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The Liver Care Trial

NCT05855031 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2023-05-17

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the efficacy of screening for liver disease with liver stiffness measurement on abstinence or light consumption after 6 months in individuals who are receiving treatment for alcohol use disorder and without a history of liver disease. The investigators will conduct a randomized controlled trial with concealed allocation comparing A) an invitation to a liver stiffness measurement, blood sampling and leaflet on alcohol-related disease (intervention) with B) an invitation to blood sampling (control). The primary outcome is 'abstinence or light consumption' (≤ 10 units/week) throughout the last months, and assessed 6 months after randomization.

Conditions

Interventions

DIAGNOSTIC_TEST

Transient Elastography

One transient elastography 1-2 weeks after randomization

Sponsors & Collaborators

  • Novavi

    collaborator UNKNOWN

  • Aarhus University Hospital

    collaborator OTHER

  • Frederiksberg University Hospital

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Gro Askgaard, PHD · Zealand University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-08
Primary Completion
2026-11-01
Completion
2027-05-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05855031 on ClinicalTrials.gov