Safety and Efficacy of Vaniprevir (MK7009) Administered W... | NCT00704184 | Trialant
NCT00704184
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Oct 9, 2018Actual
Enrollment
95Actual
Phase
Phase 2
Conditions
Hepatitis C
Interventions
Comparator: Vaniprevir
Comparator: Pegylated-Interferon (Peg-IFN)
Comparator: Ribavirin
Comparator: placebo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00704184
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
7009-007
Secondary IDs
ID
Type
Description
Link
MK7009-007
2007_658
Brief Title
Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)
Official Title
A Phase II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Sep 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 25, 2008Actual
Primary Completion Date
Dec 12, 2008Actual
Completion Date
Apr 14, 2010Actual
First Submitted Date
Jun 23, 2008
First Submission Date that Met QC Criteria
Jun 23, 2008
First Posted Date
Jun 24, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 26, 2014
Results First Submitted that Met QC Criteria
Sep 26, 2014
Results First Posted Date
Oct 1, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 10, 2018
Last Update Posted Date
Oct 9, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus [HCV] viral ribonucleic acid [RNA] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.
Detailed Description
Not provided
Conditions Module
Conditions
Hepatitis C
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
95Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo + Peg-IFN/Ribavirin
Placebo Comparator
Participants took double-blind Placebo + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Drug: Comparator: Pegylated-Interferon (Peg-IFN)
Drug: Comparator: Ribavirin
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Experimental
Participants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Drug: Comparator: Vaniprevir
Drug: Comparator: Pegylated-Interferon (Peg-IFN)
Drug: Comparator: Ribavirin
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Experimental
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Drug: Comparator: Vaniprevir
Drug: Comparator: Pegylated-Interferon (Peg-IFN)
Drug: Comparator: Ribavirin
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Experimental
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Drug: Comparator: Vaniprevir
Drug: Comparator: Pegylated-Interferon (Peg-IFN)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Comparator: Vaniprevir
Drug
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving RVR
Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.
Week 4
Number of Participants Experiencing an Adverse Event (AE)
The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.
Up to Day 42
Number of Participants Discontinuing From Study Therapy Due to AEs
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 study therapy, whether or not considered related to the use of the product.
Day 1 to Day 28
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With ≥2-log10 Decrease in HCV RNA
The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
Baseline and Week 4
Number of Participants With ≥3-log10 Decrease in HCV RNA
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient has chronic Genotype 1 Hepatitis C infection
Exclusion Criteria:
Subject has been previously treated for HCV
Has Human Immunodeficiency Virus (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
Manns MP, Gane E, Rodriguez-Torres M, Stoehr A, Yeh CT, Marcellin P, Wiedmann RT, Hwang PM, Caro L, Barnard RJ, Lee AW; MK-7009 Protocol 007 Study Group. Vaniprevir with pegylated interferon alpha-2a and ribavirin in treatment-naive patients with chronic hepatitis C: a randomized phase II study. Hepatology. 2012 Sep;56(3):884-93. doi: 10.1002/hep.25743. Epub 2012 Jul 17.
During the double-blind phase (Day 1 to Day 28), participants took Vaniprevir or Placebo in combination with Pegylated Interferon (Peg-IFN)/Ribavirin. During the open-label phase (Day 29 to Week 48), participants took Peg-IFN/Ribavirin only.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
FG001
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Periods
Title
Milestones
Reasons Not Completed
Double-Blind Treatment
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Austria
Canada
Colombia
Czechia
Denmark
France
Germany
Israel
New Zealand
Puerto Rico
Russia
Spain
Switzerland
Taiwan
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Comparator: Ribavirin
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Experimental
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Drug: Comparator: Vaniprevir
Drug: Comparator: Pegylated-Interferon (Peg-IFN)
Drug: Comparator: Ribavirin
Drug: Comparator: placebo
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
MK-7009
Comparator: Pegylated-Interferon (Peg-IFN)
Drug
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Placebo + Peg-IFN/Ribavirin
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Comparator: Ribavirin
Drug
Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks
Placebo + Peg-IFN/Ribavirin
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Comparator: placebo
Drug
Matching placebo to vaniprevir; duration of treatment: 28 days
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
Baseline and Week 4
Mean Log Change From Baseline in HCV RNA
The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.
Baseline and Week 4
Derived
Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7.
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
FG002
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
FG003
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
FG004
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
FG00020 subjects
FG00118 subjects
FG00220 subjects
FG00318 subjects
FG00419 subjects
Treated
FG00019 subjectsOne participant was randomized to placebo but withdrew prior to receiving study medication.
FG00118 subjects
FG00220 subjects
FG00318 subjects
FG00419 subjects
COMPLETED
FG00019 subjects
FG00118 subjects
FG00220 subjects
FG00318 subjects
FG00419 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Open-Label Treatment
Type
Comment
Milestone Data
STARTED
FG00019 subjects
FG00118 subjects
FG00220 subjects
FG00318 subjects
FG00419 subjects
COMPLETED
FG00018 subjects
FG00116 subjects
FG00216 subjects
FG00313 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG0024 subjects
FG0035 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG003
The baseline population consists of all participants treated with study medication. One participant was randomized to the placebo group but withdrew from the study prior to taking any study medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
BG001
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
BG002
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
BG003
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
BG004
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00019
BG00118
BG00220
BG00318
BG00419
BG00594
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00047.8± 10.1
BG00146.7± 10.2
BG00242.0± 10.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0014
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving RVR
Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.
The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.
Posted
Number
Percentage of Participants
Week 4
ID
Title
Description
OG000
Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG001
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG002
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG003
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG004
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
Units
Counts
Participants
OG00018
OG00116
OG00219
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.6
OG00175.0
OG00278.9
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Miettinen and Nurminen method
<0.001
Adjusted difference in %
69.3
2-Sided
95
40.3
86.7
Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).
Superiority or Other
OG000
OG002
Miettinen and Nurminen method
Primary
Number of Participants Experiencing an Adverse Event (AE)
The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
Posted
Number
Participants
Up to Day 42
ID
Title
Description
OG000
Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG001
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG002
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG003
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Primary
Number of Participants Discontinuing From Study Therapy Due to AEs
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 study therapy, whether or not considered related to the use of the product.
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy
Posted
Number
Participants
Day 1 to Day 28
ID
Title
Description
OG000
Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG001
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG002
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG003
Secondary
Number of Participants With ≥2-log10 Decrease in HCV RNA
The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.
Posted
Number
Number of Participants
Baseline and Week 4
ID
Title
Description
OG000
Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG001
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG002
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
Secondary
Number of Participants With ≥3-log10 Decrease in HCV RNA
The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.
Posted
Number
Number of Participants
Baseline and Week 4
ID
Title
Description
OG000
Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG001
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG002
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
Secondary
Mean Log Change From Baseline in HCV RNA
The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.
The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.
Posted
Mean
Standard Deviation
Log10 IU/mL
Baseline and Week 4
ID
Title
Description
OG000
Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG001
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG002
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
Time Frame
AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
Description
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1
19
19
19
EG001
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
3
18
16
18
EG002
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1
20
20
20
EG003
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
2
18
17
18
EG004
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
2
19
18
19
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cholecystitis acute
Hepatobiliary disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG0031 events1 affected18 at risk
EG0040 events0 affected19 at risk
Appendicitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Empyema
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Septic shock
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 13.0
Systematic Assessment
EG0003 events3 affected19 at risk
EG0012 events2 affected18 at risk
EG0022 events2 affected20 at risk
EG0031 events1 affected18 at risk
EG0041 events1 affected19 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA version 13.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0011 events1 affected18 at risk
EG0022 events2 affected20 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA version 13.0
Systematic Assessment
EG0002 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Palpitations
Cardiac disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA version 13.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events1 affected18 at risk
EG0022 events1 affected20 at risk
EG003
Vision blurred
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Vision acuity reduced
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Visual brightness
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Visual impairment
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Xerophthalmia
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0022 events1 affected20 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0023 events1 affected20 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0005 events3 affected19 at risk
EG0011 events1 affected18 at risk
EG0023 events3 affected20 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0004 events4 affected19 at risk
EG0011 events1 affected18 at risk
EG0028 events7 affected20 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0022 events2 affected20 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0004 events4 affected19 at risk
EG0014 events4 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Gastrooesophogeal reflux disease
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected20 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Lip erosion
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0007 events6 affected19 at risk
EG0017 events5 affected18 at risk
EG00214 events8 affected20 at risk
EG003
Oesophogeal pain
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG00216 events9 affected20 at risk
EG003
Asthenia
General disorders
MedDRA version 13.0
Systematic Assessment
EG0005 events4 affected19 at risk
EG0012 events2 affected18 at risk
EG0026 events4 affected20 at risk
EG003
Chest pain
General disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Chills
General disorders
MedDRA version 13.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Discomfort
General disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Fatigue
General disorders
MedDRA version 13.0
Systematic Assessment
EG0007 events7 affected19 at risk
EG0013 events3 affected18 at risk
EG00210 events7 affected20 at risk
EG003
Feeling cold
General disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Influenza like illness
General disorders
MedDRA version 13.0
Systematic Assessment
EG0005 events4 affected19 at risk
EG0014 events4 affected18 at risk
EG0024 events4 affected20 at risk
EG003
Injection site erythema
General disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events2 affected18 at risk
EG0022 events2 affected20 at risk
EG003
Injection site irritation
General disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Injection site reaction
General disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Irritability
General disorders
MedDRA version 13.0
Systematic Assessment
EG0004 events3 affected19 at risk
EG0013 events2 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Mucosal dryness
General disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Mucosal inflammation
General disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0023 events1 affected20 at risk
EG003
Pain
General disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0023 events3 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA version 13.0
Systematic Assessment
EG0003 events2 affected19 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected20 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Bronchitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Ear infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hordeolum
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Laryngitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Oral herpes
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Tinea infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected20 at risk
EG003
Viral infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Blood glucose increased
Investigations
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Body temperature decreased
Investigations
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Body temperature increased
Investigations
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0012 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Glucose urine present
Investigations
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected20 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Platelet count decreased
Investigations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Weight decreased
Investigations
MedDRA version 13.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected20 at risk
EG003
White blood cell count decreased
Investigations
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Appetite disorder
Metabolism and nutrition disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 13.0
Systematic Assessment
EG0003 events2 affected19 at risk
EG0014 events4 affected18 at risk
EG0026 events6 affected20 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0014 events3 affected18 at risk
EG0024 events2 affected20 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0025 events3 affected20 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events2 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0003 events3 affected19 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Myosclerosis
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0024 events1 affected20 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cervicobrachial syndrome
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Coordination abnormal
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Head discomfort
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Headache
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG00010 events7 affected19 at risk
EG0014 events4 affected18 at risk
EG00212 events9 affected20 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Intercostal neuralgia
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Poor quality sleep
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Somnolence
Nervous system disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Agitation
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0012 events2 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0023 events3 affected20 at risk
EG003
Depression
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0003 events3 affected19 at risk
EG0013 events3 affected18 at risk
EG0022 events2 affected20 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Dysthymic disorder
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Initial insomnia
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0014 events4 affected18 at risk
EG0024 events4 affected20 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA version 13.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Urine odour abnormal
Renal and urinary disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0013 events2 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0003 events3 affected19 at risk
EG0014 events3 affected18 at risk
EG0023 events2 affected20 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0005 events5 affected19 at risk
EG0013 events3 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0022 events2 affected20 at risk
EG003
Nasal ulcer
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0022 events1 affected20 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected20 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0003 events3 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0006 events6 affected19 at risk
EG0011 events1 affected18 at risk
EG0023 events3 affected20 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events2 affected18 at risk
EG0024 events3 affected20 at risk
EG003
Eczema nummular
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0002 events2 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0024 events3 affected20 at risk
EG003
Hypotrichosis
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0008 events4 affected19 at risk
EG0014 events4 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0005 events4 affected19 at risk
EG0016 events3 affected18 at risk
EG0022 events2 affected20 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0022 events1 affected20 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events2 affected18 at risk
EG0022 events1 affected20 at risk
EG003
Skin reaction
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hot flush
Vascular disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hyperaemia
Vascular disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Dry eye
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Eye irritation
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Eye pain
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0002 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Eye pruritus
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Eye swelling
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Eyelid function disorder
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Ocular icterus
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Photopsia
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Diplopia
Eye disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected20 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA version 13.0
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected20 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
ID
Term
D006526
Hepatitis C
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D006525
Hepatitis, Viral, Human
D014777
Virus Diseases
D018178
Flaviviridae Infections
D012327
RNA Virus Infections
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C540393
vaniprevir
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
16 subjects
3 subjects
0 subjects
FG0041 subjects
Lack of Efficacy
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0041 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG0040 subjects
50.1
± 8.4
BG00445.1± 12.0
BG00546.2± 10.5
9
BG00311
BG0047
BG00539
Male
BG00011
BG00114
BG00211
BG0037
BG00412
BG00555
16
OG00418
68.8
OG00483.3
<0.001
Adjusted difference in %
73.6
2-Sided
95
46.0
88.6
Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).
Superiority or Other
OG000
OG003
Miettinen and Nurminen method
<0.001
Adjusted difference in %
63.3
2-Sided
95
32.8
82.7
Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).
Superiority or Other
OG000
OG004
Miettinen and Nurminen method
<0.001
Adjusted difference in %
77.8
2-Sided
95
49.2
91.3
Adjusted difference subtracts the percentage of placebo responders (5.3) and stratifies by HCV genotype (1a vs. non-1a).
Superiority or Other
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG004
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
Units
Counts
Participants
OG00019
OG00118
OG00220
OG00318
OG00419
Title
Denominators
Categories
Title
Measurements
OG00018
OG00115
OG00218
OG00316
OG00418
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG004
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
Units
Counts
Participants
OG00019
OG00118
OG00220
OG00318
OG00419
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG003
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG004
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
Units
Counts
Participants
OG00018
OG00116
OG00219
OG00316
OG00418
Title
Denominators
Categories
Title
Measurements
OG00016
OG00116
OG00219
OG00316
OG00417
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Adjusted difference
11.2
2-Sided
95
-9.7
33.8
Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).
Superiority or Other
OG000
OG002
Adjusted difference
10.8
2-Sided
95
-7.6
33.2
Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).
Superiority or Other
OG000
OG003
Adjusted difference
11.2
2-Sided
95
-9.7
33.8
Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).
Superiority or Other
OG000
OG004
Adjusted difference
5.4
2-Sided
95
-16.5
28.4
Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).
Superiority or Other
OG003
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG004
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
Units
Counts
Participants
OG00018
OG00116
OG00219
OG00316
OG00418
Title
Denominators
Categories
Title
Measurements
OG00015
OG00116
OG00219
OG00316
OG00417
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Adjusted difference
16.9
2-Sided
95
-4.0
40.2
Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).
Superiority or Other
OG000
OG002
Adjusted difference
16.2
2-Sided
95
-2.2
39.5
Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).
Superiority or Other
OG000
OG003
Adjusted difference
16.9
2-Sided
95
-4.0
40.2
Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).
Superiority or Other
OG000
OG004
Adjusted difference
10.7
2-Sided
95
-11.4
34.6
Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).
Superiority or Other
OG003
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
OG004
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
Units
Counts
Participants
OG00018
OG00116
OG00219
OG00317
OG00418
Title
Denominators
Categories
Title
Measurements
OG000-3.6± 1.3
OG001-6.1± 1.1
OG002-6.3± 0.7
OG003-6.2± 0.6
OG004-6.3± 1.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in Least Squares (LC) Means
-2.5
2-Sided
95
-3.2
-1.8
The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.
Superiority or Other
OG000
OG002
Difference in LS Means
-2.7
2-Sided
95
-3.4
-2.0
The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.
Superiority or Other
OG000
OG003
Difference in LS Means
-2.7
2-Sided
95
-3.4
-2.0
The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.
Superiority or Other
OG000
OG004
Difference in LS Means
-2.7
2-Sided
95
-3.3
-2.0
The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.