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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022067-35 |
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This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up.
As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm B Extension | Experimental | All patients in treatment arm B were offered to receive Pegasys/Cogepus therapy for an additional 24 weeks. |
|
| RO5024048 & ritonavir-boosted danoprevir without Ribavirin (B) | Experimental |
| |
| RO5024048 and ritonavir-boosted danoprevir with Ribavirin (A) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copegus placebo | Drug | 1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response, defined as undetectable HVC RNA measured by Roche COBAS TaqMan HCV test | 24 weeks after end of treatment | |
| Safety: Incidence of adverse events | 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Virological response (HCV RNA measured by Roche COBAS Taqman HCV test) | up to 48 weeks | |
| Impact of Copegus (ribavirin) on efficacy of the direct-acting antiviral combination regimen: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test) | 1.5 years |
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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 | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24637689 | Derived | Tong X, Li L, Haines K, Najera I. Identification of the NS5B S282T resistant variant and two novel amino acid substitutions that affect replication capacity in hepatitis C virus-infected patients treated with mericitabine and danoprevir. Antimicrob Agents Chemother. 2014 Jun;58(6):3105-14. doi: 10.1128/AAC.02672-13. Epub 2014 Mar 17. |
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| RO5024048 | Drug | 1000 mg bid orally, up to 24 weeks |
|
| danoprevir | Drug | 100 mg bid orally, up to 24 weeks |
|
| peginterferon alfa-2a [Pegasys] | Drug | 180 mcg sc weekly, 24 weeks |
|
| ribavirin [Copegus] | Drug | 1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks |
|
| ritonavir | Drug | 100 mg bid orally, up to 24 weeks |
|
| Comparison of 12 and 24 weeks of treatment duration: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test) | 1.5 years |
| Pharmacokinetics: Plasma concentrations of danoprevir, ritonavir, RO4995855 (parent drug of RO5024048) and ribavirin | up to 24 weeks |
| Viral resistance: HCV RNA sequencing and phenotypic analyses | up to 48 weeks |
| Effect of interleukin 28B genotype on efficacy: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test) | 1.5 years |
| Quality of life: SF-36 questionnaire, Fatigue Severity Scale | up to 36 weeks |
| Sacramento |
| California |
| 95817 |
| United States |
| Orlando | Florida | 32809 | United States |
| Marietta | Georgia | 30060 | United States |
| Honolulu | Hawaii | 96814 | United States |
| Honolulu | Hawaii | 96817 | United States |
| Chicago | Illinois | 60637 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Lutherville | Maryland | 21093 | United States |
| Detroit | Michigan | 48202 | United States |
| Newark | New Jersey | 07102 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| New York | New York | 10021 | United States |
| Providence | Rhode Island | 02905 | United States |
| Nashville | Tennessee | 37211 | United States |
| Houston | Texas | 77030 | United States |
| Newport News | Virginia | 23602 | United States |
| Vancouver | Washington | 98664 | United States |
| Clichy | 92118 | France |
| Créteil | 94010 | France |
| Lille | 59037 | France |
| Marseille | 13285 | France |
| Montpellier | 34295 | France |
| Paris | 75651 | France |
| Berlin | 10969 | Germany |
| Berlin | 13353 | Germany |
| Frankfurt am Main | 60590 | Germany |
| Hamburg | 20099 | Germany |
| Hanover | 30625 | Germany |
| Kiel | 24146 | Germany |
| Leipzig | 04103 | Germany |
| Grafton | 1010 | New Zealand |
| 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 |
|---|---|
| C553752 | danoprevir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| 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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