Investigating a new treatment for alcohol-related hepatitis
A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Moderate Alcohol Associated Hepatitis
This study is testing a new medication called ADX-629 to see if it can help adults with alcohol-related hepatitis improve their liver function and overall health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Aldeyra Therapeutics, Inc. Industry-sponsored |
| Locations | 6 sites (Bradenton, Florida and 5 other locations) |
| Trial ID | NCT06685692 on ClinicalTrials.gov |
What this trial studies
This clinical trial is focused on evaluating the safety and efficacy of a medication called ADX-629 in adults diagnosed with moderate alcohol-associated hepatitis. Participants will be required to abstain from alcohol and engage in treatment for at-risk behaviors during the trial. The study aims to assess how well ADX-629 can improve liver function and overall health in these patients. The trial is part of a Phase 2 investigation, indicating that it is exploring the effectiveness of the treatment after initial safety has been established.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 and older with a clinical diagnosis of moderate alcohol-associated hepatitis.
Not a fit: Patients who are pregnant, breastfeeding, or currently enrolled in another interventional trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from alcohol-associated hepatitis.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in treating liver conditions with novel therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bradenton, Florida and 5 other locations
- Synergry Healthcare — Bradenton, Florida, United States (Recruiting)
- Florida Health Sciences Center/Tampa General Hospital/USF — Tampa, Florida, United States (Recruiting)
- The Liver Institute at Methodist Dallas Medical Center — Dallas, Texas, United States (Recruiting)
- UDL Clinical Research, LLC — Houston, Texas, United States (Recruiting)
- Methodist Specialty and Transplant Hospital — San Antonio, Texas, United States (Recruiting)
- Bon Secours Liver Institute of Newport News — Richmond, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Bill Cavanagh Clinical Operations
- Email: bcavanagh@aldeyra.com
- Phone: 781-257-3063
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.