Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT04287920
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2020-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Acamprosate Safe to Use in Individuals With Liver Disease.
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Phase II Study Evaluating the Safety of Acamprosate for Alcohol Use Disorder in Alcohol-related Liver Disease
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Is acamprosate safe to use in individuals with liver disease.
Detailed Description:
Adult patients aged 21 or over with a diagnosis of alcohol-related liver disease and alcohol use disorder (AUD) and abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: