drugset / Trial / NCT06582329

Effect of Alpha-1 Antitrypsin Supplementation on Alcohol-Associated Hepatitis

NCT06582329

Phase 2 Not yet recruiting 16 enrolled Medical University Innsbruck
RandomizedParallel-groupOpen-labelTreatment

Summary

The trial is designed as a prospective, single center, open label, randomized controlled pilot study evaluating the effect of A1AT (Alpha 1 Antitrypsin) on inflammation in patients with severe AAH (alcohol-associated hepatitis). The objective is to evaluate the safety and the effect of intravenous A1AT on the systemic inflammation in patients with severe AAH. The objectives also include the assessment of A1AT on clinical outcomes including the incidence of adverse events (AEs) and serious adverse events (SAEs) and the cytokine.

Timeline

Start
2025-04
Primary completion
2025-07
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpha 1-Antitrypsin Protein / enzyme biologic 120 mg/kg Intravenous

Indications