D-SOLVE Cohorts (Cohort a and B)

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Anti-HDV positive

• ≥18 years old

• Sex: m/f/d

• Informed consent for prospective procedures

Locations
Other Locations
Germany
Hannover Medical School, Department of Gastroenterology, Hepatology, Infectious Disease and Endocrinology
RECRUITING
Hanover
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (University of Milan)
NOT_YET_RECRUITING
Milan
Romania
Institutul de Boli Infectioase Prof. Dr. Matei Bals
RECRUITING
Bucharest
Sweden
Karolinska University Hospital and Karolinska Institutet
RECRUITING
Stockholm
Contact Information
Primary
Petra Dörge
doerge.petra@mh-hannover.de
+495115326057
Backup
Julia Kahlhöfer
kahlhoefer.julia@mh-hannover.de
Time Frame
Start Date: 2023-02-22
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 750
Treatments
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.
Sponsors
Leads: Hannover Medical School
Collaborators: Karolinska Institutet, Karolinska University Hospital, Helmholtz Centre for Infection Research, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, National Institute of Infectious Diseases Matei Bals

This content was sourced from clinicaltrials.gov