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Mycophenolate mofetil · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Mycophenolate mofetil | DRUG | Immunosuppressive agent |
| Prednisolone | DRUG | Corticosteroid |
| Rilonacept | DRUG | - |
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 li...
Mycophenolate mofetil is being studied as a treatment for Alcoholic Hepatitis, a condition of liver inflammation caused by heavy alcohol use. It is currently in Phase 2 clinical development for this indication. The drug is being evaluated for safety and efficacy in patients with this condition.
Mycophenolate mofetil is a small molecule that works by inhibiting inosine monophosphate dehydrogenase, an enzyme involved in the synthesis of guanine nucleotides. This action suppresses the proliferation of T and B lymphocytes, thereby reducing the immune response that contributes to liver inflammation in Alcoholic Hepatitis.
Mycophenolate mofetil is being developed by National Healthcare Corp. (ticker: NHC). The company is conducting clinical research on this drug for the treatment of Alcoholic Hepatitis.
Mycophenolate mofetil is in Phase 2 clinical development for Alcoholic Hepatitis. It is an investigational drug and has not been approved by regulatory authorities for this indication. One Phase 2 trial has been completed.
Mycophenolate mofetil has been studied in one clinical trial, NCT01903798, titled 'A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis.' This Phase 2 trial was completed in the United States and enrolled 4 participants.
Mycophenolate mofetil is the generic name for the drug also known as CellCept. In the context of this research, it is being investigated for Alcoholic Hepatitis, a different indication from its established uses in organ transplantation.