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The purpose of this research study is to find out the effect of the investigational drug NOV-205 on the level of hepatitis C virus in the blood and whether NOV-205 is well-tolerated at different doses when taken by subjects with hepatitis C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single | Experimental | single-arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOV-205 | Drug | There will be 4 treatment Groups with 10 patients in each group:
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate changes in viral load | 16 months | |
| To evaluate changes in serum ALT and AST levels | 16 months | |
| To evaluate the durability of any changes in viral load and serum ALT and AST | 16 months | |
| To establish the safety profile of NOV-205 | 16 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Koff, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Borland-Grooover Clinic | Jacksonville | Florida | 32256 | United States | ||
| Venture Research Institute, LLC |
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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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|
| Miami |
| Florida |
| 33162 |
| United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| MetroWest Medical Center | Framingham | Massachusetts | 01702 | United States |
| UMASS Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | 28304 | United States |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |