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This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1000 po bid) plus PEGASYS (180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). |
|
| Group 2 | Experimental | Group 2 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (500 mg po bid) plus PEGASYS (180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). |
|
| Group 3 | Experimental | Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. |
|
| Group 4 | Experimental | Group 4 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1500 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copegus | Drug | 1000/1200mg po daily for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response (SVR) | 24 weeks post treatment end (ie weeks 48 or 72) |
| Measure | Description | Time Frame |
|---|---|---|
| Virological response over time | Throughout study | |
| SVR | 12 weeks post treatment end (ie weeks 36 or 60) | |
| Relapse rate |
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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 |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85054 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22166557 | Derived | Nelson DR, Zeuzem S, Andreone P, Ferenci P, Herring R, Jensen DM, Marcellin P, Pockros PJ, Rodriguez-Torres M, Rossaro L, Rustgi VK, Sepe T, Sulkowski M, Thomason IR, Yoshida EM, Chan A, Hill G. Balapiravir plus peginterferon alfa-2a (40KD)/ribavirin in a randomized trial of hepatitis C genotype 1 patients. Ann Hepatol. 2012 Jan-Feb;11(1):15-31. |
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|
| Group 5 | Experimental | Group 5 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1000 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). |
|
| Group 6 | Experimental | Group 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (500 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). |
|
| Group 7 | Active Comparator | Standard of care (SOC) |
|
| Pegasys | Drug | 180 micrograms sc weekly for 24 weeks |
|
| Pegasys | Drug | 90 micrograms sc weekly for 24 weeks |
|
| RO4588161 | Drug | 1000mg po bid for 24 weeks |
|
| RO4588161 | Drug | 500mg po bid for 24 weeks |
|
| RO4588161 | Drug | 1500mg po bid for 24 weeks |
|
| End of treatment (ie weeks 24 or 48) |
| Adverse events (AEs), laboratory parameters. | Throughout treatment |
| La Jolla |
| California |
| 92037-1030 |
| United States |
| 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 |
| Englewood | Colorado | 80110 | United States |
| Bradenton | Florida | 34209 | United States |
| Gainesville | Florida | 32610-0214 | United States |
| Miami | Florida | 33136-1051 | United States |
| Chicago | Illinois | 60637 | United States |
| Baltimore | Maryland | 21287 | United States |
| Plymouth | Minnesota | 55446 | United States |
| Manhasset | New York | 11030 | United States |
| New York | New York | 10021 | United States |
| The Bronx | New York | 10468 | United States |
| Chapel Hill | North Carolina | 27599-7584 | United States |
| Cincinnati | Ohio | 45267-0595 | United States |
| Portland | Oregon | 97239 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Providence | Rhode Island | 02905 | United States |
| Nashville | Tennessee | 37211 | United States |
| Dallas | Texas | 75203 | United States |
| Fort Sam Houston | Texas | 78234-3879 | United States |
| San Antonio | Texas | 78215 | United States |
| Salt Lake City | Utah | 84121 | United States |
| Fairfax | Virginia | 22031 | United States |
| Richmond | Virginia | 23249 | United States |
| Adelaide | 5000 | Australia |
| Greenslopes | 4120 | Australia |
| Melbourne | 3004 | Australia |
| Sydney | 2050 | Australia |
| Sydney | 2145 | Australia |
| Vienna | 1090 | Austria |
| Calgary | Alberta | T2N 4N1 | Canada |
| Vancouver | British Columbia | V5Z 1H2 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M5G 1L7 | Canada |
| Clichy | 92118 | France |
| Créteil | 94010 | France |
| Marseille | 13285 | France |
| Paris | 75014 | France |
| Paris | 75651 | France |
| Pessac | 33604 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Berlin | 13353 | Germany |
| Cologne | 50937 | Germany |
| Frankfurt am Main | 60590 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Hamburg | 20246 | Germany |
| Hanover | 30625 | Germany |
| Bologna | 40138 | Italy |
| Naples | 80131 | Italy |
| Torino | 10126 | Italy |
| Santurce | 00909 | Puerto Rico |
| Badalona | 08915 | Spain |
| Barcelona | 08003 | Spain |
| Madrid | 28222 | Spain |
| Seville | 41014 | Spain |
| Valencia | 46014 | Spain |
| 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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