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This is a Phase 2, multi-center, randomized, open-label study to evaluate the safety, tolerability, and efficacy of Albuferon in subjects with hepatitis C (HEP C) who failed to respond to previous interferon alfa therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuferon | Drug | |||
| Ribavirin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities. |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response (SVR), defined as undetectable virus at 24 weeks after the end of therapy. The primary efficacy assessment is HCV RNA level. |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| University of Florida CRC |
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| Gainesville |
| Florida |
| 32610 |
| United States |
| University of Florida at Jacksonville | Jacksonville | Florida | 32209 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32216 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| 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 |
|---|---|
| C473631 | albuferon |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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