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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Drug: Comparator: Pegylated-Interferon (Peg-IFN); Drug: Comparator: Vaniprevir; Drug: Comparator: Ribavirin; Drug: Comparator: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00704184

MK7009-007

7009-007

2007_658

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 5 patient groups, including a placebo group

Placebo + Peg-IFN/Ribavirin

Placebo Comparator group

Description:

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.

Treatment:

Drug: Comparator: Ribavirin

Drug: Comparator: Pegylated-Interferon (Peg-IFN)

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

Experimental group

Description:

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.

Treatment:

Drug: Comparator: Ribavirin

Drug: Comparator: Pegylated-Interferon (Peg-IFN)

Drug: Comparator: Vaniprevir

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

Experimental group

Description:

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.

Treatment:

Drug: Comparator: Ribavirin

Drug: Comparator: Pegylated-Interferon (Peg-IFN)

Drug: Comparator: Vaniprevir

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

Experimental group

Description:

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.

Treatment:

Drug: Comparator: Ribavirin

Drug: Comparator: Pegylated-Interferon (Peg-IFN)

Drug: Comparator: Vaniprevir

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

Experimental group

Description:

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.

Treatment:

Drug: Comparator: placebo

Drug: Comparator: Ribavirin

Drug: Comparator: Pegylated-Interferon (Peg-IFN)

Drug: Comparator: Vaniprevir