Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

Withdrawn

• Conditions: Chronic Hepatitis C
• Interventions: Procedure: Blood sampling of peripheral blood mononuclear cells; Procedure: Blood draw, 20ml peripheral blood mononuclear cells

• Registration Number: NCT00876174
• Lead Sponsor: University of Nebraska

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Study Start: 2009-04-15
• Primary Completion: 2010-01-08
• Study Completion: 2010-01-08
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Blood sampling of peripheral blood mononuclear cells	20 patients with genotype 1, chronic hepatitis C who are to undergo standard antiviral therapy
control	Blood draw, 20ml peripheral blood mononuclear cells	Group 2, (control): 10 healthy family members or significant others of patients who are to undergo standard antiviral therapy

Primary Outcome Measures

Name	Time	Method
Prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment	3 years	To investigate the prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment

Secondary Outcome Measures

Name	Time	Method
Effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells	3 years	To determine the effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells