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

NCT00422838 | Completed

• 1 other identifier: CIRES
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; Liver; Immunology; Regulation

Keywords

Hepatitis C; Liver; immunology; regulation; Genotype 1,2,3; Treatment; Chronic; Pegylated interferon; Ribavirin

Study Arms (2)

1

Chronic HCV Genotype 1 monoinfection, never had interferon and ribavirin treatment

Procedure: fine-needle aspiration biopsy

2

Chronic HCV Genotype 2 or 3 monoinfection,never had interferon and ribavirin treatment

Procedure: fine-needle aspiration biopsy

Interventions

fine-needle aspiration biopsy PROCEDURE

aspiration of intrahepatic cells

1; 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation for Liver Research: lead

Study Sites (1)

Department of Gastroenterology & Hepatology, Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Related Links

• website of the Erasmus Medical Center Rotterdam
• website of the Department of Gastroenterology \& Hepatology - Erasmus Medical Center Rotterdam

Biospecimen

Retention: SAMPLES WITH DNA

PBMC Serum RNA Liver infiltrating lymphocytes

MeSH Terms

Conditions

Hepatitis C; Bronchiolitis Obliterans Syndrome

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2007
• First Posted: January 17, 2007
• Study Start: January 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

NL (1)