Table 3. Current clinical trials with novel therapeutic agents for treatment of alcoholic hepatitis (AH).
| Pharmaceutical agent | Mechanism of action | Study design [N] | Main inclusion | Primary end point | Status |
|---|---|---|---|---|---|
| Bovine colostrum (IMM-124E) | IgG antibody to LPS | PLB controlled RCT [56] | MELD 20-28 | ↓ serum endotoxin levels at 7 months | Phase-2 completed |
| Lactobacillus rhamnosus GG | Probiotic, restores gut microbiome | PLB controlled RCT [130] | MELD score <21 | Change in MELD score at 30 days | Phase-2, completed |
| Augmentin | Antibiotic amoxicillin plus clavulanic acid | PLB controlled RCT with CS [280] | MELD score ≥21 | Patient survival at 2 months | Phase-3, active and recruiting |
| Fecal matter transplantation (FMT) | Change in gut microbiome | RCT FMT vs. CS [130] | Eligible for CS treatment | Patient survival at 3 months | Active and recruiting |
| Anakinra | Antagonist to IL-1 receptor | RCT Anakinra + Zn + PTX vs. CS [103] | MELD score ≥20 and Madre DF ≥32 | Patient survival at 6 months | Phase-2, completed. Data published |
| Obeticholic acid (INT-747) | FXR receptor agonism | PLB controlled RCT [19] | MELD score >11 and <20 | Change in MELD score at 6 weeks | Phase-2, completed |
| Selonsertib (GS-4997) | ASK-1 antagonist to inhibit MAPK, JNK p38 | PLB controlled RCT with CS [99] | Maddrey DF score ≥32 | Safety and SAE at 28 days plus 30 days | Phase-2, completed. Data published |
| Metadoxine | Antioxidant and promotes abstinence | PLB controlled RCT with CS [135] | Severe alcoholic hepatitis | Patient survival at 30 days | Phase-4, completed. Data published |
| IL-22 (F-652) | Hepatic regeneration | Open label [24] | MELD score 11-28 | Safety and SAE at 42 days | Phase-1 completed; Phase-2 planned |
| G-CSF (filgrastim) | Increase neutrophils, hepatic regeneration | PLB controlled RCT (with CS in partial response and no CS in null response) [268] | Maddrey DF score ≥32 | Patient survival at 2 months in null responder and at 6 months in partial responder | Phase-4, active and recruiting |
IL, interleukin; G-CSF, granulocyte colony stimulating factor; FXR, farnesoid X receptor; PLB, placebo; RCT, randomized controlled trial; CS, corticosteroids; MELD, model for end stage disease; SAE, serious adverse events.