A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Drug: Comparator: Placebo; Drug: Ribavirin; Drug: Vaniprevir; Drug: Pegylated Interferon (peg-IFN)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00880763

2009_576

7009-016

Details and patient eligibility

About

The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in the placebo group, when each is administered concomitantly with pegylated interferon (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated compared with placebo, when each is administered concomitantly with peg-IFN α-2a and ribavirin for 28 days.

Enrollment: 90 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has chronic genotype 1 Hepatitis C infection

Exclusion criteria

• Has not tolerated previous course of peg-IFN and ribavirin
• Has 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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90 participants in 4 patient groups, including a placebo group

Vaniprevir 200 mg + peg-IFN + ribavirin

Experimental group

Description:

Participants will receive vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.

Treatment:

Drug: Pegylated Interferon (peg-IFN)

Drug: Vaniprevir

Drug: Ribavirin

Vaniprevir 600 mg + peg-IFN + ribavirin

Experimental group

Description:

Participants will receive vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.

Treatment:

Drug: Pegylated Interferon (peg-IFN)

Drug: Vaniprevir

Drug: Ribavirin

Vaniprevir 1200 mg + peg-IFN + ribavirin

Experimental group

Description:

Participants will receive vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.

Treatment:

Drug: Pegylated Interferon (peg-IFN)

Drug: Vaniprevir

Drug: Ribavirin

Placebo + peg-IFN + ribavirin

Placebo Comparator group

Description:

Participants will receive placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.

Treatment:

Drug: Pegylated Interferon (peg-IFN)

Drug: Ribavirin

Drug: Comparator: Placebo