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Study Investigating Immunological Effects of Treatment for Chronic Hepatitis C Patients. (CIRES)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00422838
First Posted: January 17, 2007
Last Update Posted: January 27, 2017
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):
Foundation for Liver Research
January 15, 2007
January 17, 2007
January 27, 2017
January 2007
June 2010   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00422838 on ClinicalTrials.gov Archive Site
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Study Investigating Immunological Effects of Treatment for Chronic Hepatitis C Patients.
Impact of Immune Responses in Chronic Hepatitis C Genotype 1,2,3 Virus Infected Patients During Treatment With Pegylated Interferon-alpha-2b and Ribavirin (CIRES).

Aim

To evaluate the effects of peginterferon and ribavirin therapy on the immune response in chronic HCV genotype 1,2 or 3 patients before, during and after treatment.

Background

Treatment of chronic hepatitis C (HCV) has shown a remarkable success. However, genotype 1 patients have reduced response rates. A better understanding and improvement of these results can now be considered the greatest challenge.

In chronically infected patients, HCV-specific immune responses are generally weak, narrowly focused, and often dysfunctional. The presence of HCV-specific cells suppressing the immune response (regulatory T-lymphocytes=Treg) are able to suppress the immune response. These Treg are possibly responsible for the impaired immune response.

Previous studies have indicated increased Treg frequency and activity of immune regulating mechanisms, locally in the liver, as a result of HCV re-infection. Hence, these Data highlight the importance of monitoring intrahepatic immune responses in addition to peripheral immune responses. Using the minimally-invasive technique of fine-needle aspiration biopsy (FNAB), it is now possible to obtain safe and frequent liver samples to monitor local antiviral immune responses in chronic HCV patients during antiviral therapy.

Rationale and hypothesis of the study

Our previous studies and current literature support the concept that Treg may contribute to HCV persistence by suppressing HCV-spec immune responses. The current study is designed to examine if peginterferon and ribavirin therapy affects the activity of Treg and DC, and if this results in enhanced HCV-specific immune responses.

Design

Single centre, translational and observational open label study with one arm of 20 genotype 1 patients and one arm of 7 genotype 2/3 patients.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
PBMC Serum RNA Liver infiltrating lymphocytes
Non-Probability Sample
Patients chronically infected with HCV-genotype 1,2 or 3
  • Hepatitis C
  • Liver
  • Immunology
  • Regulation
Procedure: fine-needle aspiration biopsy
aspiration of intrahepatic cells
  • 1
    Chronic HCV Genotype 1 monoinfection, never had interferon and ribavirin treatment
    Intervention: Procedure: fine-needle aspiration biopsy
  • 2
    Chronic HCV Genotype 2 or 3 monoinfection,never had interferon and ribavirin treatment
    Intervention: Procedure: fine-needle aspiration biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female patients between 18-70 years of age, with evidence of a chronic hepatitis C - Genotype 1,2 or 3 infection.
  • No previous treatment with, peginterferon or conventional interferon plus ribavirin combination therapy.
  • Indication for antiviral therapy of hepatitis C according to current clinical guidelines.
  • Written informed consent.

Exclusion Criteria:

  • History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigators, unsuitable for the study.
  • Presence of contra-indications for antiviral therapy with peginterferon or ribavirin.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00422838
CIRES
No
Not Provided
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Foundation for Liver Research
Foundation for Liver Research
Not Provided
Principal Investigator: R.J. de Knegt, MD, PhD Department of Gastroenterology & Hepatology - Erasmus Medical Center Rotterdam
Principal Investigator: H.L.A. Janssen, MD, PhD Department of Gastroenterology & Hepatology - Erasmus Medical Center Rotterdam
Foundation for Liver Research
January 2017