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Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05101AM3)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00708500
Recruitment Status : Completed
First Posted : July 2, 2008
Results First Posted : June 15, 2011
Last Update Posted : April 7, 2017
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: Boceprevir (SCH 503034)
Biological: Pegylated interferon alfa-2b (SCH 54031)
Drug: Ribavirin (SCH 18908)
Drug: Boceprevir placebo
Enrollment 404
Recruitment Details  
Pre-assignment Details 154 participants who discontinued during the treatment phase (including those from lead in and/or boceprevir/placebo) entered the follow up phase
Arm/Group Title Placebo+PEG2b+RBV, x 44 Weeks Boceprevir+PEG2b+RBV, Response Guided Therapy Boceprevir+PEG2b+RBV, x 44 Weeks
Hide Arm/Group Description Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.

PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:

  • 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
  • 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Period Title: Treatment (Tx): 4 WEEK LEAD-IN PERIOD
Started 80 162 162
Treated With PEG2b + RBV 80 162 161
Completed 78 156 160
Not Completed 2 6 2
Reason Not Completed
Adverse Event             1             3             1
Subject withdrawal unrelated to Tx             1             0             0
Subject withdrawal related to Tx             0             1             0
Subject withdrew consent             0             2             0
Randomized but not treated             0             0             1
Period Title: Tx: RECEIVING BOCEPREVIR/PLACEBO
Started 78 156 160
Completed 23 104 105
Not Completed 55 52 55
Reason Not Completed
Adverse Event             1             10             19
Treatment Failure             49             36             29
Lost to Follow-up             0             1             0
Subject withdrawal unrelated to Tx             3             1             4
Subject withdrawal related to Tx             2             0             1
Subject withdrew consent             0             2             1
Non-compliance with protocol             0             1             1
Administrative             0             1             0
Period Title: FOLLOWUP
Started 77 151 158
Completed 37 136 143
Not Completed 40 15 15
Reason Not Completed
Adverse Event             0             1             0
Lost to Follow-up             1             6             4
Subject withdrawal unrelated to Tx             3             4             5
Subject withdrew consent             31             4             5
Non-compliance with protocol             5             0             1
Arm/Group Title Placebo+PEG2b+RBV, x 44 Weeks Boceprevir+PEG2b+RBV, Response Guided Therapy Boceprevir+PEG2b+RBV, x 44 Weeks Total
Hide Arm/Group Description Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.

PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:

  • 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
  • 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up. Total of all reporting groups
Overall Number of Baseline Participants 80 162 161 403
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 162 participants 161 participants 403 participants
52.9  (8.1) 52.9  (7.4) 52.3  (7.7) 52.7  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 162 participants 161 participants 403 participants
Female
22
  27.5%
64
  39.5%
49
  30.4%
135
  33.5%
Male
58
  72.5%
98
  60.5%
112
  69.6%
268
  66.5%
1.Primary Outcome
Title Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population.
Hide Description SVR is defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with chronic hepatitis C (CHC) genotype 1 who failed prior treatment.
Time Frame At Follow-up Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).
Arm/Group Title Placebo+PEG2b+RBV, x 44 Weeks Boceprevir+PEG2b+RBV, Response Guided Therapy Boceprevir+PEG2b+RBV, x 44 Weeks
Hide Arm/Group Description:
Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.

PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:

  • 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
  • 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 80 162 161
Measure Type: Number
Unit of Measure: Percentage of Participants
21.3 58.6 66.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo+PEG2b+RBV, x 44 Weeks, Boceprevir+PEG2b+RBV, Response Guided Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value 37.4
Confidence Interval 95%
25.7 to 49.1
Estimation Comments Difference in percentage of participants who achieved SVR: experimental minus control.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo+PEG2b+RBV, x 44 Weeks, Boceprevir+PEG2b+RBV, x 44 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value 45.2
Confidence Interval 95%
33.7 to 56.8
Estimation Comments Difference in percentage of participants who achieved SVR: experimental minus control.
2.Secondary Outcome
Title Sustained Virologic Response (SVR) Rate in the Modified Intent to Treat (mITT) Population.
Hide Description

SVR is defined as undetectable plasma HCV-RNA at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with CHC genotype 1 who failed prior treatment.

This key secondary efficacy endpoint was added as per the second protocol amendment on 02 DEC 2009.

Time Frame At Follow-up Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT = all randomized subjects who received at least one dose of boceprevir (experimental arms) or boceprevir placebo (control arm).
Arm/Group Title Placebo+PEG2b+RBV, x 44 Weeks Boceprevir+PEG2b+RBV, Response Guided Therapy Boceprevir+PEG2b+RBV, x 44 Weeks
Hide Arm/Group Description:
Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.

PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:

  • 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
  • 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 78 156 160
Measure Type: Number
Unit of Measure: Percentage of Participants
21.8 60.9 66.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo+PEG2b+RBV, x 44 Weeks, Boceprevir+PEG2b+RBV, Response Guided Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value 39.1
Confidence Interval 95%
27.2 to 51.0
Estimation Comments Difference in percentage of participants who achieved SVR: experimental minus control.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo+PEG2b+RBV, x 44 Weeks, Boceprevir+PEG2b+RBV, x 44 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value 45.1
Confidence Interval 95%
33.4 to 56.8
Estimation Comments Difference in percentage of participants who achieved SVR: experimental minus control.
3.Secondary Outcome
Title Number of Participants With Early Virologic Response.
Hide Description Having undetectable HCV-RNA at Week 2, 4, 8, or 12 was considered Early Virologic Response.
Time Frame At Week 2, 4, 8, or 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).
Arm/Group Title Placebo+PEG2b+RBV, x 44 Weeks Boceprevir+PEG2b+RBV, Response Guided Therapy Boceprevir+PEG2b+RBV, x 44 Weeks
Hide Arm/Group Description:
Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.

PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:

  • 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
  • 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 80 162 161
Measure Type: Number
Unit of Measure: participants
Week 2 0 0 0
Week 4 2 0 2
Week 8 7 74 84
Week 12 23 111 121
4.Secondary Outcome
Title Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.
Hide Description [Not Specified]
Time Frame At Follow-up Week 12 and at 72 weeks after randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).
Arm/Group Title Placebo+PEG2b+RBV, x 44 Weeks Boceprevir+PEG2b+RBV, Response Guided Therapy Boceprevir+PEG2b+RBV, x 44 Weeks
Hide Arm/Group Description:
Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.

PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:

  • 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
  • 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 80 162 161
Measure Type: Number
Unit of Measure: participants
Follow-Up Week 12 16 97 105
72 Weeks Post Randomization 17 93 105
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo+PEG2b+RBV, x 44 Weeks Boceprevir+PEG2b+RBV, Response Guided Therapy Boceprevir+PEG2b+RBV, x 44 Weeks
Hide Arm/Group Description Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.

PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:

  • 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
  • 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
All-Cause Mortality
Placebo+PEG2b+RBV, x 44 Weeks Boceprevir+PEG2b+RBV, Response Guided Therapy Boceprevir+PEG2b+RBV, x 44 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo+PEG2b+RBV, x 44 Weeks Boceprevir+PEG2b+RBV, Response Guided Therapy Boceprevir+PEG2b+RBV, x 44 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/80 (5.00%)      16/162 (9.88%)      23/161 (14.29%)    
Blood and lymphatic system disorders       
ANAEMIA  1  0/80 (0.00%)  0 0/162 (0.00%)  0 5/161 (3.11%)  5
Cardiac disorders       
ANGINA PECTORIS  1  0/80 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
ATRIAL FIBRILLATION  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
CORONARY ARTERY DISEASE  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
MYOCARDIAL INFARCTION  1  0/80 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
MYOPERICARDITIS  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
Gastrointestinal disorders       
ABDOMINAL PAIN  1  0/80 (0.00%)  0 2/162 (1.23%)  2 0/161 (0.00%)  0
CONSTIPATION  1  0/80 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
DIARRHOEA  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
GASTRITIS  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
IRRITABLE BOWEL SYNDROME  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
OESOPHAGEAL VARICES HAEMORRHAGE  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
PANCREATITIS ACUTE  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
PANCREATITIS NECROTISING  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
PEPTIC ULCER  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
General disorders       
ASTHENIA  1  0/80 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
CHEST PAIN  1  1/80 (1.25%)  1 2/162 (1.23%)  3 1/161 (0.62%)  1
OEDEMA PERIPHERAL  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
PYREXIA  1  0/80 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
Hepatobiliary disorders       
CHOLECYSTITIS  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  2
CHOLELITHIASIS  1  1/80 (1.25%)  2 0/162 (0.00%)  0 0/161 (0.00%)  0
Infections and infestations       
APPENDICITIS  1  0/80 (0.00%)  0 0/162 (0.00%)  0 3/161 (1.86%)  3
BRONCHOPNEUMONIA  1  0/80 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
CATHETER SITE INFECTION  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
GASTROENTERITIS  1  1/80 (1.25%)  1 0/162 (0.00%)  0 0/161 (0.00%)  0
GASTROENTERITIS VIRAL  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
PNEUMONIA  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
Injury, poisoning and procedural complications       
LOWER LIMB FRACTURE  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
OVERDOSE  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
Metabolism and nutrition disorders       
DECREASED APPETITE  1  0/80 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
DEHYDRATION  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
HYPERGLYCAEMIA  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
Musculoskeletal and connective tissue disorders       
BACK PAIN  1  0/80 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
INTERVERTEBRAL DISC PROTRUSION  1  0/80 (0.00%)  0 2/162 (1.23%)  2 0/161 (0.00%)  0
PAIN IN EXTREMITY  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
HEPATIC NEOPLASM MALIGNANT  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
Nervous system disorders       
HEPATIC ENCEPHALOPATHY  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
PARKINSONISM  1  1/80 (1.25%)  1 0/162 (0.00%)  0 0/161 (0.00%)  0
SCIATICA  1  0/80 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
SYNCOPE  1  0/80 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
Psychiatric disorders       
BIPOLAR DISORDER  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
COMPLETED SUICIDE  1  0/80 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
DEPRESSION  1  0/80 (0.00%)  0 3/162 (1.85%)  3 1/161 (0.62%)  1
HOMICIDAL IDEATION  1  0/80 (0.00%)  0 1/162 (0.62%)  1 1/161 (0.62%)  1
SUICIDAL IDEATION  1  0/80 (0.00%)  0 3/162 (1.85%)  3 2/161 (1.24%)  2
Respiratory, thoracic and mediastinal disorders       
DYSPNOEA  1  0/80 (0.00%)  0 2/162 (1.23%)  2 0/161 (0.00%)  0
PLEURITIC PAIN  1  0/80 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
PNEUMOTHORAX  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
Surgical and medical procedures       
ABDOMINAL HERNIA REPAIR  1  0/80 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
Vascular disorders       
DEEP VEIN THROMBOSIS  1  0/80 (0.00%)  0 0/162 (0.00%)  0 1/161 (0.62%)  1
PHLEBITIS  1  0/80 (0.00%)  0 1/162 (0.62%)  1 0/161 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo+PEG2b+RBV, x 44 Weeks Boceprevir+PEG2b+RBV, Response Guided Therapy Boceprevir+PEG2b+RBV, x 44 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   77/80 (96.25%)      159/162 (98.15%)      160/161 (99.38%)    
Blood and lymphatic system disorders       
ANAEMIA  1  16/80 (20.00%)  20 70/162 (43.21%)  117 75/161 (46.58%)  125
LEUKOPENIA  1  1/80 (1.25%)  3 4/162 (2.47%)  12 11/161 (6.83%)  18
NEUTROPENIA  1  8/80 (10.00%)  12 23/162 (14.20%)  60 23/161 (14.29%)  43
THROMBOCYTOPENIA  1  0/80 (0.00%)  0 2/162 (1.23%)  4 10/161 (6.21%)  12
Gastrointestinal disorders       
ABDOMINAL PAIN  1  8/80 (10.00%)  8 4/162 (2.47%)  4 11/161 (6.83%)  12
ABDOMINAL PAIN UPPER  1  2/80 (2.50%)  2 14/162 (8.64%)  23 12/161 (7.45%)  16
CONSTIPATION  1  6/80 (7.50%)  6 15/162 (9.26%)  17 19/161 (11.80%)  22
DIARRHOEA  1  13/80 (16.25%)  21 38/162 (23.46%)  59 40/161 (24.84%)  59
DRY MOUTH  1  7/80 (8.75%)  8 21/162 (12.96%)  25 26/161 (16.15%)  32
DYSPEPSIA  1  5/80 (6.25%)  5 11/162 (6.79%)  16 10/161 (6.21%)  13
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/80 (0.00%)  0 9/162 (5.56%)  9 9/161 (5.59%)  9
NAUSEA  1  30/80 (37.50%)  37 72/162 (44.44%)  89 68/161 (42.24%)  99
STOMATITIS  1  2/80 (2.50%)  2 10/162 (6.17%)  11 5/161 (3.11%)  6
VOMITING  1  6/80 (7.50%)  6 23/162 (14.20%)  27 24/161 (14.91%)  33
General disorders       
ASTHENIA  1  13/80 (16.25%)  20 30/162 (18.52%)  43 38/161 (23.60%)  59
CHILLS  1  24/80 (30.00%)  36 56/162 (34.57%)  94 50/161 (31.06%)  63
FATIGUE  1  40/80 (50.00%)  59 87/162 (53.70%)  137 92/161 (57.14%)  115
INFLUENZA LIKE ILLNESS  1  20/80 (25.00%)  20 41/162 (25.31%)  51 38/161 (23.60%)  44
INJECTION SITE ERYTHEMA  1  7/80 (8.75%)  17 22/162 (13.58%)  24 16/161 (9.94%)  33
INJECTION SITE REACTION  1  7/80 (8.75%)  10 9/162 (5.56%)  12 16/161 (9.94%)  17
IRRITABILITY  1  10/80 (12.50%)  13 31/162 (19.14%)  38 36/161 (22.36%)  41
PAIN  1  3/80 (3.75%)  5 11/162 (6.79%)  12 15/161 (9.32%)  15
PYREXIA  1  20/80 (25.00%)  32 45/162 (27.78%)  58 48/161 (29.81%)  67
Infections and infestations       
BRONCHITIS  1  6/80 (7.50%)  6 3/162 (1.85%)  5 6/161 (3.73%)  7
NASOPHARYNGITIS  1  6/80 (7.50%)  9 5/162 (3.09%)  6 4/161 (2.48%)  4
SINUSITIS  1  7/80 (8.75%)  7 7/162 (4.32%)  10 4/161 (2.48%)  5
Investigations       
WEIGHT DECREASED  1  7/80 (8.75%)  8 21/162 (12.96%)  27 15/161 (9.32%)  19
Metabolism and nutrition disorders       
DECREASED APPETITE  1  13/80 (16.25%)  15 37/162 (22.84%)  38 46/161 (28.57%)  56
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  13/80 (16.25%)  15 34/162 (20.99%)  36 39/161 (24.22%)  53
BACK PAIN  1  5/80 (6.25%)  7 13/162 (8.02%)  16 14/161 (8.70%)  15
MYALGIA  1  19/80 (23.75%)  28 46/162 (28.40%)  82 35/161 (21.74%)  42
PAIN IN EXTREMITY  1  4/80 (5.00%)  4 3/162 (1.85%)  4 10/161 (6.21%)  13
Nervous system disorders       
DISTURBANCE IN ATTENTION  1  6/80 (7.50%)  7 11/162 (6.79%)  11 12/161 (7.45%)  17
DIZZINESS  1  8/80 (10.00%)  8 26/162 (16.05%)  29 26/161 (16.15%)  36
DYSGEUSIA  1  9/80 (11.25%)  9 70/162 (43.21%)  79 72/161 (44.72%)  86
HEADACHE  1  39/80 (48.75%)  50 69/162 (42.59%)  95 64/161 (39.75%)  82
MEMORY IMPAIRMENT  1  4/80 (5.00%)  5 10/162 (6.17%)  10 5/161 (3.11%)  5
Psychiatric disorders       
ANXIETY  1  6/80 (7.50%)  7 19/162 (11.73%)  25 20/161 (12.42%)  23
DEPRESSION  1  12/80 (15.00%)  12 18/162 (11.11%)  21 28/161 (17.39%)  39
INSOMNIA  1  19/80 (23.75%)  33 50/162 (30.86%)  65 47/161 (29.19%)  62
Respiratory, thoracic and mediastinal disorders       
COUGH  1  14/80 (17.50%)  20 30/162 (18.52%)  36 40/161 (24.84%)  59
DYSPNOEA  1  14/80 (17.50%)  14 29/162 (17.90%)  42 40/161 (24.84%)  46
DYSPNOEA EXERTIONAL  1  4/80 (5.00%)  4 22/162 (13.58%)  23 14/161 (8.70%)  14
EPISTAXIS  1  4/80 (5.00%)  4 10/162 (6.17%)  11 7/161 (4.35%)  9
OROPHARYNGEAL PAIN  1  5/80 (6.25%)  5 7/162 (4.32%)  8 9/161 (5.59%)  9
PRODUCTIVE COUGH  1  2/80 (2.50%)  2 4/162 (2.47%)  4 11/161 (6.83%)  12
Skin and subcutaneous tissue disorders       
ALOPECIA  1  13/80 (16.25%)  14 42/162 (25.93%)  44 29/161 (18.01%)  30
DRY SKIN  1  7/80 (8.75%)  11 35/162 (21.60%)  40 37/161 (22.98%)  45
PRURITUS  1  14/80 (17.50%)  17 31/162 (19.14%)  41 31/161 (19.25%)  47
RASH  1  5/80 (6.25%)  6 27/162 (16.67%)  32 24/161 (14.91%)  40
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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.
Investigator may not publish/publicly present interim results without prior consent of Sponsor. Any materials that report results of the study must be sent to Sponsor 45 days prior to submission for publication/presentation. Sponsor has right to review and comment. In case of any disagreements concerning appropriateness of the materials, investigator and Sponsor must meet to make a good faith effort to discuss/resolve the issues or disagreement, prior to submission for publication/presentation.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00708500     History of Changes
Other Study ID Numbers: P05101
2007-005151-42
First Submitted: June 27, 2008
First Posted: July 2, 2008
Results First Submitted: May 13, 2011
Results First Posted: June 15, 2011
Last Update Posted: April 7, 2017