Effect of Alpha-1 Antitrypsin Supplementation on Alcohol-Associated Hepatitis
NCT Number: NCT06582329
Acronym: EARTH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Alcohol-Associated Hepatitis
Sponsor: Medical University Innsbruck
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2026-07

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.

Primary Outcome Measures: Serum concentration of IL-6 (interleukin-6) assessed at Visit 2 (Day 8+/-1) in the intervention (A1AT in combination with standard-of-care) and control group (standard-of-care)., The effect on the serum IL-6 concentration assessed after 1 week will be assessed at Visit 2 (Day 8+/-1) in the intervention (A1AT in combination with standard-of-care) and control group (standard-of-care)., at visit 2
Secondary Outcome Measures: Serum A1AT concentration assessed at visit 5 (Day 29+/-3), at visit 5 (Day 29+/-3)|Incidence of Adverse Events (AEs) from the baseline visit (Day 1) to end of study visit (Day 90+/-7), up to 3 months|Incidence of Serious Adverse Events (SAEs) from the baseline visit (Day 1) through to end of study visit (Day 90+/-7), up to 3 months|Chronic Liver Disease Questionnaire (CLDQ) overall and subscale scores., The response of CLDQ results in 1 to 7 scales, ranging from "all the time" to "none of the time". Higher scores indicate the minimum frequency of symptoms and therefore a better HRQL, up to 3 months|CLDQ-D overall and subscale scores, The response of CLDQ results in 1 to 7 scales, ranging from "all the time" to "none of the time". Higher scores indicate the minimum frequency of symptoms and therefore a better HRQL., up to 3 months
Other Outcome Measures: Model for end-stage liver disease (MELD), The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (you are less sick) to 40 (you are gravely sick), used for liver transplant candidates, up to 3 months|The MELD-sodium (MELD-Na), MELD-Na Score adds sodium to the MELD model for liver cirrhosis. The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (you are less sick) to 40 (you are gravely sick), used for liver transplant, up to 3 months|Child-Pugh-Turcotte, The score employs five clinical measures of liver disease. Each measure is scored 1-3, with 3 indicating most severe derangement. Chronic liver disease is classified into Child-Pugh class A to C, employing the added score from above. 5-6 points class A, 79 points class B, 10-15 points class C. Class A with the best outcome, class C with the most severe., up to 3 months|CLIF (Chronic Liver Failure)-C-AD (acute decompensation), The CLIF-C acute decompensation (AD) score is used to predict prognosis of patients with acute decompensation of cirrhosis who do not have acute-on-chronic liver failure (ACLF)., up to 3 months|CLIF-C-OF (organ function), Each organ system is scored on a scale to generate the overall CLIF-C OF score, ranging from 0 to 18. A higher CLIF-C OF score translates into a higher ACLF grade., up to 3 months|CLIF-SOFA (Sequential Organ Failure Assessment) score, The CLIF-SOFA score is calculated on a scale from 0 to 4, whereas 4 means the worst outcome, up to 3 months|Maddrey's discriminant function, Prospective studies have shown that it is useful in predicting short term prognosis, especially mortality within 30 days. A value more than 32 implies poor outcome, up to 3 months|Time to hospital discharge, up to 3 months|Time to re-hospitalization, up to 3 months|Time to ICU admission, up to 3 months|Liver-specific survival and transplant-free survival at End of Study Visit, up to 3 months|Serum concentrations of IL-6, up to 3 months