A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1)

Launched by ALDEYRA THERAPEUTICS, INC. · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called ADX-629 for people with alcoholic hepatitis, a serious liver condition caused by heavy drinking. The goal of the study is to find out if this treatment is safe and effective for patients. The trial is currently recruiting participants who are at least 21 years old and have been diagnosed with alcoholic hepatitis. To take part, participants must agree to stop drinking alcohol and commit to following treatment programs for any alcohol-related issues. They also need to be able to take tablets and provide consent to participate in the study.

If you or someone you know is considering joining this trial, it’s important to know that participants will be monitored closely throughout the study. They will undergo various tests, and support will be provided to help them stay alcohol-free during the trial period. This research is crucial as it aims to find better treatments for a condition that can significantly impact health and quality of life.

Gender

ALL

Eligibility 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