RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1)

Official Title

A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Moderate Alcohol Associated Hepatitis

Quick Facts

Study Start:2024-11-04
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06685692

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult ≥ 21 years old on the day of signing the informed consent form;
  2. * Clinical diagnosis of alcoholic hepatitis, based on clinical features and laboratory testing, confirmed by the Investigator at screening
  3. * Agreement to abstain from alcohol and utilize resources to cease at-risk behaviors during the trial, including addiction/alcohol abuse treatment
  4. * Ability and willingness to swallow tablets
  5. * Willingness to provide signed informed consent, prior to any trial-related procedures and willingness to comply with the trial procedures and requirements
  1. * Pregnant, intending to become pregnant (or father a child), or breastfeeding
  2. * Current or recent enrollment in another interventional trial in the 30 days prior to screening

Contacts and Locations

Study Contact

Bill Cavanagh Clinical Operations
CONTACT
781-257-3063
bcavanagh@aldeyra.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Aldeyra Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-04
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-11-04
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • ADX-629

Additional Relevant MeSH Terms

  • Alcoholic Hepatitis