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Not yet recruiting NCT06907563

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

— Observational 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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry 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. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Germany, Italy, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Major-adverse liver outcomes (MALO) [Time frame: 5 years follow-up time]
  • All-cause mortality [Time frame: 5 years follow-up time]
Secondary outcome measures (4)
  • Health-related quality of life (HRQL) [Time frame: 5 years]
  • Assess prognostic biomarkers and develop a novel tool to integrate them into a digital tool to predict outcomes [Time frame: 5 years]
  • Major adverse cardiac events (MACE) [Time frame: 5 years]
  • Development of relevant clinical outcomes [Time frame: 5 years]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpital de la Pitié Salpêtrière — Paris
Germany · 1 center
  • University Medical Center Saarland, Department of Internal Medicine II — Homburg
Italy · 1 center
  • Division of Gastroenterology, Department of Medical Sciences, University of Turin — Turin
United Kingdom · 1 center
  • Translational & Clinical Research Institute Faculty of Medical Sciences — Newcastle upon Tyne

Identifiers

NCT: NCT06907563 · LOVE study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗