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NCT06907563Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 2 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
30000 (estimated)
First submitted
26 Mar 2025
Start date
15 Apr 2025
Primary completion date
31 Dec 2030
Lead sponsor
Universität des Saarlandes
NCT number
NCT06907563

What you commit to

  • Study type: Observational
  • Planned participants: 30000
  • From 15 Apr 2025 to the primary completion date, 31 Dec 2030
  • 4 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • No consent for previous cohort studies

Age

  • \< 18 years of age

Other

  • No Diagnosis of SLD (MASLD, MetALD, ALD)

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Medical Center Saarland, Department of Internal Medicine II
Coordinator of this site? Confirm its status
HomburgGermanyUnknown status
Hôpital de la Pitié-Salpêtrière
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Translational & Clinical Research Institute Faculty of Medical Sciences
Coordinator of this site? Confirm its status
Newcastle upon TyneUnited KingdomUnknown status
Division of Gastroenterology, Department of Medical Sciences, University of Turin
Coordinator of this site? Confirm its status
TurinItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.