Text Size

Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

This study has been terminated.
(no accrual)
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00876174
First received: April 2, 2009
Last updated: January 11, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Intervention
Chronic Hepatitis C
 Procedure: Blood sampling of peripheral blood mononuclear cells
Procedure: Blood draw, 20ml peripheral blood mononuclear cells

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • To investigate the prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

20 ml blood for peripheral mononuclear cells


Estimated Enrollment: 30
Study Start Date: May 2009
Study Completion Date: January 2010
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adults with genotype 1, chronic hepatitis C who are to undergo antiviral therapy and their healthy family member or significant other

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876174

Locations
United States, Nebraska
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
  More Information

No publications provided

Responsible Party: Mark E. Mailliard, M.D., University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00876174     History of Changes
Other Study ID Numbers: 143-09-EP
Study First Received: April 2, 2009
Last Updated: January 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Chronic hepatitis C
Genotype 1

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Interferons
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013