Health Trials

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

Qualifiers

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

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

Treatments tested in this trial

  • IL-22
  • Prednisone
  • Acamprosate
  • Prednisone placebo
  • IL-22 (F-652) Placebo
  • Motivational Interviewing (MI)
  • Motivational Enhancement Therapy (MET)
  • Usual Care

Treatment groups

216 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Samer Gawrieh

Lead sponsor

Indiana University

Sponsor institution

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov