Cellular Immune Responses in the Liver in Chronic Hepatitis C (CHC) Patients
This study has been withdrawn prior to enrollment.
(Lack of funding)
Sponsor:
University of Ulm
Information provided by (Responsible Party):
Dietmar M. Klass, University of Ulm
ClinicalTrials.gov Identifier:
NCT01062659
First received: February 3, 2010
Last updated: March 31, 2014
Last verified: March 2014
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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:
Further study details as provided by 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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01062659
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | February 3, 2010 |
| Last Updated: | March 31, 2014 |
| 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:
|
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 |
ClinicalTrials.gov processed this record on September 23, 2016