Generate prospective follow-up data to increase our understanding of this rare disease.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Generate prospective population based follow-up data of a homogeneously managed
hepatitis delta cohortGenerate prospective population based follow-up data of a
homogeneously managed hepatitis delta cohort
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.
Secondary outcome
Compare the outcomes of this cohort to a historic cohort identified in the
DREAM-1 project
Background summary
Hepatitis delta virus (HDV) is a defective RNA virus that requires presence of
hepatitis B virus (HBV) to complete virion assembly and secretion. HBV-HDV
coinfection (*hepatitis delta*) has been associated with severe liver injury
that may result in rapid progression to cirrhosis and hepatic decompensation,
as well as a higher risk of liver cancer when compared to patients with HBV
mono-infection. Given the low incidence of hepatitis D, experience in caring
for individuals with hepatitis delta is limited and management practices vary.
Study 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 burden and risks
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.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
- Active hepatitis delta based on a positive anti-HDV and a positive HDV-RNA
test
- Patients must be >=18 years
- Written informed consent
Exclusion criteria
none
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84655.078.23 |