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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of the study is to determine differences in levels of serum chemokines from patients undergoing treatment with Boceprevir. The aim is to determine if non-responders have significantly different levels of chemokines than responders.
Patients undergoing standard of care at the UNC Liver Center are consented for collection of an additional serum sample under the UNC Liver Center serum and tissue bank study. These samples will be used to analyze differences in serum chemokines across responders and non-responders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sustained virological response | Patients who achieve sustained virological response (SVR) are defined as undetectable HCV RNA in serum obtained 12 weeks or beyond the end of antiviral therapy. | ||
| Non-responders | Non-responders are defined as patients who have not achieved virological milestones during therapy or who have relapsed with detectable HCV RNA in serum after cessation of treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Level (ng/mL) of serum chemokines. | Compare levels of serum chemokines across Boceprevir responders (SVR) and non-responders for both Baseline (<=6-months pre-treatment) and Post-treatment (<=6-months post-treatment). | Baseline: <=6 months prior to start of treatment and Post-treatment: <=6-months after the last dose |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female adult patients: Aged 18 and older with chronic HCV treated with triple therapy (including Boceprevir).
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| Name | Affiliation | Role |
|---|---|---|
| Michael W Fried, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Liver Center | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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Serum and tissue collected through the UNC Liver Center serum and tissue bank.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |