Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01968382 | Safety and Efficacy of IMM 124-E for Patients With Severe Alcoholic Hepatitis | PHASE2 | COMPLETED | 57 | — | — | Dec 1, 2014 | Dec 22, 2018 | Jan 27, 2020 | 3 | United States |
Number of events and severity of gastrointestinal events, including nausea, vomiting, and diarrhea
Number of incidents of the following: renal failure, encephalopathy or pulmonary compromise.
Number of incidents of sepsis.
Number of incidents of all other serious adverse events and other adverse events not already assessed as a primary outcome.
| Arm | Type | Description |
|---|---|---|
| IMM 124-E 2400 mg/day | EXPERIMENTAL | Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily. |
| IMM 124-E 4800 mg/day | EXPERIMENTAL | Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets. |
| Placebo (High protein milk powder) | PLACEBO_COMPARATOR | Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily. |
| Name | Type | Description |
|---|---|---|
| IMM 124-E (Hyperimmune Bovine Colostrum) | DRUG | Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E. |
| Placebo (High protein milk powder) | DRUG | Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily |
Inclusion Criteria: * Alcoholic hepatitis * Men and women age 21 and above * MELD \>= 20 but \<=28 * About to initiate prednisolone treatment, \< 7 days of steroid treatment, or treatment naive. * Actively consuming alcohol within 6 weeks of entry into the study * Willing and able to comply with st...