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| Sponsored by: |
University of Nebraska |
|---|---|
| Information provided by: | University of Nebraska |
| ClinicalTrials.gov Identifier: | NCT00876174 |
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: | Cohort, Prospective |
| Official Title: | Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C |
20 ml blood for peripheral mononuclear cells
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2009 |
| 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
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control
Group 2, (control): 10 healthy family members or significant others of patients who are to undergo standard antiviral therapy
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Procedure: Blood draw, 20ml peripheral blood mononuclear cells
One time blood draw of 20 ml
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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 |
Adults with genotype 1, chronic hepatitis C who are to undergo antiviral therapy and their healthy family member or significant other
Inclusion Criteria:
Controls:
Contacts and Locations| Contact: Mary E Capadano, BSN, RN | 402-559-3652 | mcapadano@unmc.edu |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| Principal Investigator: | Mark E Mailliard, MD | University of Nebraska |
More Information
| Responsible Party: | University of Nebraska Medical Center ( Mark E. Mailliard, M.D. ) |
| Study ID Numbers: | 143-09-EP |
| Study First Received: | April 2, 2009 |
| Last Updated: | April 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00876174 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Chronic hepatitis C Genotype 1 |
|
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Interferons Hepatitis, Viral, Human Hepatitis C Antiviral Agents Hepatitis C, Chronic |
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Virus Diseases Hepatitis RNA Virus Infections Liver Diseases Digestive System Diseases |
Flaviviridae Infections Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
