Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-25

Study Completion Date

2010-04-14

Brief Summary

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A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus \[HCV\] viral ribonucleic acid \[RNA\] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo + Peg-IFN/Ribavirin

Participants took double-blind Placebo + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

Group Type PLACEBO_COMPARATOR

Comparator: Pegylated-Interferon (Peg-IFN)

Intervention Type DRUG

Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks

Comparator: Ribavirin

Intervention Type DRUG

Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks

Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin

Participants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

Group Type EXPERIMENTAL

Comparator: Vaniprevir

Intervention Type DRUG

Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days

Comparator: Pegylated-Interferon (Peg-IFN)

Intervention Type DRUG

Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks

Comparator: Ribavirin

Intervention Type DRUG

Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks

Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin

Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

Group Type EXPERIMENTAL

Comparator: Vaniprevir

Intervention Type DRUG

Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days

Comparator: Pegylated-Interferon (Peg-IFN)

Intervention Type DRUG

Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks

Comparator: Ribavirin

Intervention Type DRUG

Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks

Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin

Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

Group Type EXPERIMENTAL

Comparator: Vaniprevir

Intervention Type DRUG

Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days

Comparator: Pegylated-Interferon (Peg-IFN)

Intervention Type DRUG

Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks

Comparator: Ribavirin

Intervention Type DRUG

Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks

Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin

Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

Group Type EXPERIMENTAL

Comparator: Vaniprevir

Intervention Type DRUG

Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days

Comparator: Pegylated-Interferon (Peg-IFN)

Intervention Type DRUG

Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks

Comparator: Ribavirin

Intervention Type DRUG

Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks

Comparator: placebo

Intervention Type DRUG

Matching placebo to vaniprevir; duration of treatment: 28 days

Interventions

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Comparator: Vaniprevir

Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days

Intervention Type DRUG

Comparator: Pegylated-Interferon (Peg-IFN)

Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks

Intervention Type DRUG

Comparator: Ribavirin

Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks

Intervention Type DRUG

Comparator: placebo

Matching placebo to vaniprevir; duration of treatment: 28 days

Intervention Type DRUG

Other Intervention Names

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MK-7009

Eligibility Criteria

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Inclusion Criteria

* Patient has chronic Genotype 1 Hepatitis C infection

Exclusion Criteria

* Subject has been previously treated for HCV
* Has Human Immunodeficiency Virus (HIV)
* Has Hepatitis B
* Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and Ribavirin

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No