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Not recruiting
Phase 2

Alcohol Associated Hepatitis

Sponsor:

Aldeyra Therapeutics, Inc.

Code:

NCT06685692

Conditions

Alcohol Hepatitis

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

ADX-629

ADX-629

Study Details

Brief summary:

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

Conditions

Alcohol Hepatitis

Study ID

NCT06685692

Start date

Nov 4, 2024

Status verified date

Jan, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ADX-629 (125 mg twice daily)

experimental: ADX-629 (250 mg twice daily)

Interventions

ADX-629

125 mg twice daily for 28 days

ADX-629

250 mg twice daily for 28 days

Primary outcome measure

  • Treatment-Emergent Adverse Event Query [ Time Frame: Day 1 to Day 28 ]

Central Contacts and Locations

Central contacts

Bill Cavanagh Clinical Operations

781-257-3063bcavanagh@aldeyra.com

Locations

Synergry Healthcare

Recruiting

Bradenton, Florida, United States, 34209

Contacts

Patrick S. Weston, MD

941-896-4948pweston@synergyhealthcorp.com

Florida Health Sciences Center/Tampa General Hospital/USF

Recruiting

Tampa, Florida, United States, 33606

Contacts

Nyingi Kemmer, MD

813-844-9302nkemmer@tgmg.org

The Liver Institute at Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

Contacts

Parvez Mantry, MD

214-947-4450Parvezmantry@mhd.com

UDL Clinical Research, LLC

Recruiting

Houston, Texas, United States, 77057

Contacts

Chinyere Awa, MD

248-707-0519obilarry463@gmail.com

Methodist Specialty and Transplant Hospital

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Omer Junaidi, MD

210-575-1060Omer.Junaidi@hcahealthcare.com

Bon Secours Liver Institute of Newport News

Recruiting

Richmond, Virginia, United States, 23221

Contacts

Mitchell Shiffman, MD

804-977-8920Mitchell_Shiffman@bshsi.org

More Information

Sponsor

Aldeyra Therapeutics, Inc.

Last update posted

Jan 29, 2025

Last verified

Jan, 2025

Keywords

  • ADX-629

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Aldeyra Therapeutics, Inc. on 2025-01-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.