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Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days.
This study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects with chronic Hepatitis C genotype 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Omega DUROS: Dose 25 |
|
| 2 | Experimental | Omega DUROS: Dose 50 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega DUROS device | Drug | Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| California Pacific Medical Center |
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| San Francisco |
| California |
| 94115 |
| United States |
| St. Louis University | St Louis | Missouri | 63110 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| The Liver Institute at Methodist Dallas | Dallas | Texas | 75203 | United States |
| Alamo Medical Research | San Antonio | Texas | 28215 | United States |
| Fundacion de Investigacion de Diego | San Juan | 00909 | Puerto Rico |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D012008 | Recurrence |
| 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 |
| 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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