Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008258-21 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients in these 3 groups who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks, and group 5 will receive SOC for 48 weeks. Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The anticipated time on study treatment is 6-12 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | RO5024048 500 mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. |
|
| Group 2 | Experimental | RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. |
|
| Group 3 | Experimental | RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. |
|
| Group 4 | Experimental | Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks |
|
| Group 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copegus | Drug | 1000/1200mg po daily for 24 or 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response: Percentage of patients with undetectable Hepatitis C RNA level | 24 weeks after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic response: Percentage of patients with undetectable Hepatitis C RNA level | 60 Weeks | |
| Virologic response: Percentage of patients with undetectable Hepatitis C RNA level | 12 weeks post-treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Group 5 will receive SOC for 48 weeks |
|
| Group 6 | Experimental | Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. |
|
| Copegus | Drug | 1000/1200mg po daily for 48 weeks |
|
| Pegasys | Drug | 180 micrograms sc weekly for 24 or 48 weeks |
|
| Pegasys | Drug | 180 micrograms sc weekly for 48 weeks |
|
| RO5024048 | Drug | 1000mg bid for 24 weeks |
|
| RO5024048 | Drug | 500mg bid for 12 weeks |
|
| RO5024048 | Drug | 1000mg bid for 8 weeks |
|
| RO5024048 | Drug | 1000mg bid for 12 weeks |
|
| Relapse rate: Percentage of patients who achieved a virologic response at the end of treatment but had detectable Hepatitis C RNA level at the last assessment post treatment | 72 weeks |
| Safety: Incidence of adverse events | 72 weeks |
| La Jolla |
| California |
| 92037-1030 |
| United States |
| Sacramento | California | 95817 | United States |
| San Diego | California | 92103-8465 | United States |
| San Francisco | California | 94115 | United States |
| Washington D.C. | District of Columbia | 20037 | United States |
| Bradenton | Florida | 34209 | United States |
| Gainesville | Florida | 32610-0214 | United States |
| Marietta | Georgia | 30060 | United States |
| Chicago | Illinois | 60637 | United States |
| Lutherville | Maryland | 21093 | United States |
| Kansas City | Missouri | 64131 | United States |
| Newark | New Jersey | 07102 | United States |
| New York | New York | 10021 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Providence | Rhode Island | 02905 | United States |
| Columbia | South Carolina | 29204 | United States |
| Nashville | Tennessee | 37211 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78234 | United States |
| Richmond | Virginia | 23249 | United States |
| Sydney | New South Wales | 2050 | Australia |
| Greenslopes | Queensland | 4120 | Australia |
| Herston | Queensland | 4006 | Australia |
| Woolloongabba | Queensland | 4102 | Australia |
| Fitzroy | Victoria | 3065 | Australia |
| Melbourne | Victoria | 3004 | Australia |
| Nedlands | Western Australia | 6009 | Australia |
| Perth | Western Australia | 6001 | Australia |
| Vienna | 1090 | Austria |
| Calgary | Alberta | T2N 4Z6 | Canada |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Vancouver | British Columbia | V6Z 2K5 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Toronto | Ontario | M5G 1L7 | Canada |
| Montreal | Quebec | H2X 3J4 | Canada |
| Créteil | 94010 | France |
| La Tronche | 38700 | France |
| Lille | 59037 | France |
| Nice | 06202 | France |
| Paris | 75651 | France |
| Paris | 75679 | France |
| Pessac | 33604 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Berlin | 13353 | Germany |
| Frankfurt am Main | 60590 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Hanover | 30625 | Germany |
| München | 81377 | Germany |
| Ulm | 89081 | Germany |
| Bologna | Emilia-Romagna | 40138 | Italy |
| Milan | Lombardy | 20121 | Italy |
| Turin | Piedmont | 10126 | Italy |
| Pisa | Tuscany | 56124 | Italy |
| Santurce | 00909 | Puerto Rico |
| Badalona | Barcelona | 08915 | Spain |
| Barcelona | Barcelona | 08003 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Granada | Granada | 18003 | Spain |
| A Coruña | La Coruña | 15006 | Spain |
| Madrid | Madrid | 28222 | Spain |
| Seville | Sevilla | 41014 | Spain |
| Valencia | Valencia | 46014 | Spain |
| London | SE5 9RS | United Kingdom |
| London | W1 1TF | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided