Study to Evaluate Different Regimens of Vaniprevir (MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 Hepatitis C Virus Infection

Conditions
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Chronic Genotype 1 Hepatitis C Virus Infection

Intervention / Treatment
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* Drug: vaniprevir (MK7009)
* Drug: Comparator: vaniprevir (MK7009)
* Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a
* Drug: Comparator: Ribavirin
* Drug: Comparator: Placebo to vaniprevir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has chronic genotype 1 HCV infection Patient has had a liver biopsy without evidence of cirrhosis Patient has had an eye exam prior to the start of study Female patients capable of having children and male patients with female partners capable of having children agree to use two forms of birth control throughout the study Exclusion Criteria: Patient has had previous treatment with: 3 or more doses IFN, peg-IFN, and/or RBV; and stopped treatment due to intolerance of one of the drugs; other antiviral or investigational therapies or vaccines for HCV Female patient is pregnant or breastfeeding Patient has chronic hepatitis not caused by HCV Patient has evidence of cirrhosis of the liver Patient has HIV Patient has active hepatitis B infection Patient has non-genotype 1 HCV infection Patient consumes excessive amounts of alcohol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks | Drug: vaniprevir (MK7009)<br>* vaniprevir 300 mg soft gel capsules twice daily.<br>Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a<br>* Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly<br>Drug: Comparator: Ribavirin<br>* Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.<br>Drug: Comparator: Placebo to vaniprevir<br>* Placebo to vaniprevir soft gel capsules twice daily.<br>|
| Experimental: 2<br>vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 24 weeks | Drug: vaniprevir (MK7009)<br>* vaniprevir 300 mg soft gel capsules twice daily.<br>Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a<br>* Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly<br>Drug: Comparator: Ribavirin<br>* Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.<br>|
| Experimental: 3<br>vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks | Drug: Comparator: vaniprevir (MK7009)<br>* vaniprevir 600 mg soft gel capsules twice daily.<br>Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a<br>* Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly<br>Drug: Comparator: Ribavirin<br>* Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.<br>Drug: Comparator: Placebo to vaniprevir<br>* Placebo to vaniprevir soft gel capsules twice daily.<br>|
| Experimental: 4<br>vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 24 weeks | Drug: Comparator: vaniprevir (MK7009)<br>* vaniprevir 600 mg soft gel capsules twice daily.<br>Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a<br>* Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly<br>Drug: Comparator: Ribavirin<br>* Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.<br>|
| Experimental: 5<br>vaniprevir 600 mg q.d. + peg-IFN + RBV for 24 weeks | Drug: Comparator: vaniprevir (MK7009)<br>* vaniprevir 600 mg soft gel capsules twice daily.<br>Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a<br>* Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly<br>Drug: Comparator: Ribavirin<br>* Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.<br>|
| Placebo Comparator: 6<br>Placebo to vaniprevir + peg-IFN + RBV for 24 weeks, followed by peg-IFN + RBV for 24 weeks | Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a<br>* Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly<br>Drug: Comparator: Ribavirin<br>* Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.<br>Drug: Comparator: Placebo to vaniprevir<br>* Placebo to vaniprevir soft gel capsules twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Proportion of patients achieving SVR24 in Treatment Regimen 5 |  | 1) 24 weeks after end of study therapy |