Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
750 participants
OBSERVATIONAL
2023-02-22
2026-09-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
OTHER
Study Groups
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Cohort A
Cohort A: Patients chronically infected with HDV. Patients with and without cirrhosis and with and without viremia will be included.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* ≥18 years old
* Sex: m/f/d
* Informed consent for prospective procedures
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Karolinska Institutet
OTHER
Helmholtz Centre for Infection Research
OTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
National Institute of Infectious Diseases Matei Bals
UNKNOWN
Hannover Medical School
OTHER
Responsible Party
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Principal Investigators
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Markus Cornberg
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
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Hannover Medical School, Department of Gastroenterology, Hepatology, Infectious Disease and Endocrinology
Hanover, , Germany
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (University of Milan)
Milan, , Italy
Institutul de Boli Infectioase "Prof. Dr. Matei Bals"
Bucharest, , Romania
Karolinska University Hospital and Karolinska Institutet
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Heiner Wedemeyer
Role: primary
Pietro Lampertico
Role: primary
Florin Alexandru Caruntu, Dr.
Role: primary
Soo Aleman
Role: primary
Other Identifiers
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HDV750
Identifier Type: -
Identifier Source: org_study_id
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