Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial
Public ClinicalTrials.gov record NCT07060638. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07060638
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 216 participants
Conditions and interventions
Conditions
Interventions
- IL-22 Drug
- Prednisone Drug
- Acamprosate Drug
- Prednisone placebo Drug
- IL-22 (F-652) Placebo Drug
- Motivational Interviewing (MI) Behavioral
- Motivational Enhancement Therapy (MET) Behavioral
- Usual Care Behavioral
Drug · Behavioral
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 26, 2026
- Primary completion
- Nov 30, 2029
- Completion
- Nov 30, 2029
- Last update posted
- Jul 14, 2026
2026 – 2029
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | Recruiting |
| University of Louisville | Louisville | Kentucky | 40292 | Recruiting |
| Mayo Clinic | Rochester | Minnesota | 55902 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| University of Texas Southwestern Medical School | Dallas | Texas | 15260 | Recruiting |
| Virginia Commonwealth University | Richmond | Virginia | 23284 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07060638, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07060638 live on ClinicalTrials.gov.