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This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: With RO5024048 | Experimental | Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). |
|
| Arm B: Standard treatment | Active Comparator | Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5024048 | Drug | 1000mg bid po, 24 weeks |
| |
| Ribavirin [Copegus] |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test) | 24 weeks after last treatment dose |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic response over time | weeks 4, 12, 24, 36, 48 and 60 | |
| Pharmacokinetics of RO4995855 when RO5024048 is administered with peginterferon alfa-2a and ribavirin | week 12 and 24 | |
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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 | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24154738 | Derived | Tong X, Le Pogam S, Li L, Haines K, Piso K, Baronas V, Yan JM, So SS, Klumpp K, Najera I. In vivo emergence of a novel mutant L159F/L320F in the NS5B polymerase confers low-level resistance to the HCV polymerase inhibitors mericitabine and sofosbuvir. J Infect Dis. 2014 Mar 1;209(5):668-75. doi: 10.1093/infdis/jit562. Epub 2013 Oct 23. |
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| Drug |
1000mg or 1200mg po daily |
|
| peginterferon alfa-2a [Pegasys] | Drug | 180mcg sc weekly |
|
| Resistance profile of RO5024048 |
| weeks 1-24 |
| Bradenton |
| Florida |
| 34209 |
| United States |
| Atlanta | Georgia | 30309 | United States |
| Honolulu | Hawaii | 96813 | United States |
| Honolulu | Hawaii | 96817 | United States |
| Chicago | Illinois | 60637 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Kansas City | Kansas | 66160 | United States |
| Kansas City | Missouri | 64131 | United States |
| Lebanon | New Hampshire | 03756 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| New York | New York | 10003 | United States |
| New York | New York | 10021 | United States |
| The Bronx | New York | 10468 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Columbia | South Carolina | 29204 | United States |
| Nashville | Tennessee | 37232 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78234 | United States |
| Calgary | Alberta | T2N 4Z6 | Canada |
| Vancouver | British Columbia | V5Z 1H2 | Canada |
| Vancouver | British Columbia | V6Z 2K5 | Canada |
| Winnipeg | Manitoba | R3A 1R9 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| 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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