Clinical Trial

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

Study acronym: EARTH
Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated March 6, 2025 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-08-30.
Trial Details
NCT Number NCT06582329
Lead Sponsor Medical University Innsbruck
Conditions Alcohol-Associated Hepatitis
Enrollment 16 participants
Start Date 2025-04
Primary Completion 2025-07 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-03-06