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Recruiting NCT05855031

The Liver Care Trial

No phase Interventional Alcoholic Liver Disease Alcohol Use Disorder Alcohol Abuse Alcoholism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transient Elastography.
Who it may be relevant to
Registry conditions: Alcoholic Liver Disease, Alcohol Use Disorder, Alcohol Abuse, Alcoholism. Basic parameters: 18 years — 110 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Liver Care Trial: Screening for Liver Disease in Individuals Attending Treatment for Alcohol Use Disorder - a Randomized Controlled Study

Overview

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.

Interventions

  • Diagnostic test Transient Elastography
    One transient elastography 1-2 weeks after randomization

Primary outcome measures

  • Alcohol abstinence or light consumption (≤ 10 units/week) the last 30 days (yes/no) assessed 6 months since randomization [Time frame: Assessed 6 months after randomization]
Secondary outcome measures (2)
  • Heavy drinking days last 30 days [Time frame: Assessed 6 months after since randomization]
  • Change in AUDIT-C score (yes or no) since randomization [Time frame: 6 months after randomization]

Eligibility criteria

Inclusion criteria

  • Attending outpatient treatment for alcohol use disorder (international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use) at Novavi Køge or Novavi Roskilde
  • Informed written consent

Exclusion criteria

  • Not speaking Danish or English
  • Severe liver disease (known by the participant)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Screening

Study locations

Denmark · 2 centers
  • Novavi Køge — Køge
  • Novavi Roskilde — Roskilde

Publications

  • Dahlin P, Jepsen P, Molzen L, Madsen LG, Wegmann During S, Benthien KS, Winther-Jensen M, Grew JC, Kirk JW, Jensen KJ, Petersen J, Askgaard G. The Liver Care Trial: screening for liver disease in individuals attending treatment for alcohol use disorder-study protocol for a randomized controlled study. Trials. 2025 Oct 28;26(1):448. doi: 10.1186/s13063-025-09151-8. PMID 41152905

Identifiers

NCT: NCT05855031 · SJ-995

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗