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To evaluate the safety and tolerability of two different doses of Consensus Interferon-Alpha and Interferon Gamma-1b with or without ribavirin in patients with chronic hepatitis C who are non-responders to PEG-IFN-a 2a or PEG-IFN-a 2b plus ribavirin.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin | Drug | interferon gamma-1b: 0.25 and 0.5 mL, SQ, 3x per week interferon alfacon: 0.3 mL and 0.5 mL, SQ, once a day Ribavirin: 2 capsules in a.m., 3 capsules in p.m.; daily |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic response defined as >2 log (base 10) reduction in HCV RNA | 72 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew McClure, MD | InterMune | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InterMune, Inc. | Brisbane | California | 94005 | United States |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C554125 | interferon gamma-1b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| 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 |