The Liver Care Trial

NCT ID: NCT05855031

Last Updated: 2023-05-17

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

RECRUITING

Clinical Phase

NA

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-08

Study Completion Date

2027-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Alcoholic Liver Disease Alcohol Use Disorder Alcohol Abuse Alcoholism Fibrosis, Liver Alcohol-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized concealed allocation to intervention or control
Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Intervention

An invitation to a liver stiffness measurement (Transient Elastography), to blood sampling and a leaflet on alcohol-related disease.

Group Type EXPERIMENTAL

Transient Elastography

Intervention Type DIAGNOSTIC_TEST

One transient elastography 1-2 weeks after randomization

Control

An invitation to screening by blood sampling with Fib-4

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transient Elastography

One transient elastography 1-2 weeks after randomization

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Fibroscan Liver stiffness measurement

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novavi

UNKNOWN

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Frederiksberg University Hospital

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gro Askgaard, PHD

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Locations

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Novavi Køge

Køge, , Denmark

Site Status RECRUITING

Novavi Roskilde

Roskilde, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Pernille Dahlin, MD

Role: CONTACT

+45 30291114

Gro Askgaard, PHD

Role: CONTACT

Facility Contacts

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Pernille Dahlin, MD

Role: primary

Pernille Dahlin, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 41152905 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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SJ-995

Identifier Type: -

Identifier Source: org_study_id

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