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| Name | Class |
|---|---|
| Idun Pharmaceuticals | INDUSTRY |
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The purpose of this study is to determine if IDN-6556, when given orally, is safe and effective in patients with chronic hepatitis C virus infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| IDN-6556 5 mg twice a day (BID) | Active Comparator |
| |
| IDN-6556 25mg twice a day (BID) | Active Comparator |
| |
| IDN-6556 50 mg twice a day (BID) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDN-6556 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Median absolute change in aspartate transaminase (AST) values measured from baseline to Week 10 | ||
| Median absolute change in alanine aminotransferase (ALT) values measured from baseline to Week 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | United States | ||
| Scripps Clinic |
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| Placebo |
| Drug |
|
| La Jolla |
| California |
| 92067 |
| United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| Beth Israel Deaconness Medical Center | Boston | Massachusetts | 02215 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| The Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Mt. Sinai School of Medicine | New York | New York | 10029 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27715 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Metrohealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Medical College of Virginia | Richmond | Virginia | 23298 | United States |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| C487112 | 3-(2-(2-tert-butylphenylaminooxalyl)aminopropionylamino)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid |
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