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

January 26, 2017 updated by: Foundation for Liver Research

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Department of Gastroenterology & Hepatology, Erasmus Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients chronically infected with HCV-genotype 1,2 or 3

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Chronic HCV Genotype 1 monoinfection, never had interferon and ribavirin treatment
Procedure: fine-needle aspiration biopsy
aspiration of intrahepatic cells
2
Chronic HCV Genotype 2 or 3 monoinfection,never had interferon and ribavirin treatment
Procedure: fine-needle aspiration biopsy
aspiration of intrahepatic cells

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Liver Research

Investigators

  • Principal Investigator: R.J. de Knegt, MD, PhD, Department of Gastroenterology & Hepatology - Erasmus Medical Center Rotterdam
  • Principal Investigator: H.L.A. Janssen, MD, PhD, Department of Gastroenterology & Hepatology - Erasmus Medical Center Rotterdam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

January 15, 2007

First Submitted That Met QC Criteria

January 15, 2007

First Posted (Estimate)

January 17, 2007

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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