A Phase III Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Japanese Treatment-Naïve Patients With Chronic Hepatitis C Infection
Overview
- Phase
- Phase 3
- Intervention
- vaniprevir
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 294
- Primary Endpoint
- Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic hepatitis C (CHC) genotype (GT)1. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir arms is superior to the percentage of participants achieving SVR24 in the control arm.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Vaniprevir 12 Week Arm
Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
Intervention: vaniprevir
Vaniprevir 12 Week Arm
Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
Intervention: Placebo to vaniprevir
Vaniprevir 12 Week Arm
Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
Intervention: Peg-IFN
Vaniprevir 12 Week Arm
Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
Intervention: ribavirin
Vaniprevir 24 Week Arm
Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
Intervention: vaniprevir
Vaniprevir 24 Week Arm
Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
Intervention: Peg-IFN
Vaniprevir 24 Week Arm
Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
Intervention: ribavirin
Control Arm
Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Intervention: Placebo to vaniprevir
Control Arm
Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Intervention: Peg-IFN
Control Arm
Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Intervention: ribavirin
Outcomes
Primary Outcomes
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)
Time Frame: 24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks)
SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy.
Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study
Time Frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)
An adverse experience 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 adverse experience. For this study, safety parameters or AEs of special interest that were identified a priori constituted "Tier 1" safety endpoints that were subject to inferential testing for statistical significance. Tier 1 AEs on this study included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse (GI) experiences (vomiting, nausea, and diarrhea).
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 72 weeks)
An adverse experience 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 adverse experience.
Secondary Outcomes
- Percentage of Participants Achieving SVR12(12 weeks after 24 or 48 weeks of study therapy (up to 60 weeks))
- Percentage of Participants Achieving Rapid Virologic Response (RVR)(At Week 4)
- Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)(At Week 24 or 48)
- Percentage of Participants Achieving Complete Early Virologic Response (cEVR)(At Week 12)
- Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10)(Baseline, Week 2, Week 4, Week 8, Week 12, Week 24)