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This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEGASYS with COPEGUS | Active Comparator |
| |
| RO5024048 1500mg in combination with PEGASYS | Experimental |
| |
| RO5024048 3000mg in combination with PEGASYS | Experimental |
| |
| RO5024048 in combination with PEGASYS and COPEGUS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copegus | Drug | 1000/1200mg po daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) and laboratory parameters. | Week 4, 8 and Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of HCV polymerase inhibitor | Week 4 and 8 | |
| Antiviral activity | Week 4, 8 and Week 72 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Jolla | California | 92037-1030 | United States | |||
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| PEGASYS | Drug | 180 micrograms sc weekly for 4 weeks |
|
| RO5024048 1500mg | Drug | 1500mg po bid for 4 weeks |
|
| RO5024048 3000mg | Drug | 3000mg po bid for 4 weeks |
|
| Long Beach |
| California |
| 90822 |
| United States |
| Sacramento | California | 95817 | United States |
| San Diego | California | 92103-8465 | United States |
| San Diego | California | 92154 | United States |
| San Francisco | California | 94115 | United States |
| Aurora | Colorado | 80045 | United States |
| Bradenton | Florida | 34209 | United States |
| Gainesville | Florida | 32610-0214 | United States |
| Chicago | Illinois | 60637 | United States |
| Novi | Michigan | 48377 | United States |
| Manhasset | New York | 11030 | United States |
| New York | New York | 10029 | United States |
| Chapel Hill | North Carolina | 27599-7584 | United States |
| Dallas | Texas | 75203 | United States |
| Fort Sam Houston | Texas | 78234-3879 | United States |
| Richmond | Virginia | 23249 | United States |
| Santurce | 00909 | Puerto Rico |
| 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 |
|---|---|
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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