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

Completed

• Conditions: Hepatitis C; Immunology; Regulation; Liver
• Interventions: Procedure: fine-needle aspiration biopsy

• Registration Number: NCT00422838
• Lead Sponsor: Foundation for Liver Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-15
• Study First Submitted QC: 2007-01-15
• Study First Posted: 2007-01-17
• Primary Completion: 2010-06
• Study Completion: 2010-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	fine-needle aspiration biopsy	Chronic HCV Genotype 1 monoinfection, never had interferon and ribavirin treatment
2	fine-needle aspiration biopsy	Chronic HCV Genotype 2 or 3 monoinfection,never had interferon and ribavirin treatment

Trial Locations

Locations (1)

Department of Gastroenterology & Hepatology, Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands