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Trial record 81 of 2128 for:    Hepatitis C

Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)

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ClinicalTrials.gov Identifier: NCT00704405
Recruitment Status : Completed
First Posted : June 24, 2008
Results First Posted : September 29, 2014
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: Vaniprevir
Drug: Pegylated Interferon (Peg-IFN)
Drug: Ribavirin (RBV)
Drug: Placebo (PBO)
Enrollment 285
Recruitment Details Non-cirrhotic (NC) and cirrhotic (C) participants were screened and enrolled separately in this study. The NC population was used for all safety, tolerability, and efficacy outcome measures. Primary analyses of the outcome measures only included the NC population. Adverse events (AEs) were monitored in both the NC and C populations.
Pre-assignment Details  
Arm/Group Title 24-wk Vaniprevir 600 mg + Peg-IFN/RBV 24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV 48-wk Vaniprevir 300 mg + Peg-IFN/RBV 48-wk Vaniprevir 600 mg + Peg-IFN/RBV 48-wk PBO + Peg-IFN/RBV
Hide Arm/Group Description Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks. Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks. Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks. Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks. PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Period Title: Overall Study (NC Population)
Started 42 44 41 42 42
Completed 37 40 38 38 37
Not Completed 5 4 3 4 5
Reason Not Completed
Adverse Event             1             0             0             0             0
Lost to Follow-up             2             1             1             2             2
Withdrawal by Subject             2             3             2             2             2
Other             0             0             0             0             1
Period Title: Overall Study (C Population)
Started 16 14 15 15 14
Completed 15 11 14 14 14
Not Completed 1 3 1 1 0
Reason Not Completed
Withdrawal by Subject             1             1             1             1             0
Lost to Follow-up             0             2             0             0             0
Arm/Group Title 24-wk Vaniprevir 600 mg + Peg-IFN/RBV 24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV 48-wk Vaniprevir 300 mg + Peg-IFN/RBV 48-wk Vaniprevir 600 mg + Peg-IFN/RBV 48-wk PBO + Peg-IFN/RBV Total
Hide Arm/Group Description Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks. Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks. Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks. Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks. PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 58 58 56 57 56 285
Hide Baseline Analysis Population Description
The Baseline Population consists of all randomized C and NC participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 58 participants 56 participants 57 participants 56 participants 285 participants
50.0  (8.4) 51.6  (8.1) 50.6  (7.5) 52.1  (8.7) 49.9  (7.8) 50.8  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 56 participants 57 participants 56 participants 285 participants
Female
25
  43.1%
24
  41.4%
16
  28.6%
19
  33.3%
21
  37.5%
105
  36.8%
Male
33
  56.9%
34
  58.6%
40
  71.4%
38
  66.7%
35
  62.5%
180
  63.2%
1.Primary Outcome
Title Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.
Hide Description The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure.
Time Frame Up to 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.
Arm/Group Title 24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV 24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV 48-wk Vaniprevir 600 mg + Peg-IFN/RBV 48-wk PBO + Peg-IFN/RBV
Hide Arm/Group Description:
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Overall Number of Participants Analyzed 38 38 41 42
Measure Type: Number
Unit of Measure: Percentage of participants
71.1 84.2 78.0 19.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV, 48-wk PBO + Peg-IFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in percentage
Estimated Value 53.6
Confidence Interval (2-Sided) 95%
34.5 to 69.1
Estimation Comments Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV, 48-wk PBO + Peg-IFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in percentage
Estimated Value 64.4
Confidence Interval (2-Sided) 95%
45.2 to 78.3
Estimation Comments Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 48-wk Vaniprevir 600 mg + Peg-IFN/RBV, 48-wk PBO + Peg-IFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in percentage
Estimated Value 59.0
Confidence Interval (2-Sided) 95%
40.2 to 73.4
Estimation Comments Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.
2.Primary Outcome
Title Number of Participants Experiencing an Adverse Event (AE)
Hide Description The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
Time Frame Up to 73 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all non-cirrhotic randomized patients who received at least one dose of study treatment.
Arm/Group Title 24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV 24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV 48-wk Vaniprevir 300 mg + Peg-IFN/RBV 48-wk Vaniprevir 600 mg + Peg-IFN/RBV 48-wk PBO + Peg-IFN/RBV
Hide Arm/Group Description:
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Overall Number of Participants Analyzed 40 42 41 46 42
Measure Type: Number
Unit of Measure: Number of participants
38 42 40 46 41
3.Primary Outcome
Title Number of Participants Discontinuing From Study Treatment Due to AEs
Hide Description The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all randomized non-cirrhotic patients who received at least one dose of study treatment.
Arm/Group Title 24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV 24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV 48-wk Vaniprevir 300 mg + Peg-IFN/RBV 48-wk Vaniprevir 600 mg + Peg-IFN/RBV 48-wk PBO + Peg-IFN/RBV
Hide Arm/Group Description:
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Overall Number of Participants Analyzed 40 42 41 46 42
Measure Type: Number
Unit of Measure: Number of participants
2 3 2 4 1
4.Secondary Outcome
Title Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.
Hide Description The percentage of non-cirrhotic participants treated with Vaniprevir 300 mg b.i.d. with undetectable HCV RNA 24 weeks after completing treatment was determined.
Time Frame 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.
Arm/Group Title 48-wk Vaniprevir 300 mg + Peg-IFN/RBV 48-wk PBO + Peg-IFN/RBV
Hide Arm/Group Description:
Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Overall Number of Participants Analyzed 39 42
Measure Type: Number
Unit of Measure: Percentage of participants
66.7 19.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 48-wk Vaniprevir 300 mg + Peg-IFN/RBV, 48-wk PBO + Peg-IFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in percentage
Estimated Value 47.3
Confidence Interval (2-Sided) 95%
29.2 to 63.2
Estimation Comments Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.
5.Secondary Outcome
Title Percentage of Participants Achieving cEVR
Hide Description The percentage of non-cirrhotic participants with complete early viral response (cEVR; undetectable HCV RNA at Week 12) was determined for each Vaniprevir dose. Since each of the Vaniprevir 600 mg arms had the same treatment history at this point in the study, the data were pooled for analysis.
Time Frame Up to Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data. The 3 Vaniprevir 600 mg b.i.d. arms were combined in this analysis.
Arm/Group Title 24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV 48-wk Vaniprevir 300 mg + Peg-IFN/RBV PBO + Peg-IFN/RBV
Hide Arm/Group Description:
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Overall Number of Participants Analyzed 125 41 42
Measure Type: Number
Unit of Measure: Percentage of participants
92.0 85.4 9.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV, PBO + Peg-IFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in percentage
Estimated Value 82.6
Confidence Interval (2-Sided) 95%
69.5 to 90.2
Estimation Comments Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 48-wk Vaniprevir 300 mg + Peg-IFN/RBV, PBO + Peg-IFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in percentage
Estimated Value 76.1
Confidence Interval (2-Sided) 95%
60.1 to 86.7
Estimation Comments Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.
6.Secondary Outcome
Title Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.
Hide Description The percentage of participants achieving SVR24 after the 24-week Vaniprevir 600 mg b.i.d. regimen at Week 48 was compared to the control regimen.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.
Arm/Group Title 24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV 48-wk PBO + Peg-IFN/RBV
Hide Arm/Group Description:
Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Overall Number of Participants Analyzed 38 41
Measure Type: Number
Unit of Measure: Percentage of participants
71.1 36.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV, 48-wk PBO + Peg-IFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in percentage
Estimated Value 35.8
Confidence Interval (2-Sided) 95%
15.5 to 53.4
Estimation Comments Adjusted difference subtracts the percentage of PBO patients (36.6%) with undetectable HCV RNA at Week 48 and stratifies by prior treatment response.
Time Frame AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months.
Adverse Event Reporting Description AEs were monitored and presented for the combined NC and C participant populations.
 
Arm/Group Title 24-wk Vaniprevir 600 mg + Peg-IFN/RBV 24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV 48-wk Vaniprevir 300 mg + Peg-IFN/RBV 48-wk Vaniprevir 600 mg + Peg-IFN/RBV 48-wk PBO + Peg-IFN/RBV
Hide Arm/Group Description Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks. Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks. Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks. Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks. PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
All-Cause Mortality
24-wk Vaniprevir 600 mg + Peg-IFN/RBV 24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV 48-wk Vaniprevir 300 mg + Peg-IFN/RBV 48-wk Vaniprevir 600 mg + Peg-IFN/RBV 48-wk PBO + Peg-IFN/RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
24-wk Vaniprevir 600 mg + Peg-IFN/RBV 24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV 48-wk Vaniprevir 300 mg + Peg-IFN/RBV 48-wk Vaniprevir 600 mg + Peg-IFN/RBV 48-wk PBO + Peg-IFN/RBV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/56 (3.57%)      5/56 (8.93%)      6/56 (10.71%)      9/61 (14.75%)      1/56 (1.79%)    
Blood and lymphatic system disorders           
Anaemia  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/61 (0.00%)  0 0/56 (0.00%)  0
Cardiac disorders           
Cardiac failure congestive  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0
Eye disorders           
Retinal detachment  1  1/56 (1.79%)  2 0/56 (0.00%)  0 0/56 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0
Retinal vascular thorombosis  1  0/56 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0
Gastrointestinal disorders           
Upper gastrointestinal haemorrhage  1  0/56 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0
General disorders           
General physical health deterioration  1  0/56 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0
Immune system disorders           
Anaphylactic reaction  1  0/56 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0
Infections and infestations           
Arthritis infective  1  0/56 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0
Cellulitis  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0
Gastroenteritis  1  0/56 (0.00%)  0 1/56 (1.79%)  1 1/56 (1.79%)  1 0/61 (0.00%)  0 0/56 (0.00%)  0
Pneumonia  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0
Pyelonephritis  1  0/56 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0
Pyelonephritis acute  1  0/56 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0
Injury, poisoning and procedural complications           
Carbon monoxide poisoning  1  0/56 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0
Femur fracture  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/61 (0.00%)  0 0/56 (0.00%)  0
Joint dislocation  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0
Metabolism and nutrition disorders           
Hyperglycaemia  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/61 (0.00%)  0 0/56 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/56 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Malignant melanoma  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/61 (0.00%)  0 0/56 (0.00%)  0
Nervous system disorders           
Dizziness  1  0/56 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0
Syncope  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0
Psychiatric disorders           
Completed suicide  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0
Confusional state  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0
Renal and urinary disorders           
Nephrolithiasis  1  0/56 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0
Skin and subcutaneous tissue disorders           
Dermatomyositis  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/61 (0.00%)  0 0/56 (0.00%)  0
Vascular disorders           
Hypertensive crisis  1  0/56 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/61 (0.00%)  0 1/56 (1.79%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v. 15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
24-wk Vaniprevir 600 mg + Peg-IFN/RBV 24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV 48-wk Vaniprevir 300 mg + Peg-IFN/RBV 48-wk Vaniprevir 600 mg + Peg-IFN/RBV 48-wk PBO + Peg-IFN/RBV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/56 (94.64%)      56/56 (100.00%)      55/56 (98.21%)      61/61 (100.00%)      55/56 (98.21%)    
Blood and lymphatic system disorders           
Anaemia  1  8/56 (14.29%)  8 15/56 (26.79%)  23 12/56 (21.43%)  16 8/61 (13.11%)  9 8/56 (14.29%)  11
Leukopenia  1  2/56 (3.57%)  2 3/56 (5.36%)  3 1/56 (1.79%)  6 1/61 (1.64%)  1 0/56 (0.00%)  0
Neutropenia  1  9/56 (16.07%)  12 8/56 (14.29%)  14 8/56 (14.29%)  25 9/61 (14.75%)  9 3/56 (5.36%)  3
Thrombocytopenia  1  2/56 (3.57%)  2 1/56 (1.79%)  3 3/56 (5.36%)  3 3/61 (4.92%)  3 2/56 (3.57%)  2
Cardiac disorders           
Palpitations  1  2/56 (3.57%)  2 2/56 (3.57%)  2 1/56 (1.79%)  1 4/61 (6.56%)  6 1/56 (1.79%)  1
Ear and labyrinth disorders           
Vertigo  1  3/56 (5.36%)  3 2/56 (3.57%)  2 2/56 (3.57%)  2 3/61 (4.92%)  3 1/56 (1.79%)  1
Endocrine disorders           
Hypothyroidism  1  1/56 (1.79%)  1 2/56 (3.57%)  2 2/56 (3.57%)  2 4/61 (6.56%)  4 2/56 (3.57%)  2
Eye disorders           
Conjunctivitis  1  3/56 (5.36%)  4 0/56 (0.00%)  0 1/56 (1.79%)  1 2/61 (3.28%)  2 1/56 (1.79%)  2
Dry eye  1  2/56 (3.57%)  2 0/56 (0.00%)  0 5/56 (8.93%)  5 4/61 (6.56%)  4 3/56 (5.36%)  3
Gastrointestinal disorders           
Abdominal distension  1  3/56 (5.36%)  3 1/56 (1.79%)  1 2/56 (3.57%)  3 5/61 (8.20%)  5 2/56 (3.57%)  2
Abdominal pain  1  5/56 (8.93%)  5 5/56 (8.93%)  5 4/56 (7.14%)  10 8/61 (13.11%)  8 2/56 (3.57%)  2
Abdominal pain lower  1  2/56 (3.57%)  4 3/56 (5.36%)  3 1/56 (1.79%)  1 0/61 (0.00%)  0 2/56 (3.57%)  2
Abdominal pain upper  1  6/56 (10.71%)  7 9/56 (16.07%)  10 5/56 (8.93%)  6 10/61 (16.39%)  11 7/56 (12.50%)  7
Aphthous stomatitis  1  2/56 (3.57%)  2 3/56 (5.36%)  3 1/56 (1.79%)  1 1/61 (1.64%)  1 2/56 (3.57%)  2
Constipation  1  3/56 (5.36%)  4 1/56 (1.79%)  1 2/56 (3.57%)  2 3/61 (4.92%)  4 1/56 (1.79%)  1
Diarrhoea  1  23/56 (41.07%)  40 26/56 (46.43%)  34 15/56 (26.79%)  41 33/61 (54.10%)  48 9/56 (16.07%)  10
Dry mouth  1  3/56 (5.36%)  3 0/56 (0.00%)  0 3/56 (5.36%)  3 3/61 (4.92%)  3 1/56 (1.79%)  1
Dyspepsia  1  15/56 (26.79%)  20 12/56 (21.43%)  13 12/56 (21.43%)  14 7/61 (11.48%)  11 8/56 (14.29%)  9
Flatulence  1  1/56 (1.79%)  1 0/56 (0.00%)  0 3/56 (5.36%)  3 2/61 (3.28%)  2 1/56 (1.79%)  1
Gastrooesophageal reflux disease  1  8/56 (14.29%)  9 4/56 (7.14%)  5 5/56 (8.93%)  5 5/61 (8.20%)  5 2/56 (3.57%)  2
Gingivitis  1  3/56 (5.36%)  3 2/56 (3.57%)  3 1/56 (1.79%)  1 0/61 (0.00%)  0 0/56 (0.00%)  0
Haemorrhoidal haemorrhage  1  3/56 (5.36%)  4 0/56 (0.00%)  0 0/56 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0
Haemorrhoids  1  2/56 (3.57%)  3 3/56 (5.36%)  4 2/56 (3.57%)  2 2/61 (3.28%)  3 1/56 (1.79%)  2
Mouth ulceration  1  3/56 (5.36%)  3 2/56 (3.57%)  2 1/56 (1.79%)  1 5/61 (8.20%)  5 5/56 (8.93%)  5
Nausea  1  26/56 (46.43%)  31 25/56 (44.64%)  27 20/56 (35.71%)  30 39/61 (63.93%)  50 10/56 (17.86%)  10
Toothache  1  1/56 (1.79%)  1 0/56 (0.00%)  0 2/56 (3.57%)  2 2/61 (3.28%)  2 3/56 (5.36%)  3
Vomiting  1  18/56 (32.14%)  20 16/56 (28.57%)  30 8/56 (14.29%)  11 17/61 (27.87%)  26 3/56 (5.36%)  5
General disorders           
Asthenia  1  12/56 (21.43%)  12 14/56 (25.00%)  14 11/56 (19.64%)  13 13/61 (21.31%)  14 11/56 (19.64%)  12
Chest pain  1  1/56 (1.79%)  2 3/56 (5.36%)  4 0/56 (0.00%)  0 2/61 (3.28%)  2 0/56 (0.00%)  0
Chills  1  4/56 (7.14%)  4 5/56 (8.93%)  5 5/56 (8.93%)  6 2/61 (3.28%)  2 1/56 (1.79%)  1
Fatigue  1  26/56 (46.43%)  31 22/56 (39.29%)  26 25/56 (44.64%)  29 19/61 (31.15%)  19 18/56 (32.14%)  20
Feeling hot  1  0/56 (0.00%)  0 0/56 (0.00%)  0 3/56 (5.36%)  3 2/61 (3.28%)  2 0/56 (0.00%)  0
Influenza like illness  1  12/56 (21.43%)  16 10/56 (17.86%)  10 17/56 (30.36%)  18 15/61 (24.59%)  21 12/56 (21.43%)  14
Injection site erythema  1  2/56 (3.57%)  7 3/56 (5.36%)  3 3/56 (5.36%)  3 2/61 (3.28%)  3 0/56 (0.00%)  0
Injection site reaction  1  0/56 (0.00%)  0 1/56 (1.79%)  1 3/56 (5.36%)  3 1/61 (1.64%)  1 1/56 (1.79%)  1
Irritability  1  4/56 (7.14%)  5 6/56 (10.71%)  6 6/56 (10.71%)  6 8/61 (13.11%)  8 8/56 (14.29%)  8
Mucosal dryness  1  3/56 (5.36%)  3 1/56 (1.79%)  1 0/56 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0
Pain  1  2/56 (3.57%)  2 1/56 (1.79%)  2 2/56 (3.57%)  4 2/61 (3.28%)  2 4/56 (7.14%)  4
Pyrexia  1  8/56 (14.29%)  9 8/56 (14.29%)  8 9/56 (16.07%)  12 12/61 (19.67%)  13 14/56 (25.00%)  18
Hepatobiliary disorders           
Hepatomegaly  1  1/56 (1.79%)  1 3/56 (5.36%)  3 0/56 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0
Infections and infestations           
Bronchitis  1  3/56 (5.36%)  3 1/56 (1.79%)  1 2/56 (3.57%)  3 2/61 (3.28%)  2 2/56 (3.57%)  2
Nasopharyngitis  1  0/56 (0.00%)  0 6/56 (10.71%)  10 4/56 (7.14%)  5 4/61 (6.56%)  4 3/56 (5.36%)  3
Oral herpes  1  1/56 (1.79%)  2 0/56 (0.00%)  0 1/56 (1.79%)  2 3/61 (4.92%)  6 4/56 (7.14%)  6
Sinusitis  1  2/56 (3.57%)  2 2/56 (3.57%)  2 2/56 (3.57%)  2 4/61 (6.56%)  4 2/56 (3.57%)  2
Upper respiratory tract infection  1  1/56 (1.79%)  1 5/56 (8.93%)  6 3/56 (5.36%)  3 3/61 (4.92%)  5 5/56 (8.93%)  5
Injury, poisoning and procedural complications           
Excoriation  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/61 (0.00%)  0 4/56 (7.14%)  8
Investigations           
Haemoglobin decreased  1  0/56 (0.00%)  0 3/56 (5.36%)  3 1/56 (1.79%)  1 0/61 (0.00%)  0 2/56 (3.57%)  3
Weight decreased  1  3/56 (5.36%)  3 0/56 (0.00%)  0 5/56 (8.93%)  5 4/61 (6.56%)  4 1/56 (1.79%)  1
Metabolism and nutrition disorders           
Decreased appetite  1  9/56 (16.07%)  11 14/56 (25.00%)  15 9/56 (16.07%)  10 8/61 (13.11%)  8 5/56 (8.93%)  5
Musculoskeletal and connective tissue disorders           
Arthralgia  1  10/56 (17.86%)  11 8/56 (14.29%)  8 8/56 (14.29%)  10 11/61 (18.03%)  12 11/56 (19.64%)  13
Back pain  1  6/56 (10.71%)  9 6/56 (10.71%)  6 4/56 (7.14%)  4 8/61 (13.11%)  10 4/56 (7.14%)  5
Flank pain  1  0/56 (0.00%)  0 3/56 (5.36%)  3 0/56 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0
Muscle spasms  1  1/56 (1.79%)  3 3/56 (5.36%)  3 6/56 (10.71%)  7 6/61 (9.84%)  8 3/56 (5.36%)  3
Musculoskeletal pain  1  2/56 (3.57%)  2 1/56 (1.79%)  1 3/56 (5.36%)  3 5/61 (8.20%)  5 2/56 (3.57%)  2
Myalgia  1  5/56 (8.93%)  6 7/56 (12.50%)  8 15/56 (26.79%)  16 11/61 (18.03%)  11 12/56 (21.43%)  12
Neck pain  1  1/56 (1.79%)  1 3/56 (5.36%)  3 1/56 (1.79%)  1 0/61 (0.00%)  0 1/56 (1.79%)  1
Pain in extremity  1  1/56 (1.79%)  1 1/56 (1.79%)  1 2/56 (3.57%)  2 3/61 (4.92%)  3 3/56 (5.36%)  3
Nervous system disorders           
Dizziness  1  4/56 (7.14%)  6 7/56 (12.50%)  7 5/56 (8.93%)  5 7/61 (11.48%)  7 6/56 (10.71%)  6
Dysgeusia  1  5/56 (8.93%)  5 4/56 (7.14%)  4 6/56 (10.71%)  6 1/61 (1.64%)  1 3/56 (5.36%)  3
Headache  1  23/56 (41.07%)  36 18/56 (32.14%)  19 28/56 (50.00%)  40 23/61 (37.70%)  34 20/56 (35.71%)  26
Paraesthesia  1  2/56 (3.57%)  3 0/56 (0.00%)  0 4/56 (7.14%)  4 1/61 (1.64%)  1 0/56 (0.00%)  0
Psychiatric disorders           
Anxiety  1  5/56 (8.93%)  5 5/56 (8.93%)  6 2/56 (3.57%)  2 2/61 (3.28%)  2 3/56 (5.36%)  3
Depressed mood  1  1/56 (1.79%)  1 3/56 (5.36%)  4 7/56 (12.50%)  9 3/61 (4.92%)  3 4/56 (7.14%)  4
Depression  1  4/56 (7.14%)  4 7/56 (12.50%)  8 11/56 (19.64%)  11 10/61 (16.39%)  10 3/56 (5.36%)  4
Insomnia  1  7/56 (12.50%)  9 8/56 (14.29%)  10 17/56 (30.36%)  18 8/61 (13.11%)  15 14/56 (25.00%)  14
Mood swings  1  2/56 (3.57%)  2 3/56 (5.36%)  3 2/56 (3.57%)  2 1/61 (1.64%)  1 0/56 (0.00%)  0
Sleep disorder  1  7/56 (12.50%)  8 8/56 (14.29%)  8 7/56 (12.50%)  7 8/61 (13.11%)  9 4/56 (7.14%)  4
Reproductive system and breast disorders           
Erectile dysfunction  1  1/56 (1.79%)  1 0/56 (0.00%)  0 3/56 (5.36%)  3 1/61 (1.64%)  1 0/56 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Cough  1  8/56 (14.29%)  8 20/56 (35.71%)  28 9/56 (16.07%)  10 17/61 (27.87%)  19 14/56 (25.00%)  14
Dyspnoea  1  4/56 (7.14%)  4 8/56 (14.29%)  8 9/56 (16.07%)  9 9/61 (14.75%)  9 8/56 (14.29%)  8
Dyspnoea exertional  1  2/56 (3.57%)  2 5/56 (8.93%)  7 1/56 (1.79%)  1 3/61 (4.92%)  3 1/56 (1.79%)  1
Epistaxis  1  3/56 (5.36%)  3 1/56 (1.79%)  2 4/56 (7.14%)  6 3/61 (4.92%)  3 3/56 (5.36%)  4
Oropharyngeal pain  1  3/56 (5.36%)  4 1/56 (1.79%)  1 4/56 (7.14%)  4 6/61 (9.84%)  7 2/56 (3.57%)  2
Productive cough  1  3/56 (5.36%)  3 0/56 (0.00%)  0 1/56 (1.79%)  1 0/61 (0.00%)  0 0/56 (0.00%)  0
Skin and subcutaneous tissue disorders           
Alopecia  1  8/56 (14.29%)  9 6/56 (10.71%)  6 9/56 (16.07%)  9 12/61 (19.67%)  12 5/56 (8.93%)  5
Dermatitis  1  2/56 (3.57%)  2 4/56 (7.14%)  4 6/56 (10.71%)  7 3/61 (4.92%)  3 0/56 (0.00%)  0
Dry skin  1  10/56 (17.86%)  12 8/56 (14.29%)  8 9/56 (16.07%)  10 10/61 (16.39%)  10 10/56 (17.86%)  11
Eczema  1  3/56 (5.36%)  3 5/56 (8.93%)  6 6/56 (10.71%)  7 7/61 (11.48%)  7 5/56 (8.93%)  5
Hyperhidrosis  1  0/56 (0.00%)  0 3/56 (5.36%)  3 3/56 (5.36%)  3 1/61 (1.64%)  1 2/56 (3.57%)  2
Night sweats  1  0/56 (0.00%)  0 0/56 (0.00%)  0 3/56 (5.36%)  3 0/61 (0.00%)  0 1/56 (1.79%)  1
Photosensitivity reaction  1  0/56 (0.00%)  0 3/56 (5.36%)  3 0/56 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0
Pruritus  1  18/56 (32.14%)  21 19/56 (33.93%)  21 17/56 (30.36%)  23 21/61 (34.43%)  23 14/56 (25.00%)  15
Rash  1  8/56 (14.29%)  10 7/56 (12.50%)  10 8/56 (14.29%)  9 20/61 (32.79%)  22 10/56 (17.86%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v. 15.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704405     History of Changes
Other Study ID Numbers: 7009-009
2007_659 ( Other Identifier: Merck Registration Number )
First Submitted: June 23, 2008
First Posted: June 24, 2008
Results First Submitted: September 26, 2014
Results First Posted: September 29, 2014
Last Update Posted: October 9, 2018