A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|