A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1)
Purpose
A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1)
Condition
- Alcohol Hepatitis
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adult ≥ 21 years old on the day of signing the informed consent form; - Clinical diagnosis of alcoholic hepatitis, based on clinical features and laboratory testing, confirmed by the Investigator at screening - Agreement to abstain from alcohol and utilize resources to cease at-risk behaviors during the trial, including addiction/alcohol abuse treatment - Ability and willingness to swallow tablets - Willingness to provide signed informed consent, prior to any trial-related procedures and willingness to comply with the trial procedures and requirements
Exclusion Criteria
- Pregnant, intending to become pregnant (or father a child), or breastfeeding - Current or recent enrollment in another interventional trial in the 30 days prior to screening
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ADX-629 (125 mg twice daily) |
|
|
|
Experimental ADX-629 (250 mg twice daily) |
|
Recruiting Locations
Synergry Healthcare
Bradenton, Florida 34209
Bradenton, Florida 34209
Florida Health Sciences Center/Tampa General Hospital/USF
Tampa, Florida 33606
Tampa, Florida 33606
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas 75203
Dallas, Texas 75203
UDL Clinical Research, LLC
Houston, Texas 77057
Houston, Texas 77057
Methodist Specialty and Transplant Hospital
San Antonio, Texas 78229
San Antonio, Texas 78229
Bon Secours Liver Institute of Newport News
Richmond, Virginia 23221
Richmond, Virginia 23221
More Details
- NCT ID
- NCT06685692
- Status
- Recruiting
- Sponsor
- Aldeyra Therapeutics, Inc.