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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019585-90 |
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This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previous null responders (Cohort B): Group 4 | Experimental | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. |
|
| Previous null responders (Cohort B): Group 5 | Experimental | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 5 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. |
|
| Previous null responders (Cohort B): Group 6 | Experimental | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment. |
|
| Previous partial responders (Cohort A): Group 1 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copegus | Drug | 1000 mg or 1200 mg daily oral doses for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response (SVR) of danoprevir/ritonavir with RO5024048 and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment | 24 weeks | |
| Sustained virological response (SVR) of danoprevir/ritonavir with Pegasys and Copegus in patients with previous partial response to peginterferon/ribavirin treatment | 24 weeks | |
| Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment | 24 weeks | |
| Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus followed by 24 weeks of Pegasys and Copegus treatment in patients with previous null response to peginterferon/ribavirin treatment | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Incidence of adverse events) of danoprevir, RO5024048 and Copegus | 48 weeks | |
| Safety (Incidence of adverse events) of danoprevir, Pegasys and Copegus | 48 weeks | |
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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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Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 1 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
|
| Previous partial responders (Cohort A): Group 2 | Experimental | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. |
|
| Previous partial responders (Cohort A): Group 3 | Experimental | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 3 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. |
|
| Copegus | Drug | 1000 mg or 1200 mg daily oral doses for 48 weeks |
|
| Pegasys | Drug | 180 microgram subcutaneously once weekly for 24 weeks |
|
| Pegasys | Drug | 180 microgram subcutaneously once weekly for 48 weeks |
|
| RO5024048 | Drug | 1000 mg oral doses twice a day for 24 weeks |
|
| danoprevir | Drug | 100 mg oral doses twice a day for 24 weeks |
|
| ritonavir | Drug | 100 mg oral doses twice a day for 24 weeks |
|
| Safety (Incidence of adverse events) of danoprevir, RO5024048, Pegasys and Copegus |
| 72 weeks |
| Virological response over time | 48 weeks |
| Change in danoprevir plasma concentration | 24 weeks |
| Change in RO5024048 plasma concentration | 24 weeks |
| Hepatitis C virus drug resistance profile | 24 weeks |
| Long Beach |
| California |
| 90822 |
| United States |
| Sacramento | California | 95817 | United States |
| San Diego | California | 92103 | United States |
| Aurora | Colorado | 80045 | United States |
| Orlando | Florida | 32804 | United States |
| Decatur | Georgia | 30033 | United States |
| Chicago | Illinois | 60637 | United States |
| New Orleans | Louisiana | 70112 | United States |
| Detroit | Michigan | 48202-2689 | United States |
| Manhasset | New York | 11030 | United States |
| New York | New York | 10021 | United States |
| Chapel Hill | North Carolina | 27599-7584 | United States |
| Medford | Oregon | 97504 | United States |
| Providence | Rhode Island | 02905 | United States |
| Nashville | Tennessee | 37211 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78215 | United States |
| San Antonio | Texas | 78234 | United States |
| Darlinghurst | New South Wales | 2010 | Australia |
| Kingswood | New South Wales | 2747 | Australia |
| Westmead | New South Wales | 2145 | Australia |
| Adelaide | South Australia | 5000 | Australia |
| Melbourne | Victoria | 3004 | Australia |
| Melbourne | Victoria | 3186 | Australia |
| Vienna | 1090 | Austria |
| Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Ribeirão Preto | São Paulo | 14049-900 | Brazil |
| Calgary | Alberta | T2N 4Z6 | Canada |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Vancouver | British Columbia | V5Z 1H2 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Vancouver | British Columbia | V6Z 2K5 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M5G 1L7 | Canada |
| La Tronche | 38700 | France |
| Paris | 75651 | France |
| Paris | 75679 | France |
| Pessac | 33604 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Berlin | 13353 | Germany |
| Essen | 45122 | Germany |
| Kiel | 24105 | Germany |
| Tübingen | 72076 | Germany |
| Naples | Campania | 80135 | Italy |
| Milan | Lombardy | 20162 | Italy |
| Pavia | Lombardy | 27100 | Italy |
| Pisa | Tuscany | 56124 | Italy |
| Guadalajara | 44280 | Mexico |
| Guadalajara | 44650 | Mexico |
| Bydgoszcz | 85-030 | Poland |
| Czeladź | 41-250 | Poland |
| Kielce | 25-317 | Poland |
| Lodz | 91-347 | Poland |
| Warsaw | 01-201 | Poland |
| San Juan | 00927 | Puerto Rico |
| Badalona | Barcelona | 08915 | Spain |
| Barcelona | Barcelona | 08003 | Spain |
| Madrid | Madrid | 28034 | Spain |
| Madrid | Madrid | 28222 | Spain |
| Seville | Sevilla | 41014 | Spain |
| Birmingham | B15 2TH | United Kingdom |
| Dundee | DD1 9SY | United Kingdom |
| London | E1 1BB | United Kingdom |
| London | W2 1PG | United Kingdom |
| Manchester | M8 5RB | United Kingdom |
| 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 |
| C553752 | danoprevir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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