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Acamprosate Safety in Alcohol-related Liver Disease
NCT04287920Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2020
- Primary completion
- Jan 2022
- Countries
- 1
- Sponsor
- Mayo Clinic
- Modality
- Small Molecules
- Drugs
- acamprosate
- Conditions
- alcohol use disorder (AUD)
01
Overview
Phase 2, open-label trial of acamprosate in alcohol use disorder (AUD) (2 arms), sponsored by Mayo Clinic. Primary endpoint: Adverse Events at 24 weeks. Started Sep 2020; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
MELD-Na < 20
Patients with MELD-Na score less than 20
MELD-Na >= 20
Patients with MELD-Na score 20 or more
03
Who it enrols
Adults with alcohol-related liver disease and AUD, abstinent for 2 weeks to 6 months, with GFR >= 30 ml/min and no significant heart failure.
04
Endpoints
Primary
Adverse Events
Secondary
Change in Alcohol Craving
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