Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

August 11, 2023 updated by: 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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment
Time Frame: 3 years
To investigate the prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells
Time Frame: 3 years
To determine the effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2009

Primary Completion (Actual)

January 8, 2010

Study Completion (Actual)

January 8, 2010

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 3, 2009

First Posted (Estimated)

April 6, 2009

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0143-09-EP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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