Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01370642
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 294
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vaniprevir 12 Week Arm vaniprevir 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. Vaniprevir 12 Week Arm Peg-IFN 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. Vaniprevir 24 Week Arm Peg-IFN Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV. Control Arm Peg-IFN Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV. Vaniprevir 12 Week Arm Placebo to vaniprevir 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. Control Arm Placebo to vaniprevir Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV. Vaniprevir 12 Week Arm ribavirin 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. Vaniprevir 24 Week Arm vaniprevir Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV. Vaniprevir 24 Week Arm ribavirin Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV. Control Arm ribavirin Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24) 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 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 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 Outcome Measures
Name Time Method Percentage of Participants Achieving SVR12 12 weeks after 24 or 48 weeks of study therapy (up to 60 weeks) SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy.
Percentage of Participants Achieving Rapid Virologic Response (RVR) At Week 4 RVR was defined as having an undetectable HCV RNA level at Week 4.
Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT) At Week 24 or 48 Participants were assessed for undetectable HCV RNA levels at the end of all study therapy.
Percentage of Participants Achieving Complete Early Virologic Response (cEVR) At Week 12 cEVR was defined as having an undetectable HCV RNA level 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 HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered "undetectable".