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Longitudinal Characterization of Intrahepatic Immune Responses and Gene Expression Profiles in Patients with Viral Hepatitis. An investigator initiated single centre study.

Longitudinal Characterization of Intrahepatic Immune Responses and Gene Expression Profiles in Patients with Viral Hepatitis. An investigator initiated single centre study. - Longitudinal characterization of viral hepatitis patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45711
Enrollment
50
Registered
2017-01-26
Start date
2017-01-02
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

chronic hepatitis B. chronic hepatitis C

Interventions

Per time point max. 50 ml of peripheral blood and fine needle aspirate biopsies will be collected.

Sponsors

Stichting Leveronderzoek
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Diagnosed with chronic HCV or chronic HBV * Hepatitis C viral RNA detectable in case of chronic HCV infection or HBsAg positive for over 6 months in case of chronic HBV infection. * Non-cirrhotic compensated liver disease. * Age * 18 years and * 70 years. * Written informed consent.

Exclusion criteria

Exclusion criteria: * Extensive bridging fibrosis indicated by histology (gold standard), imaging, transient elastography or 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.

Design outcomes

Primary

MeasureTime frame
To evaluate the functionality of immune cells in the liver and blood in chronic HCV and chronic HBV patients before, and during or after treatment with antiviral treatment, as well as their gene expression profiles.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)