A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1)
A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Moderate Alcohol Associated Hepatitis
1 other identifier
interventional
4
1 country
6
Brief Summary
A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2024
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2024
CompletedFirst Submitted
Initial submission to the registry
November 11, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2025
CompletedDecember 12, 2025
December 1, 2025
8 months
November 11, 2024
December 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment-Emergent Adverse Event Query
Incidence and severity of treatment-emergent adverse events
Day 1 to Day 28
Study Arms (2)
ADX-629 (125 mg twice daily)
EXPERIMENTALADX-629 (250 mg twice daily)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Synergry Healthcare
Bradenton, Florida, 34209, United States
Florida Health Sciences Center/Tampa General Hospital/USF
Tampa, Florida, 33606, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
UDL Clinical Research, LLC
Houston, Texas, 77057, United States
Methodist Specialty and Transplant Hospital
San Antonio, Texas, 78229, United States
Bon Secours Liver Institute of Newport News
Richmond, Virginia, 23221, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2024
First Posted
November 12, 2024
Study Start
November 4, 2024
Primary Completion
June 18, 2025
Study Completion
June 18, 2025
Last Updated
December 12, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share