Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

Chronic Hepatitis C Clinical Trial

Official title:

Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00876174
• Other study ID #: 0143-09-EP
• Status: Withdrawn
• Start date: April 15, 2009
• Est. completion date: January 8, 2010

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 8, 2010
• Est. primary completion date: January 8, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Exclusion Criteria

• Under 19 years of age

• Unable to give informed consent

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Procedure:
• 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
• Blood draw, 20ml peripheral blood mononuclear cells
One time blood draw of 20 ml

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment	To investigate the prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment	3 years
Secondary	Effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells	To determine the effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells	3 years