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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: Recruiting Phase 2 study of Alcohol-associated Hepatitis, sponsored by Samer Gawrieh.
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number (%) of participants who die from any cause
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 |
What NCT07060638 shows while recruiting
NCT07060638 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher).
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 lists 6 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Alcohol-associated Hepatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07060638's enrollment target sits among peer trials
216 286th of 2000 higher than 1,713 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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