D-SOLVE Cohorts (Cohort a and B)

NCT06160635 · tracked via the Priya Life Science Germany tracker

Sponsor

Hannover Medical School

Phase

Observational

Started

2023-02-22

Last updated

2025-03-12

Condition(s) studied

HDVHDV InfectionChronic Liver Disease

Study summary

Hepatitis D is by far the most severe form of chronic viral hepatitis, frequently leading to liver failure, hepatocellular carcinoma and death. Hepatitis D is caused by coinfection Hepatitis D is caused by co-infection with hepatitis B virus (HBV) and hepatitis D virus (HDV).

This multicenter cohort should enable a comprehensive and unbiased biomarker screening of well-defined HDV-infected patients, followed by mechanistic studies to determine the functional role of distinct molecules. Patient surveillance strategies and antiviral treatment approaches could be personalized which should reduce clinical and social disease burden, improve quality of life and save direct and indirect costs caused by HDV infection.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Anti-HDV positive * ≥18 years old * Sex: m/f/d * Informed consent for prospective procedures Exclusion Criteria: * Anti-HDV negative

Primary outcome measure(s)

Biosample Screening — 3 years
Identification of biomarkers that are associated with disease control, progression and treatment response by a multiomics approach that includes the investigation of: - the genome by the Illumina Infinium Global Screening array - the transcriptome by RNA-sequencing and single-cell RNA-sequencing (subset of samples) - the proteome by the Olink technology (high throughput proximity extension assay) - the metabolome by HPLC 1H-NMR (\~2k metabolite features) - the methylome (Illumina 850k array) - immune phenotypes by high dimensional spectral flow cytometry - Spatial transcriptomics and multiplex imaging of HDV-patient liver biopsies

Trial sites (4)

Facility	City	Region	Status
Hannover Medical School, Department of Gastroenterology, Hepatology, Infectious Disease and Endocrinology	Hanover	Germany	Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (University of Milan)	Milan	Italy	Not Yet Recruiting
Institutul de Boli Infectioase "Prof. Dr. Matei Bals"	Bucharest	Romania	Recruiting
Karolinska University Hospital and Karolinska Institutet	Stockholm	Sweden	Recruiting

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Other trials for the same condition

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10119473 -VIROMARKERS HDV Biomarkers Study Starting soon

Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease. Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06160635 on ClinicalTrials.gov ↗ ← All trials in Germany