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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01062659
Other study ID # TCell
Secondary ID
Status Withdrawn
Phase N/A
First received February 3, 2010
Last updated March 31, 2014
Start date February 2010
Est. completion date March 2013

Study information

Verified date March 2014
Source University of Ulm
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Germany University Hospital Ulm Ulm

Sponsors (1)

Lead Sponsor Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

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