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

ConditionAlcohol-Associated Hepatitis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorMedical University Innsbruck

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female patient ≥18 years of age at time of consent.

Severe AAH (Maddrey's discriminant function score ≥ 32) at screening.

No ACLF or ACLF Grade 1 at screening.

Daily average intake of >80 g (men)/>60 g (women) ethanol during the past 3 months (patient reported).

Disqualifiers

Uncontrolled Diabetes Mellitus type 1 or 2 (defined by HbA1c > 10%).

Corticosteroid use contraindicated.

Viral hepatitis, autoimmune hepatitis, HIV infection, Wilson disease, hemochromatosis, toxic liver injury, Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC).

Participation in another interventional clinical study within 6 months prior to screening and/or during trial participation.

Trial design

Design model

Parallel

Treatments tested in this trial

Alfa1 Antitrypsin
Drug
Participants will be treated intravenously with A1AT 120 mg/kg bodyweight once a week for 4 weeks (4 total infusions).

Treatment groups

16 Participants

are divided into 2 treatment groups

Group A: standard of careNo intervention 0 interventions

Group B: Standard of care + Alpha 1 AntitrypsinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

at visit 2

Secondary outcomes

Serum A1AT concentration assessed at visit 5 (Day 29+/-3)

Time frame

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)

Time frame

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)

Time frame

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

Time frame

up to 3 months

Other outcomes

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

Time frame

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

Time frame

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.

Time frame

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).

Time frame

up to 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University Innsbruck

Lead sponsor

Source ClinicalTrials.gov

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