Clinical trial NCT06160635: D-SOLVE Cohorts (Cohort a and B)
Official title: D-SOLVE Cohorts (Cohort a and B)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HDV
HDV Infection
Chronic Liver Disease
Keywords: HDV
Hepatitis Delta
chronic liver disease
patient cohort
biomarker
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Karolinska Institutet
name: Helmholtz Centre for Infection Research
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: National Institute of Infectious Diseases Matei Bals
First posted: 2023-12-07
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Anti-HDV negative

Primary outcomes:
measure: Biosample Screening
timeFrame: 3 years
Secondary outcomes:
measure: Definition of the demographic, clinical and virological features of the cohort.
timeFrame: 3 years
measure: Identification of virological and immunological features and characteristics that relate to disease severity and treatment response.
timeFrame: 3 years
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Department of Gastroenterology, Hepatology, Infectious Disease and Endocrinology
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (University of Milan)
city: Bucharest
country: Romania
facility: Institutul de Boli Infectioase "Prof. Dr. Matei Bals"
city: Stockholm
country: Sweden
facility: Karolinska University Hospital and Karolinska Institutet
Study officials:
affiliation: Hannover Medical School
name: Markus Cornberg
role: PRINCIPAL_INVESTIGATOR
References: