Cellular Immune Responses in the Liver in Chronic Hepatitis C (CHC) Patients

March 31, 2014 updated by: Dietmar M. Klass, University of Ulm

Characterization of Cellular Immune Responses in the Liver in Patients With Chronic Hepatitis C Virus Infection

In order to persist in the liver, HCV has numerous nonspecific and specific strategies to overcome the immunity of the host. The crucial step in the establishment of viral persistence and chronic hepatitis is the avoidance of specific antiviral cellular immune response in the liver. Treatment with pegylated interferon alpha (IFNα) in combination with ribavirin (RBV) is the standard therapy for chronic hepatitis C is. The response to IFNα / RBV therapy depends on the effective cellular antiviral immune response in the liver. The understanding of the interaction between HCV and cellular immune response is important for the effective use of existing diagnostic techniques, the Individual control and adjustment of the current therapeutic approaches and the development of future therapeutic and immunization strategies. In this study, the investigators want to investigate cellular Immune responses in the liver of HCV infected patients and characterize the influence of these immune responses to the response to IFNα / RBV therapy.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

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

  • Germany
      • Ulm, Germany
        • University Hospital Ulm

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patient with established chronic hepatitis C presented to the liver unit of the outpatient clinic how are eligible to antiviral therapy.

Description

Inclusion Criteria:

  • proven chronic hepatitis C
  • aged between 18 and 65
  • willingness to give written informed consent to the study protocol

Exclusion Criteria:

  • history of having received any IFN, PEG-IFN or RBV
  • not eligible for antiviral treatment with peginterferon and ribavirin by standard of care

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
chronic Hepatitis C
Patients with chronic Hepatitis C (CHC) Genotype 1-4 who are naive to antiviral treatment

Collaborators and Investigators

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

Sponsor

University of Ulm

Investigators

  • Principal Investigator: Dietmar M Klass, MD, University of Ulm

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

February 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

March 1, 2013

Study Registration Dates

First Submitted

February 3, 2010

First Submitted That Met QC Criteria

February 3, 2010

First Posted (ESTIMATE)

February 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 1, 2014

Last Update Submitted That Met QC Criteria

March 31, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCell

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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