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NCT07060638 · ClinicalTrials.gov registry record · Phase 2
Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial
A Phase 2 study of Alcohol-associated Hepatitis, sponsored by Samer Gawrieh.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 216
- Enrollment target
- 6
- Study locations
NCT07060638 is a Phase 2 study of Alcohol-associated Hepatitis that is actively recruiting participants, run by Samer Gawrieh. The registered enrollment target is 216 participants. The trial reports 6 study locations across 6 states.
The verdict
NCT07060638, a Phase 2 study of Alcohol-associated Hepatitis, is actively recruiting participants, sponsored by Samer Gawrieh.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 216 participants
- Enrollment target
- 6
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Prednisone
- DRUG IL-22
- DRUG Acamprosate
- DRUG Prednisone placebo
- DRUG IL-22 (F-652) Placebo
Study Locations (6)
Indiana
- Indiana University - Indianapolis
Kentucky
- University of Louisville - Louisville
Minnesota
- Mayo Clinic - Rochester
Ohio
- Cleveland Clinic - Cleveland
Texas
- University of Texas Southwestern Medical School - Dallas
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2026-01-27 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07060638
The ClinicalTrials.gov registry entry for NCT07060638 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Samer Gawrieh, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alcohol-associated Hepatitis appearing as the primary indexed condition, and to 5 interventions - of which Prednisone is the first listed.
NCT07060638 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Indiana, Kentucky, Minnesota.
Frequently Asked Questions
What is clinical trial NCT07060638 about?
NCT07060638 is a clinical study titled "Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) 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 wil...
What is the current status of trial NCT07060638?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 216 participants. The study started on 2026-01-27. Estimated completion is 2029-12.
What conditions does trial NCT07060638 study?
This clinical trial studies the following conditions: Alcohol-associated Hepatitis.
What interventions are being tested in trial NCT07060638?
The interventions under investigation include: Prednisone (DRUG), IL-22 (DRUG), Acamprosate (DRUG), Prednisone placebo (DRUG), IL-22 (F-652) Placebo (DRUG).
Who is sponsoring clinical trial NCT07060638?
This trial is sponsored by Samer Gawrieh, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07060638 being conducted?
This trial has 6 study locations across Indiana, Kentucky, Minnesota, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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