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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Ulm.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT01062659
First received: February 3, 2010
Last updated: March 1, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition
Hepatitis C, Chronic
Liver Diseases
Virus Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Cellular Immune Responses in the Liver in Patients With Chronic Hepatitis C Virus Infection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Ulm:

Estimated Enrollment: 60
Study Start Date: February 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
chronic Hepatitis C
Patients with chronic Hepatitis C (CHC) Genotype 1-4 who are naive to antiviral treatment

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062659

Contacts
Contact: Dietmar M Klass, MD +49-731-500 ext 44726 dietmar.klass@uniklinik-ulm.de
Contact: Simone Bader +49-731-500 ext 44609 simone.bader@uniklinik-ulm.de

Locations
Germany
University Hospital Ulm Recruiting
Ulm, Germany
Contact: Dietmar M Klass, MD     +49-731-500 ext 44726     dietmar.klass@uniklinik-ulm.de    
Principal Investigator: Dietmar M Klass, MD            
Sub-Investigator: Richard Lorenz, MD            
Sub-Investigator: Eugen Zizer, MD            
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Dietmar M Klass, MD Ulm University
  More Information

No publications provided

Responsible Party: Dr. med. Dietmar M. Klass, Universitätsklinikum Ulm
ClinicalTrials.gov Identifier: NCT01062659     History of Changes
Other Study ID Numbers: TCell
Study First Received: February 3, 2010
Last Updated: March 1, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Ulm:
HCV
hepatitis C virus
CHC
chronic hepatitis c
interferon
 ribavirin
Hepatitis, Viral, Human
Anti-Infective Agents
peginterferon alfa-2a
peginterferon alfa-2b

Additional relevant MeSH terms:
Virus Diseases
RNA Virus Infections
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Diseases
Hepatitis C, Chronic
Digestive System Diseases
 Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Peginterferon alfa-2b
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents

ClinicalTrials.gov processed this record on May 19, 2013