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

NCT ID: NCT06907563

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-15

Study Completion Date

2035-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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European SLD Registry

The EU-SLD registry comprises patients from 18 european countries and a study cohort of n=8.984 with most recent cases recruited in the prospective LITMUS cohort study. Now followed up as part of the LOVE Study in the EU-LIVERAIM project.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitatsmedizin Mainz - 1. Medizinische Klinik

OTHER

Sponsor Role collaborator

Newcastle University

OTHER

Sponsor Role collaborator

Barcelona Institute for Global Health

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role collaborator

University of Turin, Italy

OTHER

Sponsor Role collaborator

Universität des Saarlandes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital de la Pitié Salpêtrière

Paris, , France

Site Status

University Medical Center Saarland, Department of Internal Medicine II

Homburg, Saarland, Germany

Site Status

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

Turin, , Italy

Site Status

Translational & Clinical Research Institute Faculty of Medical Sciences

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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France Germany Italy United Kingdom

Central Contacts

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Jörn M. Schattenberg, MD

Role: CONTACT

+49684116 ext. 15027

Facility Contacts

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Scientific Affaires Officer, PhD, MPH

Role: primary

Division of Gastroenterology, Department of Medical Sciences

Role: primary

0039 11 6333272

Kristy Wonders

Role: primary

Other Identifiers

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LOVE study

Identifier Type: -

Identifier Source: org_study_id

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