Table 3.
Ongoing clinical trials in patients with moderate alcoholic hepatitis.
| NCT identifier | Treatment | Mechanism | Study design | Definition of moderate AH | Primary endpoint |
|---|---|---|---|---|---|
| 03157388 | Combination of vancomycin, gentamycin and meropenem in oral formulation | Microbiome modulation | Open-label. Single-arm treatment | All spectrum of AH, potentially including patients with moderate disease. Not severity cutoff specified. | Evaluate the effect of gut sterilisation on macrophage activation (Difference in serum levels of macrophage activation markers sCD163) |
| 01922895 | Lactobacillus rhamnosus GG versus placebo | Microbiome modulation | Double-blind, randomised controlled trial with parallel assignment | MELD < 20 | Evolution of MELD score at 30 days |
| 02655510 | IL-22 (F-652) | Hepatocyte regeneration | Open-label. Single-arm treatment. Dose escalating study | All spectrum of AH. Includes a subgroup of patients with MELD 11–20 |
Safety and tolerability |
| 02039219 | Obeticholic acid versus placebo | Amelioration of bile-acid injury | Double-blind, randomised controlled trial with parallel assignment | MELD > 11 and < 20 | Evolution of MELD score at 6 weeks along with safety and tolerability |
| 03432260 | DUR-928 | Small molecule. Epigenetic modulator regulating multiple biological pathways involved in metabolic homeostasis, inflammatory response, cell survival and tissue regeneration. | Open-label. Single-arm treatment. Dose escalating study | All spectrum of AH. MELD 11–30, inclusive |
Safety and tolerability |