Hepatitis C Clinical Trial
— CIRESOfficial 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).
| Verified date | January 2017 |
| Source | Foundation for Liver Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | November 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Department of Gastroenterology & Hepatology, Erasmus Medical Center | Rotterdam | Zuid-Holland |
| Lead Sponsor | Collaborator |
|---|---|
| Foundation for Liver Research |
Netherlands,
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