D-SOLVE Cohorts (Cohort A and B)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHannover Medical School
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Anti-HDV positive
≥18 years old
Sex: m/f/d
Informed consent for prospective procedures
Disqualifiers
Anti-HDV negative
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
750 Participants
are grouped into 2 trial groupsGroup A: Cohort A
Group B: Cohort B
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hannover Medical School
Lead sponsor
Karolinska University Hospital
Collaborator
Karolinska Institutet
Collaborator
Helmholtz Centre for Infection Research
Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborator
National Institute of Infectious Diseases Matei Bals
Collaborator
Source ClinicalTrials.gov