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| Name | Class |
|---|---|
| Tibotec Pharmaceutical Limited | INDUSTRY |
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Purpose:
The purpose of this exploratory study is to evaluate phosphoprotein profiling to determine differences in the intracellular actions of interferon or interferon stimulated genes among people with different treatment outcomes to interferon based therapy for hepatitis C (HCV). Participants: Patients with genotype 1 HCV who have had interferon based therapy at the University of North Carolina (UNC). Procedures: Thirty patients with varied responses to treatment will be given a single subcutaneous injection of interferon alpha 2b. Prior to the injection and at 30 minutes, 1,2,4,6,12 and 20 hours after injection, blood will be drawn for analysis of phosphoprotein profiling and changes in serum cytokines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interferon Alfa-2b | Experimental | Patients will receive a single dose of interferon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon Alfa-2b | Drug | Patients will receive a single dose of interferon followed by serial blood draws to assess cellular responses to interferon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Protein quantification of interferon stimulated genes (ISG) | This is an exploratory study observing downstream phosphorylation of interferon stimulated genes in the Janus Activated Kinase (JAK-STAT) pathway. | 0-20 hours |
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Inclusion Criteria:
To be eligible for this study, subjects must meet the following inclusion criteria:
Exclusion Criteria
Subjects with any of the following will not be eligible for participation:
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| Name | Affiliation | Role |
|---|---|---|
| Sid Barritt, MD, MSCR | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D000077190 | Interferon alpha-2 |
| D007438 | Introns |
| ID | Term |
|---|---|
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |