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This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys 180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with cirrhosis | Experimental |
| |
| without cirrhosis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir + ritonavir | Drug | 125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 1.5 years | |
| Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir | up to 14 days | |
| Antiviral activity: Change in HCV RNA levels, measured using Roche COBAS TaqMan HCV Test v2.0 for High Pure System | from baseline to Week 36/48 | |
| Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study | approximately 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of viral resistance to danoprevir | approximately 1.5 years | |
| Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4 | approximately 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 |
|---|---|---|---|---|---|---|
| Busan | 614-735 | South Korea | ||||
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| danoprevir + ritonavir | Drug | 125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 24 weeks |
|
| peginterferon alfa-2a [Pegasys] | Drug | 180 mcg sc weekly, 12 weeks |
|
| peginterferon alfa-2a [Pegasys] | Drug | 180 mcg sc weekly, 24 weeks |
|
| ribavirin [Copegus] | Drug | 1000-1200 mg orally daily in divided doses, 12 weeks |
|
| ribavirin [Copegus] | Drug | 1000-1200 mg orally daily in divided doses, 24 weeks |
|
| Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12 |
| approximately 1.5 years |
| Sustained virological response 12 weeks after end of treatment (SVR-12), defined as unquantifiable HCV RNA 8-20 weeks after the last day of study drug administration | approximately 1.5 years |
| Sustained virological response 24 weeks after end of treatment (SVR-24), defined as unquantifiable HCV RNA > 20 weeks after the last day of study drug administration | approximately 1.5 years |
| SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12 | approximately 1.5 years |
| Seoul |
| 110-744 |
| South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 135-710 | South Korea |
| Chiayi County | 61363 | Taiwan |
| Kaohsiung City | 807 | Taiwan |
| Taichung | 40447 | Taiwan |
| Taipei | 100 | Taiwan |
| Taoyuan | 333 | Taiwan |
| Yunlin County | 640 | Taiwan |
| Bangkok | 10330 | Thailand |
| Bangkok | 10700 | Thailand |
| Chiang Mai | 50200 | Thailand |
| 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 |
| D019438 | Ritonavir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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