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Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

This study has been terminated.
(no accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00876174
First Posted: April 6, 2009
Last Update Posted: January 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Nebraska
April 2, 2009
April 6, 2009
January 12, 2010
May 2009
Not Provided
To investigate the prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT00876174 on ClinicalTrials.gov Archive Site
To determine the effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells [ Time Frame: 3 years ]
Same as current
Not Provided
Not Provided
 
Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C
Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
20 ml blood for peripheral mononuclear cells
Non-Probability Sample
Adults with genotype 1, chronic hepatitis C who are to undergo antiviral therapy and their healthy family member or significant other
Chronic Hepatitis C
  • 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
  • Procedure: Blood draw, 20ml peripheral blood mononuclear cells
    One time blood draw of 20 ml
  • Patients
    20 patients with genotype 1, chronic hepatitis C who are to undergo standard antiviral therapy
    Intervention: Procedure: Blood sampling of peripheral blood mononuclear cells
  • control
    Group 2, (control): 10 healthy family members or significant others of patients who are to undergo standard antiviral therapy
    Intervention: Procedure: Blood draw, 20ml peripheral blood mononuclear cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
January 2010
Not Provided

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.
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00876174
143-09-EP
No
Not Provided
Not Provided
Mark E. Mailliard, M.D., University of Nebraska Medical Center
University of Nebraska
Not Provided
Principal Investigator: Mark E Mailliard, MD University of Nebraska
University of Nebraska
January 2010