenolate + Prednisolone (Lille ≥ 0.45)
Prednisolone (40 mg/day) and mycophenolate mofetil for 21 days (500 mg BID for first 4 days followed by 1000 mg BID for the next 17 days).
Drug: Mycophenolate mofetil
Other Name: CellCept®Drug: Prednisolone
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903798
|United States, California|
|VA Long Beach Healthcare System|
|Long Beach, California, United States, 90822|
|LAC USC Medical Center|
|Los Angeles, California, United States, 90033|
|Harbor-UCLA Medical Center|
|Torrance, California, United States, 90509|
|Principal Investigator:||Timothy R. Morgan, MD||VA Long Beach Healthcare System/Southern California Institute for Research and Education|