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NOT YET RECRUITING
NCT06907563

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

Sponsor: Universität des Saarlandes

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30000

Start Date

2025-04-15

Completion Date

2035-12-31

Last Updated

2025-04-02

Healthy Volunteers

No

Locations (4)

Hôpital de la Pitié Salpêtrière

Paris, France

University Medical Center Saarland, Department of Internal Medicine II

Homburg, Saarland, Germany

Division of Gastroenterology, Department of Medical Sciences, University of Turin

Turin, Italy

Translational & Clinical Research Institute Faculty of Medical Sciences

Newcastle upon Tyne, United Kingdom