NCT07060638 · Samer Gawrieh
Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial
(ITAALD)
What this study is about
This is a conducted at multiple hospitals, randomly assigned, double-blinded, compared against an inactive treatment trial focused on the treatment of severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD).
View original scientific description
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.
Interventions
DRUG
IL-22
F-652 (IL-22) is a fusion protein of human IL-22 with IgG2 fragment, and has anti-inflammatory effects
DRUG
Prednisone
Prednisone is an adrenal glucocorticoid with anti-inflammatory effects
DRUG
Acamprosate
Acamprosate is a propane-1 sulfonic acid with anti-ethanol dependency effects
DRUG
Prednisone placebo
Matching placebo
DRUG
IL-22 (F-652) Placebo
Matching Placebo
BEHAVIORAL
Motivational Interviewing (MI)
MI is an evidence-based counseling style to overcome ambivalence to treatment in AUD patients
BEHAVIORAL
Motivational Enhancement Therapy (MET)
MET is an MI-based approach that includes 2-4 behavioral treatment sessions based on the Platform Treatment Manual
BEHAVIORAL
Usual Care
defined as a brief intervention with advice not to drink alcohol-containing beverages and referral to a 12-step program
Primary outcome measures
Death
Time frame: 6 months
Number (%) of participants who die from any cause
Liver transplant
Time frame: 6 months
Number (%) of participants who receive liver transplant
Ascites
Time frame: 6 months
Number (%) of participants with new onset of clinically detectable
Hepatic encephalopathy
Time frame: 6 months
Number (%) of participants with hepatic encephalopathy ≥ New Haven grade 2
Portal hypertensive bleeding
Time frame: 6 months
Number (%) of participants with gastroesophageal varices or portal gastropathy
Liver-related hospital admission
Time frame: 6 months
Number (%) of participants with liver-related hospital admission for ascites, hepatic encephalopathy, infection, GI bleeding
Increase in MELD score > 5 points
Time frame: 6 months
Number (%) of participants with increase in MELD score \> 5 points
Return to drinking
Time frame: 6 months
Number (%) of participants that return to drinking defined as \<100% abstinence-using timeline follow back questionnaire
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥18, \<70
- MELD 20-35 on day of randomization
- Definitive or probable diagnosis as defined by the NIAAA criteria
- Onset of jaundice (defined as serum total bilirubin \>3 mg/dL) within the prior 8 weeks
- Ongoing 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
- AST \> 50 IU/L,
- AST: ALT \> 1.5
- ALT and AST values \< 400 IU/L
- and/or histological evidence of AH\
- \*In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST \< 50 IU/L or \> 400 IU/L, AST/ALT ratio \< 1.5), antinuclear antibody \> 1:160 or SMA \> 1:80, a standard of care liver biopsy may be performed during current hospital admission to confirm AH and exclude competing etiologies.
- Females of child
Where
- Indianapolis, Indiana
- Louisville, Kentucky
- Rochester, Minnesota
- Cleveland, Ohio
- Dallas, Texas
- Richmond, Virginia
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations