Long-term Follow-up to Determine Outcome in Liver Disease (LOVE Study)

Universität des Saarlandes

Status: Not yet enrolling

Conditions: Steatotic Liver Disease of Mixed Origin (MetALD); ALD - Alcoholic Liver Disease; Steatotic Liver Disease; MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)

Study type: Observational

Funder types: Other

Identifiers

NCT06907563

LOVE study

Details and patient eligibility

About

The rational to conduct the LOVE study builds on the lack of available data on outcomes in steatotic liver disease in well characterized patients over a time frame of several years. At current limited data on liver-specific and overall outcome in patients with MASLD, MetALD and ALD are available. Liver histology is the only accepted surrogate to reasonably likely predict outcomes in patients with non-cirrhotic liver disease and is currently used in regulatory trials. To overcome the limitations of liver biopsy and use validated non-invasive tests (NITs) to predict outcomes, the LOVE study will be conducted based on existing cohort studies in well pheno- and genotyped patients and will inform on the relevant outcomes based on baseline and ongoing biomarker assessment. The overarching goal is to qualify a NIT for patient identification and preventive measures in the regulatory context.

Enrollment: 30,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previous Informed consent for cohort studies
• > 18 years of age
• Diagnosis of SLD (MASLD, MetALD, ALD)

Exclusion criteria

• No consent for previous cohort studies
• < 18 years of age
• No Diagnosis of SLD (MASLD, MetALD, ALD)

Trial design

30,000 participants in 1 patient group

European SLD Registry

Description:

The EU-SLD registry comprises patients from 18 european countries and a study cohort of n=8.984 with most recent cases recruited in the prospective LITMUS cohort study. Now followed up as part of the LOVE Study in the EU-LIVERAIM project.