An observational study in HDV, HDV Infection and Chronic Liver Disease, sponsored by Hannover Medical School. Recruiting at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Hannover Medical School · Observational
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.
The D-SOLVE consortium ("Understanding the individual host response against Hepatitis D Virus to develop a personalized approach for the management of hepatitis D"), aims for an unbiased screening of a large multicenter cohort of well-defined HDV-infected patients to better understand individual factors determining the outcome of infection and to identify subjects benefitting from currently available treatments.
The D-SOLVE cohorts will be collected retrospectively as well as prospectively with clinical and virological data and biomaterial for the biomarker analysis. The aim of the cohorts is as following:
Cohort A: To define the demographic, clinical, virological, and immunological features of a large cross-sectional cohort of 750 untreated and treated HDV patients at 4 EU centers. To compare these features among patients with different origin, gender, disease severity and treatment. To collect biological material to generate translational studies, aimed to better understand pathogenesis, natural history and treatment response.
Cohort B: To identify histological and immunological features that are associated with fibrosis progression and clinical complications in patients with chronic HDV infection.
The D-SOLVE consortium has received funding from the Horizon 2020 EU Horizon Call "Personalised medicine and infectious diseases: understanding the individual host response to viruses (e.g. SARS-CoV-2)" of the European Union (grant agreement No 101057917). The consortium is coordinated by Hannover Medical School (MHH) and the Centre for Individualised Infection Medicine (CiiM). Other partners are:
The Cohorts and the biomarker screening are part of the EU-funded D-SOLVE Consortium.
80 studies on the registry are indexed under Hepatitis D; 24 are open to participants now.
This study's planned enrollment of 750 is above the median of 326 across 39 observational studies indexed under Hepatitis D.
Browse Hepatitis D studies →Hannover Medical School is the lead sponsor of 198 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All adult patients chronically infected with the hepatitis D virus (anti-HDV positive) can be included. For cohort B historical liver biopsies need to be available.
Exclusion Criteria:
Cohort A: Patients chronically infected with HDV. Patients with and without cirrhosis and with and without viremia will be included.
Cohort B: Patients chronically infected with HDV and with available historical liver biopsies (5-20 years old biopsies) and clinical follow-up data or current patients willing to receive a core biopsy or fine-needle liver-cell aspirate (FNA). Patients with and without cirrhosis and with and without viremia will be included.
Biosample Screening
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
Time frame: 3 years
Definition of the demographic, clinical and virological features of the cohort.
Identification of immunological determinants of liver disease progression, viral control and treatment response by - scRNA/ATAC sequencing of Ag-specific T cells, NK cells and MAIT cells (PBMC) - spatial multiomics with feature barcoding technology of liver core biopsies - Validation of findings by 29-color flow cytometry, hepatoma HDV infection system and respective mouse models
Time frame: 3 years
Identification of virological and immunological features and characteristics that relate to disease severity and treatment response.
Establishment of a computational model to predict immune responses and disease phenotype
Time frame: 3 years
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Hannover Medical School