Standardising Care for Hepatitis Delta in the Netherlands

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Objective: Generate prospective follow-up data to increase our understanding of this rare disease. Study design: Prospective observational cohort study spanning 5 years, during which we will collect standard clinical data as well as blood samples and quality of life questionnaires. Study population: hepatitis delta patients aged ≥18 years Intervention (if applicable): not applicable Main study parameters/endpoints: Incidence of liver related events (liver cancer, (decompensation of) cirrhosis, liver transplantation) during follow-up and changes in markers of viral replication, inflammatory activity and liver stiffness over time. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks associated with participation can be considered negligible and the burden can be considered minimal. The only additional action that the participants must perform are the filling out of two annual quality of life questionnaires, which are considered non-invasive, and collection of 10 ml blood during regular blood sample collections

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

• Active hepatitis delta based on a positive anti-HDV and a positive HDV-RNA test

• Patients must be ≥18 years

• Written informed consent

Locations
Other Locations
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Contact Information
Primary
Lesley Patmore, MD
l.patmore@erasmusmc.nl
+31629677982
Time Frame
Start Date: 2024-01-22
Estimated Completion Date: 2031-09-01
Participants
Target number of participants: 80
Treatments
Hepatitis delta cohort
hepatitis delta patients aged ≥18 years
Sponsors
Collaborators: Maag Lever Darm Stichting
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov