Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-009608-38 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Placebo | Placebo Comparator | Placebo in combination with standard doses of Pegasys and Copegus. |
|
| Part 1: RO5190591 300mg po | Experimental | RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus. |
|
| Part 1: RO5190591 600mg po | Experimental | RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus. |
|
| Part 1: RO5190591 900mg po | Experimental | RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus. |
|
| Part 2: Placebo | Placebo Comparator | If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive placebo in combination with standard doses of Pegasys and Copegus. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copegus | Drug | 1000 or 1200mg po daily for 24 or 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response | 24 weeks after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Virological response over time | At 2- to 6-weekly intervals throughout study; at end of treatment; 12 weeks post-treatment | |
| Adverse events; laboratory parameters | Throughout study, laboratory parameters every 2 to 6 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|
| 23811112 | Derived | Marcellin P, Cooper C, Balart L, Larrey D, Box T, Yoshida E, Lawitz E, Buggisch P, Ferenci P, Weltman M, Labriola-Tompkins E, Le Pogam S, Najera I, Thomas D, Hooper G, Shulman NS, Zhang Y, Navarro MT, Lim CY, Brunda M, Terrault NA, Yetzer ES. Randomized controlled trial of danoprevir plus peginterferon alfa-2a and ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection. Gastroenterology. 2013 Oct;145(4):790-800.e3. doi: 10.1053/j.gastro.2013.06.051. Epub 2013 Jun 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Part 2: RO5190591 300mg po | Experimental | If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus. |
|
| Pegasys | Drug | 180micrograms sc weekly for 24 or 48 weeks |
|
| Placebo | Drug | po for 12 weeks |
|
| Placebo | Drug | po for 24 weeks |
|
| RO5190591 (Danoprevir) | Drug | 300mg po q8h for 12 weeks |
|
| RO5190591 (Danoprevir) | Drug | 600mg po q12h for 12 weeks |
|
| RO5190591 (Danoprevir) | Drug | 900mg po q12h for 12 weeks |
|
| RO5190591 (Danoprevir) | Drug | 300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks |
|
| Long Beach |
| California |
| 90822 |
| United States |
| Los Angeles | California | 90045 | United States |
| Sacramento | California | 95817 | United States |
| San Diego | California | 92123 | United States |
| San Diego | California | 92154 | United States |
| Aurora | Colorado | 80045 | United States |
| Gainesville | Florida | 32610-0214 | United States |
| Jacksonville | Florida | 32256 | United States |
| Orlando | Florida | 32809 | United States |
| Lombard | Illinois | 60148 | United States |
| New Orleans | Louisiana | 70112 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Detroit | Michigan | 48202-2689 | United States |
| Manhasset | New York | 11030 | United States |
| New York | New York | 10029-6574 | United States |
| Asheville | North Carolina | 28801 | United States |
| Chapel Hill | North Carolina | 27599-7584 | United States |
| Medford | Oregon | 97504 | United States |
| Lancaster | Pennsylvania | 17604-3200 | United States |
| San Antonio | Texas | 78215 | United States |
| Salt Lake City | Utah | 84132 | United States |
| Vancouver | Washington | 98664 | United States |
| Milwaukee | Wisconsin | 53210 | United States |
| Kingswood | New South Wales | Australia |
| Adelaide | South Australia | 5000 | Australia |
| Heidelberg | Victoria | 3084 | Australia |
| Vienna | 1090 | Austria |
| Calgary | Alberta | T2N 4Z6 | Canada |
| Edmonton | Alberta | T5H 4B9 | Canada |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Vancouver | British Columbia | V5Z 1H2 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Winnipeg | Manitoba | R3A 1R9 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M5G 1L7 | Canada |
| Clichy | 92118 | France |
| Marseille | 13285 | France |
| Montpellier | 34295 | France |
| Paris | 75651 | France |
| Frankfurt am Main | 60590 | Germany |
| Hamburg | 20099 | Germany |
| Naples | Campania | 80131 | Italy |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| C553752 | danoprevir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided