Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

Sponsor

University of Nebraska (Other)

Overall Status

Terminated

CT.gov ID

NCT00876174

Collaborator

(none)

Enrollment

Location

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C	Procedure: Blood sampling of peripheral blood mononuclear cells Procedure: Blood draw, 20ml peripheral blood mononuclear cells

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 Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

Study Start Date :

May 1, 2009

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Patients

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

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

control

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

Procedure: Blood draw, 20ml peripheral blood mononuclear cells

One time blood draw of 20 ml

Outcome Measures

Primary Outcome Measures

To investigate the prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment [3 years]

Secondary Outcome Measures

To determine the effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

19 years of age or older, of either gender.
History of chronic hepatitis C as documented by HCVRNA.
. Documented genotype 1.
Subject prescribed antiviral therapy
Able to give informed consent.

Controls:

Greater than 19 years of age.
Subject reports good general health.
Subject denies chronic hepatitis C infection.
Able to give informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198

Sponsors and Collaborators

University of Nebraska

Investigators

Principal Investigator: Mark E Mailliard, MD, University of Nebraska

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00876174

Other Study ID Numbers:

143-09-EP

First Posted:

Apr 6, 2009

Last Update Posted:

Jan 12, 2010

Last Verified:

Jan 1, 2010

Keywords provided by , ,

Chronic hepatitis C

Genotype 1

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2010