Alcoholic Liver DiseaseNCT05855031
The Liver Care Trial
A study testing Transient Elastography in people with Alcoholic Liver Disease and Alcohol Use Disorder, run by Zealand University Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Alcoholic Liver Disease, Alcohol Use Disorder, Alcohol Abuse
- What is being tested?
- Transient Elastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 2 sitesDenmark
- Study dates
- 8 May 2023to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not speaking Danish or English
- Severe liver disease (known by the participant)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gro Askgaard, PHD contact
Denmark2 sites, 2 recruiting
- Recruiting
Novavi Køge
Køge, 4600
Pernille Dahlin, MD, 30291114, pedah@regionsjaelland.dk
- Recruiting
Novavi Roskilde
Roskilde, 4000
Pernille Dahlin, MD, 30291114, pedah@regionsjaelland.dk
About this study
Official title: The Liver Care Trial: Screening for Liver Disease in Individuals Attending Treatment for Alcohol Use Disorder - a Randomized Controlled Study
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
- Alcoholic Liver Disease, Alcohol Use Disorder, Alcohol Abuse, Alcoholism, Fibrosis, Liver, Alcohol-Related Disorders
- Being tested
- Transient Elastography
- Keywords
- Screening, Fibroscan, Liver stiffness measurement, abstinence
- Medical subject headings
- Liver Diseases, Alcoholic, Alcoholism, Liver Cirrhosis, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transient ElastographyDiagnostic test
Also called Fibroscan, Liver stiffness measurement
One transient elastography 1-2 weeks after randomization
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | An invitation to a liver stiffness measurement (Transient Elastography), to blood sampling and a leaflet on alcohol-related disease. Receives: Diagnostic Test: Transient Elastography |
| Control | No intervention | An invitation to screening by blood sampling with Fib-4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol abstinence or light consumption (≤ 10 units/week) the last 30 days (yes/no) assessed 6 months since randomization
Assessed By telephone interview or health record
Measured: Assessed 6 months after randomization
Secondary outcomes (2)
Heavy drinking days last 30 days
Assessed by telephone interview or health record
Measured: Assessed 6 months after since randomization
Change in AUDIT-C score (yes or no) since randomization
AUDIT: the Alcohol Use Disorders Identification Test is a validated manual for use in primary care to identify persons with hazardous and harmful patterns of alcohol consumption
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start8 May 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized concealed allocation to intervention or control
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novavi, Aarhus University Hospital, Frederiksberg University Hospital, University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Gro Askgaard, PHD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855031
- Sponsor's protocol ID
- SJ-995
- Status last verified
- May 2023
- First submitted
- 20 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41152905
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Liver Care Trial: Screening for Liver Disease in Individuals Attending Treatment for Alcohol Use Disorder - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05855031
- Acronym / sponsor ID
- SJ-995
- Conditions
- Alcoholic Liver Disease, Alcohol Use Disorder, Alcohol Abuse, Alcoholism, Fibrosis, Liver, Alcohol-Related Disorders
- Keywords
- Screening, Fibroscan, Liver stiffness measurement, abstinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Novavi, Aarhus University Hospital, Frederiksberg University Hospital, University of Copenhagen
- Study start
- 8 May 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized concealed allocation to intervention or control
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: Transient ElastographyAn invitation to a liver stiffness measurement (Transient Elastography), to blood sampling and a leaflet on alcohol-related disease. |
| Control | No intervention | –An invitation to screening by blood sampling with Fib-4 |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Not speaking Danish or English
- Severe liver disease (known by the participant)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transient ElastographyAlso: Fibroscan, Liver stiffness measurementOne transient elastography 1-2 weeks after randomization | Diagnostic test | Intervention |
Primary outcome
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
Assessed By telephone interview or health record
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 41152905Dahlin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gro Askgaard, PHD contact
Gro Askgaard, PHD principal investigator
Zealand University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transient Elastography in people with Alcoholic Liver Disease and Alcohol Use Disorder, run by Zealand University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pernille Dahlin, MD (+45 30291114, pedah@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05855031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.