HDVHDV750NCT06160635
D-SOLVE Cohorts (Cohort A and B)
An observational study of HDV and HDV Infection, run by Hannover Medical School at 4 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HDV, HDV Infection, Chronic Liver Disease
- How many people
- 750 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 22 Feb 2023to 30 Sep 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Anti-HDV positive
- ≥18 years old
- Sex: m/f/d
- Informed consent for prospective procedures
Who cannot join
- Anti-HDV negative
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Julia Kahlhöfer contact
4 sites in 4 countries
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School, Department of Gastroenterology, Hepatology, Infectious Disease and Endocrinology
Hanover, 30625
Heiner Wedemeyer
Italy1 site, 1 recruiting
- Not yet recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (University of Milan)
Milan
Pietro Lampertico
Romania1 site, 1 recruiting
- Recruiting
Institutul de Boli Infectioase "Prof. Dr. Matei Bals"
Bucharest, 021105
Florin Alexandru Caruntu, Dr.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital and Karolinska Institutet
Stockholm
Soo Aleman
About this study
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.
Read the detailed description
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:
- Helmholtz-Zentrum für Infektionsforschung (HZI), Germany
- Institut national de la santé et de la recherche médicale (INSERM)
- Karolinska Institutet (KI), Sweden
- Karolinska University Hospital / Region Stockholm (KUH), Sweden
- Policlinico of Milan (PFM), Italy
- National Institute for Infectious Diseases "Prof Dr Matei Balș" (INBIMB), Romania
- Helmholtz-Zentrum für Informationssicherheit (CISPA), Germany
The Cohorts and the biomarker screening are part of the EU-funded D-SOLVE Consortium.
- Conditions
- HDV, HDV Infection, Chronic Liver Disease
- Keywords
- HDV, Hepatitis Delta, chronic liver disease, patient cohort, biomarker
- Medical subject headings
- Hepatitis D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Cohort A: Patients chronically infected with HDV. Patients with and without cirrhosis and with and without viremia will be included. | |
| Cohort B | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (2)
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
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start22 Feb 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HDVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 750 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Karolinska Institutet, Helmholtz Centre for Infection Research, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, National Institute of Infectious Diseases Matei Bals
- Responsible party
- Sponsor
- Investigators
- Markus Cornberg, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160635
- Sponsor's protocol ID
- HDV750
- Acronym
- HDV750
- Status last verified
- Sep 2026
- First submitted
- 29 Nov 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-SOLVE Cohorts (Cohort A and B)
- ClinicalTrials.gov ID
- NCT06160635
- Acronym / sponsor ID
- HDV750 / HDV750
- Conditions
- HDV, HDV Infection, Chronic Liver Disease
- Keywords
- HDV, Hepatitis Delta, chronic liver disease, patient cohort, biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Karolinska Institutet, Helmholtz Centre for Infection Research, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, National Institute of Infectious Diseases Matei Bals
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Helmholtz-Zentrum für Infektionsforschung (HZI), Germany
- Institut national de la santé et de la recherche médicale (INSERM)
- Karolinska Institutet (KI), Sweden
- Karolinska University Hospital / Region Stockholm (KUH), Sweden
- Policlinico of Milan (PFM), Italy
- National Institute for Infectious Diseases "Prof Dr Matei Balș" (INBIMB), Romania
- Helmholtz-Zentrum für Informationssicherheit (CISPA), Germany
The Cohorts and the biomarker screening are part of the EU-funded D-SOLVE Consortium.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | –Cohort A: Patients chronically infected with HDV. Patients with and without cirrhosis and with and without viremia will be included. |
| Cohort B | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- Anti-HDV positive
- ≥18 years old
- Sex: m/f/d
- Informed consent for prospective procedures
Key exclusion criteria (1 listed)
- Anti-HDV negative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biosample Screening
Time frame: 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
2 secondary outcomes
Definition of the demographic, clinical and virological features of the cohort.
Time frame: 3 years
Identification of virological and immunological features and characteristics that relate to disease severity and treatment response.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
Related trials for HDV
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A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
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Hepatitis Delta Virus Infection: Cross-sectional Study in Patients With Chronic Hepatitis B Virus Infection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia Kahlhöfer contact
Markus Cornberg principal investigator
Hannover Medical School
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HDV and HDV Infection, run by Hannover Medical School at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Italy, Romania, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Dörge (+495115326057, doerge.petra@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biosample Screening (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.