A Clinical Trial Investigating the Safety and Efficacy of Subjects with Alcoholic Hepatitis (Part 1)
Phase 2
Recruiting
- Conditions
- Alcoholic Hepatitis
- Interventions
- Drug: ADX-629
- Registration Number
- NCT06685692
- Lead Sponsor
- Aldeyra Therapeutics, Inc.
- Brief Summary
A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Alcoholic Hepatitis (Part 1)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ADX-629 (125 mg twice daily) ADX-629 - ADX-629 (250 mg twice daily) ADX-629 -
- Primary Outcome Measures
Name Time Method Treatment-Emergent Adverse Event Query Day 1 to Day 28 Incidence and severity of treatment-emergent adverse events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Synergry Healthcare
🇺🇸Bradenton, Florida, United States