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

This study has been withdrawn prior to enrollment.

(Lack of funding)

Sponsor:

ClinicalTrials.gov Identifier:

NCT01062659

First Posted: February 4, 2010

Last Update Posted: April 1, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Dietmar M. Klass, University of Ulm

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

U.S. FDA Resources

Further study details as provided by Dietmar M. Klass, University of Ulm:


Enrollment:	0
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

Information from the National Library of Medicine

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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

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


Responsible Party:	Dietmar M. Klass, Dr. med., University of Ulm
ClinicalTrials.gov Identifier:	NCT01062659 History of Changes
Other Study ID Numbers:	TCell
First Submitted:	February 3, 2010
First Posted:	February 4, 2010
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

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