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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019584-10 |
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This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks |
|
| Group B | Experimental | Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks |
|
| Group C | Experimental | Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks |
|
| Group D | Experimental | Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks |
|
| Group E | Active Comparator | Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 48 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copegus | Drug | Copegus 1000 mg or 1200 mg po daily for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response (HCV RNA measured by Roche COBAS TaqMan HCV test) | 24 weeks after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | from baseline up to 72 weeks | |
| Evaluation of relapse rate | up to 24 weeks after end of treatment | |
| Characterization of resistance profile (HCV RNA sequencing and/or phenotypic analyses) |
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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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|
| Danoprevir | Drug | Danoprevir 50 mg BID |
|
| Danoprevir | Drug | Danoprevir 100 mg BID |
|
| Danoprevir | Drug | Danoprevir 200 mg BID |
|
| Pegasys | Drug | Pegasys 180 microgram sc qw |
|
| Ritonavir | Drug | Ritonavir 100 mg |
|
| from baseline up to 72 weeks |
| Virological response at scheduled visits over time (HCV RNA measured by Roche COBAS TaqMan HCV test) | From baseline up to 72 weeks |
| Evaluation of virological breakthrough (viral load rebound) rate | up to 72 weeks |
| Evaluation of pharmacokinetics (serum concentrations assessed by validated methods) | up to 72 weeks |
| Sacramento |
| California |
| 95817 |
| United States |
| San Diego | California | 92154 | United States |
| San Francisco | California | 94143 | United States |
| Aurora | Colorado | 80045 | United States |
| Orlando | Florida | 32804 | United States |
| Orlando | Florida | 32809 | United States |
| South Miami | Florida | 33143 | United States |
| Decatur | Georgia | 30033 | United States |
| Honolulu | Hawaii | 96817 | United States |
| Chicago | Illinois | 60637 | United States |
| Lutherville | Maryland | 21093 | United States |
| Detroit | Michigan | 48202-2689 | 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 |
| Fayetteville | North Carolina | 28304 | 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 |
| Newport News | Virginia | 23602 | United States |
| Vienna | 1090 | Austria |
| Salvador | Estado de Bahia | 40210-341 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Ribeirão Preto | São Paulo | 14049-900 | Brazil |
| Edmonton | Alberta | T6G 2S2 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Vancouver | British Columbia | V6Z 2K5 | Canada |
| Victoria | British Columbia | V8V 3P9 | Canada |
| Winnipeg | Manitoba | R3A 1R9 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M5G 1L7 | Canada |
| Clichy | 92118 | France |
| Créteil | 94010 | France |
| Marseille | 13285 | France |
| Paris | 75679 | France |
| Rennes | 35033 | France |
| Toulouse | 31059 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Berlin | 10969 | Germany |
| Frankfurt am Main | 60590 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Hamburg | 20099 | Germany |
| Leipzig | 04103 | Germany |
| Würzburg | 97080 | Germany |
| Bari | Apulia | 70124 | Italy |
| Naples | Campania | 80131 | Italy |
| Bologna | Emilia-Romagna | 40138 | Italy |
| Milan | Lombardy | 20121 | Italy |
| Pavia | Lombardy | 27100 | Italy |
| Novara | Piedmont | 28100 | Italy |
| Guadalajara | 44650 | Mexico |
| Monterrey | 64710 | Mexico |
| Santurce | 00909 | Puerto Rico |
| Badalona | Barcelona | 08915 | Spain |
| Barcelona | Barcelona | 08003 | Spain |
| Madrid | Madrid | 28034 | Spain |
| Madrid | Madrid | 28222 | Spain |
| Seville | Sevilla | 41014 | Spain |
| London | E1 1BB | United Kingdom |
| London | SE5 9RS | United Kingdom |
| London | SW17 0QT | United Kingdom |
| London | W1 1TF | United Kingdom |
| Nottingham | NG7 2UH | 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 |
| C553752 | danoprevir |
| C100416 | peginterferon alfa-2a |
| 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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