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

Phase 2

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Vaniprevir; Drug: Pegylated Interferon (peg-IFN); Drug: Ribavirin

• Registration Number: NCT00880763
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-10
• Study First Submitted QC: 2009-04-10
• Study First Posted: 2009-04-14
• Study Start: 2009-04-20
• Primary Completion: 2010-06-03
• Study Completion: 2012-02-23
• Results First Submitted: 2014-09-26
• Results First Submitted QC: 2014-09-26
• Results First Posted: 2014-09-29
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaniprevir 200 mg + peg-IFN + ribavirin	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.
Vaniprevir 600 mg + peg-IFN + ribavirin	Pegylated Interferon (peg-IFN)	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.
Placebo + peg-IFN + ribavirin	Pegylated Interferon (peg-IFN)	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.
Vaniprevir 200 mg + peg-IFN + ribavirin	Pegylated Interferon (peg-IFN)	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.
Vaniprevir 1200 mg + peg-IFN + ribavirin	Pegylated Interferon (peg-IFN)	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.
Vaniprevir 1200 mg + peg-IFN + ribavirin	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.
Vaniprevir 600 mg + peg-IFN + ribavirin	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.
Placebo + peg-IFN + ribavirin	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.
Vaniprevir 200 mg + peg-IFN + ribavirin	Vaniprevir	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.
Vaniprevir 600 mg + peg-IFN + ribavirin	Vaniprevir	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.
Vaniprevir 1200 mg + peg-IFN + ribavirin	Vaniprevir	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Rapid Viral Response	Week 4	Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was \<1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced at Least One Adverse Event	Up to 6 weeks	An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4	Baseline and Week 4	Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4	Baseline and Week 4	Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
Change From Baseline in HCV RNA in log10 at Week 4	Baseline and Week 4	Change from baseline in HCV RNA at Week 4 was calculated by subtracting Week 4 HCV RNA level from Baseline HCV RNA level. HCV RNA is measured as International Units per milliliter (IU/mL). Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
Number of Participants Who Discontinued Study Drug Due to an Adverse Event	Up to 6 weeks	An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.