Impact of Immune Responses in Chronic Hepatitis C Genotype 1 Virus Infected Patients during Treatment with Peg-Interferon-alpha-2b and Ribavirin.

Completed

• Conditions: 10047438; HCV; hepatitis C; 10019654; 10027665

• Registration Number: NL-OMON30088
• Lead Sponsor: Foundation for Liver Research (SLO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

-Male and female patients between 18-70 years of age, with evidence of a chronic hepatitis C Genotype 1 infection.
-No previous treatment with, peginterferon or conventional interferon plus ribavirin combination therapy.
-Indication for antiviral therapy of hepatitis C according to current clinical guidelines.
-Written informed consent.

Exclusion Criteria

•History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigator, unsuitable for the study.
•Presence of contra-indications for antiviral therapy with interferon or antiviral therapy.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Outcome measurements<br /><br><br /><br>Peripheral blood<br /><br>-Frequency, phenotype and function of HCV specific T cells.<br /><br>-Frequency, phenotype and function of Treg and DCs.<br /><br>-Determination of immunoregulatory cytokines in blood (Elispot or ELISA).<br /><br><br /><br>Intrahepatic<br /><br>-Frequency, phenotype and function of intrahepatic Treg.<br /><br>-Determination of immuneregulatory cytokines in the liver (Elispot or ELISA).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>No extra secundary outcome variables</p><br>