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Long-term Follow-up to Determine Outcome in Liver Disease (LOVE Study)
Sponsor: Universität des Saarlandes
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
Conditions
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