German SLD-Registry (Deutsches SLD-Register)
German SLD-Registry Characterization of Patients with Steatotic Liver Disease (SLD) in Germany - Phase 1 (observation of the Natural Course)
1 other identifier
observational
5,000
1 country
14
Brief Summary
Characterization of patients with steatotic liver disease (SLD) The German SLD-Registry (Deutsches SLD-Register) a project of the German Liver Foundation (Deutsche Leberstiftung), managed by Leberstiftungs-GmbH Deutschland. The German NAFLD-Registry is financially supported by: Advanz Pharma Specialty Medicine Deutschland GmbH und Gilead Sciences GmbH (Grant to German Livber Foundation) sowie Novo Nordisk Pharma GmbH (directly via Leberstiftungs-GmbH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
January 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2036
March 6, 2025
March 1, 2025
16 years
November 30, 2020
March 4, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Progression of liver fibrosis
Fibrosis stage is measured by elastography (elastometry kPa value).
through study completion, an average of 1 year
Activity of metabolic dysfunction-associated steatohepatitis (MASH)
Activity is measured via histology (NAFLD activity score represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8.)
through study completion, an average of 1 year
Cardiovascular events
The onset of the clinical outcome cardiovascular events (yes/no)
through study completion, an average of 1 year
Tumor diseases
The onset of the clinical outcome tumor diseases (yes/no)
through study completion, an average of 1 year
Study Arms (1)
SLD patients
No intervention
Eligibility Criteria
The number of patients to be enrolled with SLD is limited to 10,000.
You may qualify if:
- diagnosed SLD based on the following criteria:
- typical finding of hepatic steatosis (abdominal ultrasound and/or pathological CAP value (latter is optional)
- Evaluation of SLD degree by NAFLD Fibrosis score and/or FIB-4-Index and/or transient elastography
- Evaluation of metabolic syndrome
- credible assessment of alcohol consumption
- written informed consent
You may not qualify if:
- patients with other hepatologic diseases (chronically viral, metabolic, autoimmune origin
- patients receiving hepatotoxic medications over a longer period (e.g. methotrexate, amiodarone, longterm NSAR intake)
- malignant disease with a life expectancy \<12 months
- participation in clinical interventional/pivotal studies
- inability to provide written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Infektiologisches Zentrum Steglitz
Berlin, Germany
Leber- und Studienzentrum Checkpoint
Berlin, Germany
MVZ für Gastroenterologie am Bayerischen Platz
Berlin, Germany
Praxis für Innere Medizin mit Schwerpunkt Gastroenterologie Dr. med. Jeannette Schwenzer
Berlin, Germany
MVZ Viszeralmedizin GmbH
Cologne, Germany
Praxis Ludwig und Dikopoulos
Dornstadt, Germany
Fachinternistische Schwerpunktpraxis
Hamburg, Germany
Gastroenterologische Studiengesellschaft Herne
Herne, Germany
Leberstudienzentrum Kiel
Kiel, Germany
Eugastro GmbH
Leipzig, Germany
MVZ Dres. Eisenbach,Simon, Schwarz GbR
Leverkusen, Germany
Praxis Dr. med. Kerstin Stein
Magdeburg, Germany
CIM GmbH
Münster, Germany
St. Josefs-Hospital Medizinische Klinik II
Wiesbaden, Germany
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Zeuzem, Prof. Dr.
Johann Wolfgang Goethe University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2020
First Posted
January 25, 2021
Study Start
December 1, 2020
Primary Completion (Estimated)
November 30, 2036
Study Completion (Estimated)
November 30, 2036
Last Updated
March 6, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share