Study Investigating Immunological Effects of Treatment for Chronic Hepatitis C Patients.

Impact of Immune Responses in Chronic Hepatitis C Genotype 1,2,3 Virus Infected Patients During Treatment With Pegylated Interferon-alpha-2b and Ribavirin (CIRES).

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00422838

Acronym

CIRES

Enrollment

Registered

2007-01-17

Start date

2007-01-31

Completion date

2010-11-30

Last updated

2017-01-27

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

Conditions

Hepatitis C, Immunology, Liver, Regulation

Keywords

Hepatitis C, Liver, immunology, regulation, Genotype 1,2,3, Treatment, Chronic, Pegylated interferon, Ribavirin

Brief summary

Aim To evaluate the effects of peginterferon and ribavirin therapy on the immune response in chronic HCV genotype 1,2 or 3 patients before, during and after treatment. Background Treatment of chronic hepatitis C (HCV) has shown a remarkable success. However, genotype 1 patients have reduced response rates. A better understanding and improvement of these results can now be considered the greatest challenge. In chronically infected patients, HCV-specific immune responses are generally weak, narrowly focused, and often dysfunctional. The presence of HCV-specific cells suppressing the immune response (regulatory T-lymphocytes=Treg) are able to suppress the immune response. These Treg are possibly responsible for the impaired immune response. Previous studies have indicated increased Treg frequency and activity of immune regulating mechanisms, locally in the liver, as a result of HCV re-infection. Hence, these Data highlight the importance of monitoring intrahepatic immune responses in addition to peripheral immune responses. Using the minimally-invasive technique of fine-needle aspiration biopsy (FNAB), it is now possible to obtain safe and frequent liver samples to monitor local antiviral immune responses in chronic HCV patients during antiviral therapy. Rationale and hypothesis of the study Our previous studies and current literature support the concept that Treg may contribute to HCV persistence by suppressing HCV-spec immune responses. The current study is designed to examine if peginterferon and ribavirin therapy affects the activity of Treg and DC, and if this results in enhanced HCV-specific immune responses. Design Single centre, translational and observational open label study with one arm of 20 genotype 1 patients and one arm of 7 genotype 2/3 patients.

Interventions

PROCEDUREfine-needle aspiration biopsy

aspiration of intrahepatic cells

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Male and female patients between 18-70 years of age, with evidence of a chronic hepatitis C - Genotype 1,2 or 3 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 investigators, unsuitable for the study. * Presence of contra-indications for antiviral therapy with peginterferon or ribavirin.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026