An observational study in Hepatitis D, sponsored by Erasmus Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Erasmus Medical Center · Observational
Rationale: 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.
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
63 studies on the registry are indexed under Hepatitis D; 21 are open to participants now.
This study's planned enrollment of 80 is below the median of 326 across 29 observational studies indexed under Hepatitis D.
Browse Hepatitis D studies →Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All hepatitis delta patients currently in care at the participating sites will be asked to enter the study. The exact number of eligible patients is unclear, but based on the DREAM-1 study we expect to enrol up to 150 patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
hepatitis delta patients aged ≥18 years
Prospective population based follow-up data
Generate prospective population based follow-up data of a homogeneously managed hepatitis delta cohort
Time frame: 5 year
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Sep 2030, 79 months after the start.
How these figures are worked out, and which studies are left out of them.
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