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Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial

ConditionAlcohol-associated Hepatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSamer Gawrieh

About this trial

This is a multicenter, randomized, double-blinded, placebo-controlled trial focused on the treatment of severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD).

The primary purpose of the study is to determine whether subjects receiving sAH therapy in addition to AUD treatments will have better alcohol and liver-related outcomes at 6 months compared to sAH therapy plus usual care for AUD. Patients assigned to the AUD treatment will receive Acamprosate and counseling whereas those assigned to AUD standard care will receive brief advice and referral to a 12-step program.

The secondary purpose of the study is to determine if F-652 is safe and effective in treating sAH when compared to prednisone. Subjects will receive F-652 on days 1 and 7 or prednisone for 28 days. Outcomes will be measured by overall survival at 90 days.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18, <70

MELD 20-35

Definitive or probable diagnosis of sAH as defined by the NIAAA criteria4, 5 A. Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks B. Ongoing average consumption of > 40 gm (for females) and > 60 gm (for males) alcohol daily for 6 months or more with less than 8 weeks of abstinence before onset of jaundice; OR If, in the investigator's judgment, alcohol use may have been underreported, available clinical evidence-including collateral history, medical records, prior documentation of alcohol use, alcohol biomarkers such as PEth, or other relevant evidence-indicates that the participant met the protocol-defined alcohol consumption requirement within the 8 weeks before screening.

Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening.

Disqualifiers

Active listing for liver transplantation before screening

MELD score <20 or > 35

Uncontrolled infection (persistent positive blood or other body fluid cultures despite 48 hours of antibiotic therapy)

Progressive hemodynamic compromise requiring intravenous pressors

Trial design

Design model

Sequential

Treatments tested in this trial

  • IL-22

    Drug

    F-652 (IL-22) is a fusion protein of human IL-22 with IgG2 fragment, and has anti-inflammatory effects

  • Prednisone

    Drug

    Prednisone is an adrenal glucocorticoid with anti-inflammatory effects

  • Acamprosate

    Drug

    Acamprosate is a propane-1 sulfonic acid with anti-ethanol dependency effects

  • Prednisone placebo

    Drug

    Matching placebo

  • IL-22 (F-652) Placebo

    Drug

    Matching Placebo

  • Motivational Interviewing (MI)

    Behavioral

    MI is an evidence-based counseling style to overcome ambivalence to treatment in AUD patients

  • Motivational Enhancement Therapy (MET)

    Behavioral

    MET is an MI-based approach that includes 2-4 behavioral treatment sessions based on the Platform Treatment Manual

  • Usual Care

    Behavioral

    defined as a brief intervention with advice not to drink alcohol-containing beverages and referral to a 12-step program

Treatment groups

216 Participants
are divided into 4 treatment groups
Group A: IL-22 (F-652), Prednisone Placebo, Acamprosate, MI and METActive comparator 5 interventions
Group B: IL-22 (F-652), Prednisone Placebo, and usual careActive comparator 3 interventions
Group C: Prednisone, IL-22 (F-652) Placebo, Acamprosate, MI, and METActive comparator 5 interventions
Group D: Prednisone, IL-22 (F-652) Placebo, and usual careActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Death

Number (%) of participants who die from any cause

Time frame
6 months
2

Liver transplant

Number (%) of participants who receive liver transplant

Time frame
6 months
3

Ascites

Number (%) of participants with new onset of clinically detectable

Time frame
6 months
4

Hepatic encephalopathy

Number (%) of participants with hepatic encephalopathy ≥ New Haven grade 2

Time frame
6 months

Secondary outcomes

1

Transplant-free survival

Time participants live without liver transplant

Time frame
30 days, 90 days, 180 days, 1 year, and 2 years
2

Overall Survival

Time participants live

Time frame
30 days, 90 days, 180 days, 1 year, and 2 years

Other outcomes

1

Change in MELD Score

Increase or decrease in MELD score. MELD is Model for End-stage Liver Disease Model. Higher MELD is associated with worse outcomes while lower MELD is associated with better outcomes. MELD typically ranges from 6-40.

Time frame
30, 90, 180 days
2

Acute kidney injury (AKI)

Number (%) of participants with AKI

Time frame
30, 90, 180 days
3

Multi-organ failure

Number (%) of participants with multi-organ failure

Time frame
30, 90, 180 days
4

Transfer to ICU

Number (%) of participants with transfer to ICU

Time frame
30, 90, 180 days

Sponsors and contacts

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

Samer Gawrieh

Lead sponsor

Indiana University

Sponsor institution

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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