Standardising Care for Hepatitis Delta in the Netherlands

Hepatitis D Clinical Trial

— DREAM-2  

Official title:

Standardising Care for Hepatitis Delta in the Netherlands

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05903742
• Other study ID #: 10022
• Status: Recruiting
• Start date: January 22, 2024
• Est. completion date: September 1, 2031

Study information

• Verified date: April 2024
• Source: Erasmus Medical Center
• Contact: Lesley Patmore, MD
• Phone: +31629677982
• Email: l.patmore[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 1, 2031
• Est. primary completion date: September 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis D

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Maag Lever Darm Stichting

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prospective population based follow-up data	Generate prospective population based follow-up data of a homogeneously managed hepatitis delta cohort	5 year