Standardising Care for Hepatitis Delta in the Netherlands
NCT ID: NCT05903742
Last Updated: 2024-04-03
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
80 participants
OBSERVATIONAL
2024-01-22
2031-09-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hepatitis delta cohort
hepatitis delta patients aged ≥18 years
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients must be ≥18 years
* Written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Maag Lever Darm Stichting
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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Milan Sonneveld
Principal investigator
Locations
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Erasmus MC
Rotterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Lesley Patmore, MD
Role: primary
Other Identifiers
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10022
Identifier Type: -
Identifier Source: org_study_id
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