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

Aldeyra Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Alcohol Hepatitis

Treatments: Drug: ADX-629

Study type: Interventional

Funder types: Industry

Identifiers

NCT06685692

ADX-629-ALH-001

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

ADX-629 (125 mg twice daily)

Experimental group

Treatment:

Drug: ADX-629

Drug: ADX-629

ADX-629 (250 mg twice daily)

Experimental group

Treatment:

Drug: ADX-629

Drug: ADX-629