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

NCT01062659 | Withdrawn

• 1 other identifier: TCell
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

HCV; hepatitis C virus; CHC; chronic hepatitis c; interferon; ribavirin; Hepatitis, Viral, Human; Anti-Infective Agents; peginterferon alfa-2a; peginterferon alfa-2b

Study Arms (1)

chronic Hepatitis C

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

University Hospital Ulm

Ulm, Germany

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Liver Diseases; Virus Diseases; Hepatitis C; Hepatitis, Viral, Human

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dietmar M Klass, MD

  University of Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: April 1, 2014

Record last verified: 2014-03

Locations

DE (1)