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(MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

Merck Sharp & Dohme (MSD)

Status and phase: Withdrawn; Phase 2

Conditions: Chronic Genotype 1 Hepatitis C Virus Infection

Treatments: Drug: Comparator: vaniprevir (MK7009); Drug: Comparator: Ribavirin; Drug: Comparator: Placebo to vaniprevir; Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Drug: vaniprevir (MK7009)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00895882

2009_586

7009-019

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 6 patient groups, including a placebo group

1

Experimental group

Description:

vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks

Treatment:

Drug: Comparator: Placebo to vaniprevir

Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a

Drug: vaniprevir (MK7009)

Drug: Comparator: Ribavirin

2

Experimental group

Description:

vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 24 weeks

Treatment:

Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a

Drug: vaniprevir (MK7009)

Drug: Comparator: Ribavirin

3

Experimental group

Description:

vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks

Treatment:

Drug: Comparator: Placebo to vaniprevir

Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a

Drug: Comparator: Ribavirin

Drug: Comparator: vaniprevir (MK7009)

4

Experimental group

Description:

vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 24 weeks

Treatment:

Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a

Drug: Comparator: Ribavirin

Drug: Comparator: vaniprevir (MK7009)

5

Experimental group

Description:

vaniprevir 600 mg q.d. + peg-IFN + RBV for 24 weeks

Treatment:

Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a

Drug: Comparator: Ribavirin

Drug: Comparator: vaniprevir (MK7009)

6

Placebo Comparator group

Description:

Placebo to vaniprevir + peg-IFN + RBV for 24 weeks, followed by peg-IFN + RBV for 24 weeks

Treatment:

Drug: Comparator: Placebo to vaniprevir

Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a

Drug: Comparator: Ribavirin