NCT06160635

Brief Summary

Hepatitis D is by far the most severe form of chronic viral hepatitis, frequently leading to liver failure, hepatocellular carcinoma and death. Hepatitis D is caused by coinfection Hepatitis D is caused by co-infection with hepatitis B virus (HBV) and hepatitis D virus (HDV). This multicenter cohort should enable a comprehensive and unbiased biomarker screening of well-defined HDV-infected patients, followed by mechanistic studies to determine the functional role of distinct molecules. Patient surveillance strategies and antiviral treatment approaches could be personalized which should reduce clinical and social disease burden, improve quality of life and save direct and indirect costs caused by HDV infection.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Feb 2023

Typical duration for all trials

Geographic Reach
4 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2023Sep 2026

Study Start

First participant enrolled

February 22, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

3.6 years

First QC Date

November 29, 2023

Last Update Submit

March 11, 2025

Conditions

HDVHDV InfectionChronic Liver Disease

Keywords

HDVHepatitis Deltachronic liver diseasepatient cohortbiomarker

Outcome Measures

Primary Outcomes (1)

  • Biosample Screening

    Identification of biomarkers that are associated with disease control, progression and treatment response by a multiomics approach that includes the investigation of: - the genome by the Illumina Infinium Global Screening array - the transcriptome by RNA-sequencing and single-cell RNA-sequencing (subset of samples) - the proteome by the Olink technology (high throughput proximity extension assay) - the metabolome by HPLC 1H-NMR (\~2k metabolite features) - the methylome (Illumina 850k array) - immune phenotypes by high dimensional spectral flow cytometry - Spatial transcriptomics and multiplex imaging of HDV-patient liver biopsies

    3 years

Secondary Outcomes (2)

  • Definition of the demographic, clinical and virological features of the cohort.

    3 years

  • Identification of virological and immunological features and characteristics that relate to disease severity and treatment response.

    3 years

Study Arms (2)

Cohort A

Cohort A: Patients chronically infected with HDV. Patients with and without cirrhosis and with and without viremia will be included.

Cohort B

Cohort B: Patients chronically infected with HDV and with available historical liver biopsies (5-20 years old biopsies) and clinical follow-up data or current patients willing to receive a core biopsy or fine-needle liver-cell aspirate (FNA). Patients with and without cirrhosis and with and without viremia will be included.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients chronically infected with the hepatitis D virus (anti-HDV positive) can be included. For cohort B historical liver biopsies need to be available.

You may qualify if:

  • Anti-HDV positive
  • ≥18 years old
  • Sex: m/f/d
  • Informed consent for prospective procedures

You may not qualify if:

  • Anti-HDV negative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hannover Medical School, Department of Gastroenterology, Hepatology, Infectious Disease and Endocrinology

Hanover, 30625, Germany

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (University of Milan)

Milan, Italy

NOT YET RECRUITING

Institutul de Boli Infectioase "Prof. Dr. Matei Bals"

Bucharest, 021105, Romania

RECRUITING

Karolinska University Hospital and Karolinska Institutet

Stockholm, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biosamples: As part of the routine visit, structured biosampling for research purposes. Biosamples are collected as part of the clinical routine blood draw every 6 to 12 months. PBMC, plasma and samples for genetic studies are collected. Approximately 80 ml of additional blood is drawn.

MeSH Terms

Conditions

Hepatitis D

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Markus Cornberg

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Dörge

CONTACT

+495115326057doerge.petra@mh-hannover.de

Julia Kahlhöfer

CONTACT

kahlhoefer.julia@mh-hannover.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

February 22, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations

DE(1)RO(1)IT(1)SE(1)