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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

February 3, 2010
March 1, 2010
February 2010
December 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01062659 on ClinicalTrials.gov Archive Site
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Cellular Immune Responses in the Liver in Chronic Hepatitis C (CHC) Patients
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

All patient with established chronic hepatitis C presented to the liver unit of the outpatient clinic how are eligible to antiviral therapy.
  • Hepatitis C, Chronic
  • Liver Diseases
  • Virus Diseases
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chronic Hepatitis C
Patients with chronic Hepatitis C (CHC) Genotype 1-4 who are naive to antiviral treatment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
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
Germany
 
NCT01062659
TCell
No
Dr. med. Dietmar M. Klass, Universitätsklinikum Ulm
University of Ulm
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Principal Investigator: Dietmar M Klass, MD Ulm University
University of Ulm
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP