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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_586 |
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This study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks |
|
| 2 | Experimental | vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 24 weeks |
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| 3 | Experimental | vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks |
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| 4 | Experimental | vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 24 weeks |
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| 5 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaniprevir (MK7009) | Drug | vaniprevir 300 mg soft gel capsules twice daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4 | 24 weeks after end of study therapy | |
| Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data | 72 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 1) Proportion of patients achieving SVR24 in Treatment Regimen 5 | 1) 24 weeks after end of study therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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vaniprevir 600 mg q.d. + peg-IFN + RBV for 24 weeks
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| 6 | Placebo Comparator | Placebo to vaniprevir + peg-IFN + RBV for 24 weeks, followed by peg-IFN + RBV for 24 weeks |
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| Comparator: vaniprevir (MK7009) |
| Drug |
vaniprevir 600 mg soft gel capsules twice daily. |
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| Comparator: Pegylated Interferon (peg-IFN) alfa-2a | Drug | Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly |
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| Comparator: Ribavirin | Drug | Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily. |
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| Comparator: Placebo to vaniprevir | Drug | Placebo to vaniprevir soft gel capsules twice daily. |
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| ID | Term |
|---|---|
| C540393 | vaniprevir |
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