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Anti-inflammatory
ADX-629 for Alcoholic Hepatitis
Bradenton, FL
Phase 2
Recruiting
Research Sponsored by Aldeyra Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of alcoholic hepatitis, confirmed by the Investigator at screening
Adult ≥ 21 years old on the day of signing the informed consent form
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 28
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called ADX-629 to see if it is safe and effective for treating people with alcoholic hepatitis.
See full description
Who is the study for?
This clinical trial is for individuals with alcoholic hepatitis, a condition where the liver is inflamed due to excessive alcohol intake. Specific details about who can join are not provided, but typically participants must meet certain health standards and may need to have a particular severity of disease.Check my eligibility
What is being tested?
The trial is testing ADX-629, which is likely a new treatment or medication. The study aims to determine how safe it is for patients and how effective it might be in treating alcoholic hepatitis. This part of the trial (Part 1) suggests there may be multiple phases.See study design
What are the potential side effects?
Specific side effects of ADX-629 are not listed here, but common side effects in trials like this could include gastrointestinal issues, headaches, fatigue, allergic reactions or other drug-specific reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with alcoholic hepatitis.
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Select...
I am 21 years old or older.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Treatment-Emergent Adverse Event Query
Side effects data
From 2022 Phase 2 trial • 8 Patients • NCT0472871113%
Decreased appetite
13%
Insomnia
13%
Cough
13%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
ADX-629
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: ADX-629 (250 mg twice daily)Experimental Treatment1 Intervention
Group II: ADX-629 (125 mg twice daily)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADX-629
2021
Completed Phase 2
~110
Find a Location
Closest Location:Bon Secours Liver Institute of Newport News· Richmond, VA· 343 miles
Who is running the clinical trial?
Aldeyra Therapeutics, Inc.Lead Sponsor
33 Previous Clinical Trials
4,686 Total Patients Enrolled