Alcohol Hepatitis
Conditions
Keywords
ADX-629
Brief summary
A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1)
Interventions
DRUGADX-629
125 mg twice daily for 28 days
Sponsors
Aldeyra Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Emergent Adverse Event Query | Day 1 to Day 28 | Incidence and severity of treatment-emergent adverse events |
Countries
United States
Outcome results
None listed