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Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

Information source: University of Nebraska
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C

Intervention: Blood sampling of peripheral blood mononuclear cells (Procedure); Blood draw, 20ml peripheral blood mononuclear cells (Procedure)

Phase: N/A

Status: Terminated

Sponsored by: University of Nebraska

Official(s) and/or principal investigator(s):
Mark E Mailliard, MD, Principal Investigator, Affiliation: University of Nebraska


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.

Clinical Details

Official title: Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: To investigate the prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment

Secondary outcome: To determine the effects of antiviral treatment on interferon gene signaling in 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.


Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: 1. 19 years of age or older, of either gender. 2. History of chronic hepatitis C as documented by HCVRNA. 3. . Documented genotype 1. 4. Subject prescribed antiviral therapy 5. Able to give informed consent. Controls: 1. Greater than 19 years of age. 2. Subject reports good general health. 3. Subject denies chronic hepatitis C infection. 4. Able to give informed consent.

Locations and Contacts

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States
Additional Information

Starting date: May 2009
Last updated: January 11, 2010

Page last updated: August 20, 2015

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