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

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ClinicalTrials.gov Identifier: NCT01062659
Recruitment Status : Withdrawn (Lack of funding)
First Posted : February 4, 2010
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):
Dietmar M. Klass, University of Ulm

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Hepatitis C, Chronic Liver Diseases Virus Diseases

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Cellular Immune Responses in the Liver in Patients With Chronic Hepatitis C Virus Infection
Study Start Date : February 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062659


Locations
Germany
University Hospital Ulm
Ulm, Germany
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Dietmar M Klass, MD University of Ulm
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dietmar M. Klass, Dr. med., University of Ulm
ClinicalTrials.gov Identifier: NCT01062659     History of Changes
Other Study ID Numbers: TCell
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: March 2014

Keywords provided by Dietmar M. Klass, 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:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Virus Diseases
 Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections