Study Stopped
no accrual
Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C
1 other identifier
observational
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2009
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2009
CompletedFirst Posted
Study publicly available on registry
April 6, 2009
CompletedStudy Start
First participant enrolled
April 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2010
CompletedAugust 16, 2023
August 1, 2023
9 months
April 2, 2009
August 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment
To investigate the prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment
3 years
Secondary Outcomes (1)
Effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells
3 years
Study Arms (2)
Patients
20 patients with genotype 1, chronic hepatitis C who are to undergo standard antiviral therapy
control
Group 2, (control): 10 healthy family members or significant others of patients who are to undergo standard antiviral therapy
Interventions
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
Eligibility Criteria
Adults with genotype 1, chronic hepatitis C who are to undergo antiviral therapy and their healthy family member or significant other
You may qualify if:
- 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
You may not qualify if:
- Under 19 years of age
- Unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
20 ml blood for peripheral mononuclear cells
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark E Mailliard, MD
University of Nebraska
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2009
First Posted
April 6, 2009
Study Start
April 15, 2009
Primary Completion
January 8, 2010
Study Completion
January 8, 2010
Last Updated
August 16, 2023
Record last verified: 2023-08