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

Study acronym: EARTH
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later Jul 2025 → Dec 2026
See other at-risk trials from Medical University Innsbruck

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 2025 to Dec 2026 Show 6 more changesShow less
    • Recruitment opened
    • Primary endpoints: details revised at 1 of 1 entry
    • Start date changed from estimate of Apr 2025 to Jun 18, 2025
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised
  2. Start date: Jan 2025 to Apr 2025
    • Study completion date: Jul 2026 to Dec 2026
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06582329
Lead Sponsor Medical University Innsbruck
Conditions
(from sponsor)		 Alcohol-Associated Hepatitis
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov