Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-15

Study Completion Date

2010-01-08

Brief Summary

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The objective of this pilot project is to investigate the prognostic criteria for sensitivity of Chronic Hepatitis C (CHC) Genotype 1, patients to IFNa treatment. Signal transduction in peripheral blood mononuclear cell (PBMC) of control groups will be compared with that of CHC patients. For this study, 20 patients with Hepatitis C virus (HCV) infection who are to undergo standard antiviral therapy and 10 healthy donors (significant others of the HCV subject) will be enrolled. Signal transduction will be studied in peripheral blood of CHC subjects before the treatment, after 1 and 3 months of treatment, and 4-6 months following the completion of treatment.

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Detailed Description

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In addition, the mechanism of non-responsiveness of HCV patients to IFNa will be studied. For this purpose, formation of complexes between STAT1 and its negative regulator, PIAS1 (immunoprecipitation, Western blot) will be examined. In comparing subjects on standard therapy vs the addition of betaine, (under separate studies) we will assess whether the formation of STAT1-PIAS1 complexes is due to impaired methylation on STAT1 on arginine residues which may be over come by the addition of betaine.

Conditions

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Chronic Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

20 patients with genotype 1, chronic hepatitis C who are to undergo standard antiviral therapy

Blood sampling of peripheral blood mononuclear cells

Intervention Type PROCEDURE

Group 1, (Patients): PMBC (20 ml blood) to be drawn at baseline, weeks 4 and 12 during antiviral therapy and 24 weeks following the end of antiviral therapy

control

Group 2, (control): 10 healthy family members or significant others of patients who are to undergo standard antiviral therapy

Blood draw, 20ml peripheral blood mononuclear cells

Intervention Type PROCEDURE

One time blood draw of 20 ml

Interventions

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Blood sampling of peripheral blood mononuclear cells

Group 1, (Patients): PMBC (20 ml blood) to be drawn at baseline, weeks 4 and 12 during antiviral therapy and 24 weeks following the end of antiviral therapy

Intervention Type PROCEDURE

Blood draw, 20ml peripheral blood mononuclear cells

One time blood draw of 20 ml

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 19 years of age or older, of either gender
* History of chronic hepatitis C documented by HCVRNA or healthy family member/significant other
* Documented genotype 1 for hepatitis participants or no hepatitis infection for healthy control
* Subject prescribed antiviral therapy for hepatitis participants or none for healthy control
* Able to give informed consent