Recompensation in Alcohol Related Hepatitis

NCT06740318 | Recruiting

• 1 other identifier: H-24040990
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Genetic activity and metabolic changes may be part of the pathogenesis in alcohol related hepatitis. We do not know exactly how alcohol cessation affects liver functions and metabolism. The aim of this study is to assess the impact of alcohol cessation in patients with alcohol related hepatitis and gain knowledge of the metabolic and genetic functions of the liver during remission and recompensation from alcohol related hepatitis. The study will assess

1. 1.The effect of alcohol cessation on the liver.
2. 2.The biological mechanisms involved in healing after alvohol-cessation
3. 3.The effect of motivational enhcament therapy in alcohol cessation after alcohol related hepatitis.
4. 4.The metabolic changes of lipids and proteins in the liver Participants are offered motivational enhancement therapy and standard of care.

Conditions

Alcoholic Hepatitis (AH)

Keywords

alcohol use disorder; motivational enhancement therapy; metabolomics; incidence cohort; alcohol related hepatitis

Outcome Measures

Primary Outcomes (3)

• Change from baseline in the proteomic profile

  Change from baseline to 12 months in the proteomic profile in the liver tissue

  12 months

• Change from baseline in the lipidomic profile

  Changes from basline to 12 months in the lipidomic profile in the liver tissue

  12 months

• Number of participants in recompensation

  Number of patients who achieve recompensation/remission from AH after 12 months

  12 months

Secondary Outcomes (2)

• Change in alcohol use from baseline

  12 months

• Effect of motivational enhancement therapy

  3 months

Study Arms (1)

Treatment

EXPERIMENTAL

Standard of Care: medical treatment of alcohol use disorder and motivational enhacement therapy, three interviews within three months.

Other: Motivational enhancement therapy

Interventions

Motivational enhancement therapy OTHER

The intervention consists of three motivational interviews with the focus to enhance the participants motivation to enter treatment of alcohol use disorder. the interviews are structured and based on the model Motivational enhancement therapy.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical suspicion of AH, supported by biochemistry (bilirubin 50 mmol/l or higher) and ultrasound or other imaging techniques.
• Informed written consent.

You may not qualify if:

• People where the diagnosis of AH is questioned with reasonable doubt.
• Withdrawal of informed consent.
• Persons with hepatocellular carcinoma

Sponsors & Collaborators

• Nina Kimer: lead
• Copenhagen University Hospital, Hvidovre: collaborator
• The Novo Nordisk Foundation Center for Basic Metabolic Research: collaborator

Study Sites (1)

University Hospital Hvidovre

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Hepatitis, Alcoholic; Alcoholism

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Nina Kimer, MD, PhD

CONTACT

+4525140961; nina.kimer@regionh.dk

Niels P Klausen, MD

CONTACT

+4538621968; niels.peter.riedel.klausen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Model Details: Motivational enhancement therapy in three sessions within three months from diagnosis are applied in addition to standard of care.

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 2029-2034
• Access Criteria: Proposals for data access will be evaluated in the study group.

Locations

DK (1)