D-SOLVE Cohorts (Cohort a and B) (HDV750)

Hannover Medical School (MHH)

Status: Enrolling

Conditions: Chronic Liver Disease; HDV Infection; HDV

Study type: Observational

Funder types: Other

Identifiers

NCT06160635

HDV750

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Anti-HDV negative

Trial design

750 participants in 2 patient groups

Cohort A

Description:

Cohort A: Patients chronically infected with HDV. Patients with and without cirrhosis and with and without viremia will be included.

Cohort B

Description:

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.