A Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Japanese Patients With Chronic Hepatitis C Infection Who Were Non-responders to Previous Treatment
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 42
- Primary Endpoint
- Percentage of Participants Achieving Sustained Virologic Response (SVR)24
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir (300 mg twice daily) given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) in Japanese participants with chronic hepatitis C (CHC) genotype (GT) 1 who have not responded to previous treatment. The primary efficacy objective is to estimate efficacy of vaniprevir, peg-IFN and RBV for 24 weeks as assessed by the percentage of participants achieving undetectable Hepatitis C Virus ribonucleic acid (HCV RNA) 24 weeks after completion of all study therapy (Sustained Viral Response 24 [SVR24]).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Vaniprevir 24 Week Arm
Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
Intervention: Vaniprevir (Drug)
Vaniprevir 24 Week Arm
Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
Intervention: peg-IFN (Biological)
Vaniprevir 24 Week Arm
Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
Intervention: ribavirin (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Achieving Sustained Virologic Response (SVR)24
Time Frame: 24 weeks after 24 weeks of study therapy (up to 48 weeks)
SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. The percentage of participants achieving SVR24 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.
Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study
Time Frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. For this study, safety parameters or AEs of special interest that were identified a priori included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse experiences (vomiting, nausea, and diarrhea). The percentage of participants with ≥1 specific AEs were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.
Percentage of Participants Who Discontinued Study Drug Due to an AE
Time Frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE.
Secondary Outcomes
- Percentage of Participants Achieving SVR12(12 weeks after 24 weeks of study therapy (up to 36 weeks))
- Percentage of Participants Achieving Rapid Virologic Response (RVR)(At Week 4)
- Percentage of Participants Achieving Complete Early Virologic Response (cEVR)(At Week 12)
- Percentage of Participants Achieving Undetectable HCV Ribonucleic Acid (RNA) at the End of Treatment (EOT)(At Week 24)
- Mean Change From Baseline in HCV RNA (Log 10)(Baseline, Week 2, Week 4, Week 8, Week 12, Week 24)