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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT00422838
First received: January 15, 2007
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Hepatitis C
Liver
Immunology
Regulation
Procedure: fine-needle aspiration biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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).

Resource links provided by NLM:


Further study details as provided by Foundation for Liver Research:

Biospecimen Retention:   Samples With DNA

PBMC Serum RNA Liver infiltrating lymphocytes


Estimated Enrollment: 27
Study Start Date: January 2007
Study Completion Date: November 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Chronic HCV Genotype 1 monoinfection, never had interferon and ribavirin treatment
Procedure: fine-needle aspiration biopsy
aspiration of intrahepatic cells
2
Chronic HCV Genotype 2 or 3 monoinfection,never had interferon and ribavirin treatment
Procedure: fine-needle aspiration biopsy
aspiration of intrahepatic cells

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients chronically infected with HCV-genotype 1,2 or 3

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422838

Locations
Netherlands
Department of Gastroenterology & Hepatology, Erasmus Medical Center
Rotterdam, Zuid-Holland, Netherlands, 3015 GD
Sponsors and Collaborators
Foundation for Liver Research
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Foundation for Liver Research
ClinicalTrials.gov Identifier: NCT00422838     History of Changes
Other Study ID Numbers: CIRES
Study First Received: January 15, 2007
Last Updated: September 6, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Foundation for Liver Research:
Hepatitis C
Liver
immunology\
regulation
Genotype 1,2,3
Treatment
Chronic
Pegylated interferon
Ribavirin

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014