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

NCT ID: NCT00880763

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-20
• Study Completion Date: 2012-02-23

Brief Summary

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vaniprevir 200 mg + peg-IFN + ribavirin

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.

Group Type: EXPERIMENTAL

Vaniprevir

Intervention Type: DRUG

Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days

Pegylated Interferon (peg-IFN)

Intervention Type: DRUG

Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks

Ribavirin

Intervention Type: DRUG

Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks

Vaniprevir 600 mg + peg-IFN + ribavirin

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.

Group Type: EXPERIMENTAL

Vaniprevir

Intervention Type: DRUG

Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days

Pegylated Interferon (peg-IFN)

Intervention Type: DRUG

Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks

Ribavirin

Intervention Type: DRUG

Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks

Vaniprevir 1200 mg + peg-IFN + ribavirin

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.

Group Type: EXPERIMENTAL

Vaniprevir

Intervention Type: DRUG

Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days

Pegylated Interferon (peg-IFN)

Intervention Type: DRUG

Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks

Ribavirin

Intervention Type: DRUG

Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks

Placebo + peg-IFN + ribavirin

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.

Group Type: PLACEBO_COMPARATOR

Pegylated Interferon (peg-IFN)

Intervention Type: DRUG

Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks

Ribavirin

Intervention Type: DRUG

Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks

Comparator: Placebo

Intervention Type: DRUG

Placebo to vaniprevir oral capsule twice daily for 28 days

Interventions

Vaniprevir

Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days

Intervention Type: DRUG

Pegylated Interferon (peg-IFN)

Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks

Intervention Type: DRUG

Ribavirin

Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks

Intervention Type: DRUG

Comparator: Placebo

Placebo to vaniprevir oral capsule twice daily for 28 days

Intervention Type: DRUG

Other Intervention Names

MK7009

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Hayashi N, Mobashery N, Izumi N. Vaniprevir plus peginterferon alfa-2a and ribavirin in treatment-experienced Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase II study. J Gastroenterol. 2015 Feb;50(2):238-48. doi: 10.1007/s00535-014-0979-2. Epub 2014 Aug 13.

Reference Type: RESULT

PMID: 25115901 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2009_576

Identifier Type: -

Identifier Source: secondary_id

7009-016

Identifier Type: -

Identifier Source: org_study_id