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

NCT06907563 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30000

Last updated 2025-04-02

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Universitatsmedizin Mainz - 1. Medizinische Klinik

    collaborator OTHER

  • Newcastle University

    collaborator OTHER

  • Barcelona Institute for Global Health

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • University of Turin, Italy

    collaborator OTHER

  • Universität des Saarlandes

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2030-12-31
Completion
2035-12-31

Countries

  • France
  • Germany
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06907563 on ClinicalTrials.gov