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
More Details
- NCT ID
- NCT06685692
- Status
- Completed
- Sponsor
- Aldeyra Therapeutics, Inc.