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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022659-41 | EudraCT Number |
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This randomized, double blind, phase II study will evaluate the efficacy and safety of two doses of RO5024048 in combination with ritonavir-boosted danoprevir and Pegasys (peginterferon alpha-2a) and Copegus (ribavirin) in patients who failed a prior protease inhibitor containing regimen with or without pegylated interferon. Patients will be randomized to receive either a 2-week lead-in of RO5024048 (1500 mg or 1000 mg orally twice daily) in combination with Pegasys (180 mcg subcutaneously weekly) and Copegus (1000 mg or 1200 mg orally daily) followed by 24 weeks of therapy with RO5024048 in combination with danoprevir (100 mg orally twice daily) plus ritonavir (100 mg orally twice daily) and Pegasys and Copegus (QUAD therapy), or 24 weeks of therapy with RO5024048 in combination with danoprevir plus ritonavir and Pegasys and Copegus (QUAD therapy). Anticipated time on study treatment is 24 or 26 weeks, with a treatment-free follow-up of 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1000 mg 24 weeks | Active Comparator |
| |
| 1000 mg 26 weeks | Active Comparator |
| |
| 1500 mg 24 weeks | Experimental |
| |
| 1500 mg 26 weeks | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5024048 | Drug | 1500 mg po bid, 24 or 26 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response (defined as unquantifiable serum HCV RNA) 12 weeks after treatment (SVR-12) | approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virologic response 4 weeks after treatment (SVR-4) | approximately 2 years | |
| Sustained virologic response 24 weeks after treatment (SVR-24) | approximately 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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| RO5024048 |
| Drug |
1000 mg po bid, 24 or 26 weeks |
|
| danoprevir | Drug | 100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26 |
|
| peginterferon alfa-2a [Pegasys] | Drug | 180 mcg sc qw, 24 or 26 weeks |
|
| ribavirin [Copegus] | Drug | 1000 mg or 1200 mg po daily, 24 or 26 weeks |
|
| ritonavir | Drug | 100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26 |
|
| Change in serum HCV RNA levels |
| from baseline to Week 12 |
| Virologic response over time | from baseline to 24 weeks after treatment |
| Correlation between trough concentrations of RO4995855 and virologic response | approximately 2 years |
| Incidence of direct-acting antiviral (DAA) resistance, including re-emergence of protease inhibitor resistant virus | approximately 2 years |
| Safety: Incidence of adverse events | approximately 2 years |
| 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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