DREAM-2: Standardising Care for Hepatitis Delta in the Netherlands

Sponsor

Erasmus Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05903742

Collaborator

Maag Lever Darm Stichting (Other)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis D

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Standardising Care for Hepatitis Delta in the Netherlands

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2030

Anticipated Study Completion Date :

Sep 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Hepatitis delta cohort hepatitis delta patients aged ≥18 years

Outcome Measures

Primary Outcome Measures

Prospective population based follow-up data [5 year]
Generate prospective population based follow-up data of a homogeneously managed hepatitis delta cohort

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Erasmus Medical Center
Maag Lever Darm Stichting

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Milan Sonneveld, MD, PhD, Erasmus Medical Center

ClinicalTrials.gov Identifier:

NCT05903742

Other Study ID Numbers:

10022

First Posted:

Jun 15, 2023

Last Update Posted:

Jun 15, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatitis A

Hepatitis D

Hepatitis

Study Results

No Results Posted as of Jun 15, 2023