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

NCT ID: NCT01062659

Last Updated: 2014-04-01

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-03-31

Brief Summary

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.

Conditions

Hepatitis C, Chronic; Liver Diseases; Virus Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

chronic Hepatitis C

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Dietmar M. Klass

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dietmar M Klass, MD

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Locations

University Hospital Ulm

Ulm, , Germany

Countries

Germany

Other Identifiers

TCell

Identifier Type: -

Identifier Source: org_study_id