Study Investigating Immunological Effects of Treatment for Chronic Hepatitis C Patients. (CIRES)
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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). |
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 |
Patients chronically infected with HCV-genotype 1,2 or 3
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| Netherlands | |
| Department of Gastroenterology & Hepatology, Erasmus Medical Center | |
| Rotterdam, Zuid-Holland, Netherlands, 3015 GD | |
| 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, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Interferons Ribavirin Peginterferon alfa-2b Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013