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Recruiting Not applicable

Recompensation in Alcohol Related Hepatitis

NCT06740318 · tracked via the Priya Life Science Denmark tracker
Sponsor
Nina Kimer
Phase
Not applicable
Started
2024-11-25
Last updated
2025-02-27

Condition(s) studied

Alcoholic Hepatitis (AH)

Investigational drug(s) / intervention(s)

Motivational enhancement therapy

Motivational enhancement therapy: 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.

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Clinical suspicion of AH, supported by biochemistry (bilirubin 50 mmol/l or higher) and ultrasound or other imaging techniques. * Informed written consent. Exclusion Criteria: * People where the diagnosis of AH is questioned with reasonable doubt. * Withdrawal of informed consent. * Persons eligible for inclusion where the investigational program is delayed or not initiated within two months after the diagnosis of suspected AH. * Persons with hepatocellular carcinoma

Primary outcome measure(s)

  • Change from baseline in the proteomic profile — 12 months
    Change from baseline to 12 months in the proteomic profile in the liver tissue
  • Change from baseline in the lipidomic profile — 12 months
    Changes from basline to 12 months in the lipidomic profile in the liver tissue
  • Number of participants in recompensation — 12 months
    Number of patients who achieve recompensation/remission from AH after 12 months

Trial sites (1)

FacilityCityRegionStatus
University Hospital Hvidovre Hvidovre Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06740318 on ClinicalTrials.gov ↗ ← All trials in Denmark