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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-06-18

Brief Summary

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

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Detailed Description

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Conditions

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Alcohol Hepatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADX-629 (125 mg twice daily)

Group Type EXPERIMENTAL

ADX-629

Intervention Type DRUG

125 mg twice daily for 28 days

ADX-629 (250 mg twice daily)

Group Type EXPERIMENTAL

ADX-629

Intervention Type DRUG

250 mg twice daily for 28 days

Interventions

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ADX-629

125 mg twice daily for 28 days

Intervention Type DRUG

ADX-629

250 mg twice daily for 28 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No