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Characterization of intrahepatic immune responses and gene expression profiles in patients with chronic hepatitis Delta

Characterization of intrahepatic immune responses and gene expression profiles in patients with chronic hepatitis Delta - RAPID

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56721
Enrollment
20
Registered
2023-11-05
Start date
2024-05-08
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis Delta viral liver inflammation Viral liver inflammation

Interventions

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Active hepatitis delta based on a positive anti-HDV or a positive HDV-RNA  test - Patients must be >=18 years and <= 70 years. - Non-cirrhotic or cirrhotic compensated liver disease - Patients must be able to provie a written informed consent

Exclusion criteria

Exclusion criteria: • Clinical decompensated cirrhosis (Child-Pugh Grade B or C). • Hepatic imaging (ultrasound, CT or MRI) with evidence of hepatocellular carcinoma. • Females who are pregnant or breast-feeding. • History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigators, unsuitable for the study. • Received prolonged therapy with immunomodulatory agents (e.g. corticosteroids) or biologics (e.g. monoclonal antibody, interferon) within 6 months of screening. • Thrombocytes

Design outcomes

Primary

MeasureTime frame
The immuno-phenotype of CD4+ T cells, CD8+ T cells, monocytes/macrophages, neutrophils, NK cells, NKT cells, MAIT cells, and B cells will be assessed in blood and liver of patients chronic HBV-HDV. The function of CD4+ T cells, CD8+ T cells, monocytes/macrophages, neutrophils, NK cells, NKT cells, MAIT cells, and B cells will be assessed in blood. Gene expression profiles of immune cells and hepatocytes in blood and liver of patients will be assessed.

Countries

Netherlands

Contacts

Public ContactE. Fath el Bab

Erasmus MC, Universitair Medisch Centrum Rotterdam

e.fathelbab@erasmusmc.nl0629677982

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026