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| Name | Class |
|---|---|
| Tibotec Pharmaceutical Limited | INDUSTRY |
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Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time |
| |
| Cohort B | Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telaprevir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who maintain undetectable HCV RNA over time after achieving an SVR following telaprevir-based treatment | 3 years | |
| Change in HCV variants with decreased sensitivity to telaprevir over time in subjects failing to achieve an SVR following telaprevir-based treatment | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HCV variants with decreased sensitivity to telaprevir over time in subjects with late relapse | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have previously received at least 1 dose of telaprevir-based treatment (telaprevir plus peginterferon alfa 2a [Peg IFN-alfa-2a] with or without ribavirin [RBV]) in 1 of the following clinical studies: VX05-950-104, VX05 950-104EU, VX06-950-106, VX06-950-107, VX07-950-108, VX08-950-111, and VX-950-TiDP24-C216.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama | Birmingham | Alabama | United States | |||
| California |
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| Coronado |
| California |
| United States |
| California | Los Angeles | California | United States |
| California | San Francisco | California | United States |
| Colorado | Denver | Colorado | United States |
| Colorado | Englewood | Colorado | United States |
| Florida | Gainsville | Florida | United States |
| Florida | Jacksonville | Florida | United States |
| Florida | Miami | Florida | United States |
| Georgia | Altanta | Georgia | United States |
| Maryland | Baltimore | Maryland | United States |
| Massachusetts | Boston | Massachusetts | United States |
| Michigan | Novi | Michigan | United States |
| Missouri | St Louis | Missouri | United States |
| New Mexico | Albuquerque | New Mexico | United States |
| New York | Manhasset | New York | United States |
| New York | New York | New York | United States |
| North Carolina | Chapel Hill | North Carolina | United States |
| North Carolina | Durham | North Carolina | United States |
| Ohio | Cincinnati | Ohio | United States |
| South Carolina | Columbia | South Carolina | United States |
| Texas | Houston | Texas | United States |
| Texas | San Antonio | Texas | United States |
| Virginia | Fairfax | Virginia | United States |
| Virginia | Falls Church | Virginia | United States |
| Canada | Vancouver | British Columbia | Canada |
| Canada | Toronto | Ontario | Canada |
| France | Clichy | France |
| France | Marseille | France |
| France | Paris | France |
| France | Pessac | France |
| France | Vandœuvre-lès-Nancy | France |
| Germany | Berlin | Germany |
| Germany | Cologne | Germany |
| Germany | Frankfurt | Germany |
| Germany | Freiburg im Breisgau | Germany |
| Germany | Hamburg | Germany |
| Germany | Hanover | Germany |
| Germany | Munich | Germany |
| Germany | Wien | Germany |
| Puerto Rico | Santurce | Puerto Rico |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C486464 | telaprevir |
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