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no accrual
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling of peripheral blood mononuclear cells | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells | To determine the effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells | 3 years |
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Inclusion Criteria
Exclusion Criteria
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Adults with genotype 1, chronic hepatitis C who are to undergo antiviral therapy and their healthy family member or significant other
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| Name | Affiliation | Role |
|---|---|---|
| Mark E Mailliard, MD | University of Nebraska | Principal Investigator |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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20 ml blood for peripheral mononuclear cells
| Blood draw, 20ml peripheral blood mononuclear cells | Procedure | One time blood draw of 20 ml |
|
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |