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A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response

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ClinicalTrials.gov Identifier: NCT00758043
Recruitment Status : Completed
First Posted : September 23, 2008
Results First Posted : July 21, 2011
Last Update Posted : March 26, 2021
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: telaprevir
Drug: ribavirin
Biological: peginterferon alfa-2a
Enrollment 540
Recruitment Details  
Pre-assignment Details  
Arm/Group Title T12PR24 (eRVR+) T12PR48 (eRVR+) T12PR48 (eRVR-) Other
Hide Arm/Group Description Telaprevir + peginterferon-alfa-2a (Peg-IFN-alfa-2a) + ribavirin (RBV) for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
Period Title: Overall Study
Started 162 160 118 100
Completed 161 119 79 0
Not Completed 1 41 39 100
Reason Not Completed
Adverse Event             1             20             12             62
Lack of Efficacy             0             6             18             12
Refused Further Treatment             0             11             5             8
Lost to Follow-up             0             2             2             5
Withdrawal by Subject             0             1             1             4
Required Prohibited Medication             0             0             1             3
Non-Compliant With study Drug             0             0             0             1
Other Reasons             0             1             0             5
Arm/Group Title T12PR24 (eRVR+) T12PR48 (eRVR+) T12PR48 (eRVR-) Other Total
Hide Arm/Group Description Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen. Total of all reporting groups
Overall Number of Baseline Participants 162 160 118 100 540
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants 160 participants 118 participants 100 participants 540 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
158
  97.5%
157
  98.1%
118
 100.0%
99
  99.0%
532
  98.5%
>=65 years
4
   2.5%
3
   1.9%
0
   0.0%
1
   1.0%
8
   1.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants 160 participants 118 participants 100 participants 540 participants
48.6  (8.9) 48.3  (9.9) 49.5  (8.7) 51.6  (8.4) 49.3  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants 160 participants 118 participants 100 participants 540 participants
Female
58
  35.8%
63
  39.4%
48
  40.7%
46
  46.0%
215
  39.8%
Male
104
  64.2%
97
  60.6%
70
  59.3%
54
  54.0%
325
  60.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 162 participants 160 participants 118 participants 100 participants 540 participants
North America 154 151 106 98 509
Europe 8 9 12 2 31
1.Primary Outcome
Title Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)
Hide Description SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification [LLOQ] of 25 IU/mL).
Time Frame 24 weeks after the last planned dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.
Arm/Group Title T12PR24 (eRVR+) T12PR48 (eRVR+) T12PR48 (eRVR-) Other
Hide Arm/Group Description:
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
Overall Number of Participants Analyzed 162 160 118 100
Measure Type: Number
Unit of Measure: participants
SVR24 (Statistical Analysis 1) 149 140 76 23
SVR24 (Statistical Analysis 2) 149 144 78 27
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T12PR24 (eRVR+), T12PR48 (eRVR+)
Comments Primary efficacy analysis was based on CI estimates (using the normal approximation, confidence limits were constructed for the difference in proportions) to rule out the inferiority of the T12/PR24/eRVR+ treatment regimen relative to the T12/PR48/eRVR+ treatment regimen. SVR24 was defined as undetectable HCV RNA at end of treatment through 24 weeks after the last planned dose.
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%).
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 4.5
Confidence Interval (2-Sided) 95%
-2.1 to 11.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection T12PR24 (eRVR+), T12PR48 (eRVR+)
Comments SVR24 was defined as below the limit of quantitation at 24 weeks after the planned end of treatment. For subjects who had missing data at week 24 after the planned end of treatment, the week 12 data or the last follow-up time point after week 12 was carried forward for determining SVR24.
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%).
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
-4.3 to 8.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Subjects Who Have Undetectable HCV RNA at Week 72
Hide Description SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits.
Time Frame 72 weeks after the last planned dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.
Arm/Group Title T12PR24 (eRVR+) T12PR48 (eRVR+) T12PR48 (eRVR-) Other
Hide Arm/Group Description:
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
Overall Number of Participants Analyzed 162 160 118 100
Measure Type: Number
Unit of Measure: participants
141 140 76 20
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T12PR24 (eRVR+), T12PR48 (eRVR+)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Estimated by evaluating the treatment differences in the SVR at Week 72 planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of 10.5%).
Method of Estimation Estimation Parameter Difference in Proportion
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-7.7 to 6.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection T12PR24 (eRVR+), T12PR48 (eRVR+)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Estimated by evaluating the treatment differences in the SVR at Week 72 planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of 10.5%).
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.49 to 1.82
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
Hide Description Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment).
Time Frame Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.
Arm/Group Title T12PR24 (eRVR+) T12PR48 (eRVR+) T12PR48 (eRVR-) Other
Hide Arm/Group Description:
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
Overall Number of Participants Analyzed 162 160 118 100
Measure Type: Number
Unit of Measure: participants
162 159 0 31
4.Secondary Outcome
Title Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment
Hide Description SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment.
Time Frame 12 weeks after last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.
Arm/Group Title T12PR24 (eRVR+) T12PR48 (eRVR+) T12PR48 (eRVR-) Other
Hide Arm/Group Description:
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
Overall Number of Participants Analyzed 162 160 118 100
Measure Type: Number
Unit of Measure: participants
151 144 79 28
5.Secondary Outcome
Title Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively)
Hide Description [Not Specified]
Time Frame Week 24 or Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T12PR24 (eRVR+) T12PR48 (eRVR+) T12PR48 (eRVR-) Other
Hide Arm/Group Description:
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
Overall Number of Participants Analyzed 162 160 118 100
Measure Type: Number
Unit of Measure: participants
159 154 97 59
6.Secondary Outcome
Title Proportion of Randomized Subjects Who Relapse
Hide Description Proportion of randomized subjects who relapsed was defined as the number of subjects who completed treatment, had undetectable HCV RNA at end of treatment (EOT; Week 24 or Week 48 respectively), and became HCV RNA detectable during antiviral follow-up (24 weeks after EOT).
Time Frame From EOT to Week 48 or Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.
Arm/Group Title T12PR24 (eRVR+) T12PR48 (eRVR+) T12PR48 (eRVR-) Other
Hide Arm/Group Description:
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
Overall Number of Participants Analyzed 162 160 118 100
Measure Type: Number
Unit of Measure: participants
9 1 5 0
7.Secondary Outcome
Title Proportion of Enrolled Subjects Who Relapse
Hide Description Proportion of enrolled subjects who relapsed was defined as the number of subjects who had undetectable HCV RNA at the EOT, and became HCV RNA detectable during antiviral follow-up.
Time Frame From EOT to Week 48 or Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.
Arm/Group Title T12PR24 (eRVR+) T12PR48 (eRVR+) T12PR48 (eRVR-) Other
Hide Arm/Group Description:
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
Overall Number of Participants Analyzed 162 160 118 100
Measure Type: Number
Unit of Measure: participants
9 4 11 13
8.Secondary Outcome
Title Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame Day 1 up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included all subjects who received at least 1 dose of study drug.
Arm/Group Title T12PR24 (eRVR+) T12PR48 (eRVR+) T12PR48 (eRVR-) Other
Hide Arm/Group Description:
Telaprevir + peginterferon-alfa-2a (Peg-IFN-alfa-2a) + ribavirin (RBV) for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen
Overall Number of Participants Analyzed 162 160 118 100
Measure Type: Number
Unit of Measure: participants
Subjects With AEs 161 160 117 99
Subjects With SAEs 4 16 7 22
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title T12PR24 (eRVR+) T12PR48 (eRVR+) T12PR48 (eRVR-) Other
Hide Arm/Group Description Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
All-Cause Mortality
T12PR24 (eRVR+) T12PR48 (eRVR+) T12PR48 (eRVR-) Other
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
T12PR24 (eRVR+) T12PR48 (eRVR+) T12PR48 (eRVR-) Other
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/162 (2.47%)   16/160 (10.00%)   7/118 (5.93%)   22/100 (22.00%) 
Blood and lymphatic system disorders         
ANAEMIA  1/162 (0.62%)  4/160 (2.50%)  0/118 (0.00%)  7/100 (7.00%) 
ANAEMIA HAEMOLYTIC AUTOIMMUNE  0/162 (0.00%)  1/160 (0.63%)  0/118 (0.00%)  0/100 (0.00%) 
HAEMOLYTIC ANAEMIA  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
LYMPHOPENIA  1/162 (0.62%)  0/160 (0.00%)  0/118 (0.00%)  0/100 (0.00%) 
THROMBOCYTOPENIA  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
Cardiac disorders         
ATRIAL FIBRILLATION  0/162 (0.00%)  1/160 (0.63%)  0/118 (0.00%)  0/100 (0.00%) 
CARDIAC FAILURE CONGESTIVE  0/162 (0.00%)  1/160 (0.63%)  0/118 (0.00%)  0/100 (0.00%) 
Congenital, familial and genetic disorders         
HAEMORRHAGIC ARTERIOVENOUS MALFORMATION  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
Ear and labyrinth disorders         
VERTIGO  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
Eye disorders         
PAPILLOEDEMA  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
RETINOPATHY  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
Gastrointestinal disorders         
NAUSEA  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
PANCREATITIS ACUTE  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
VARICES OESOPHAGEAL  0/162 (0.00%)  1/160 (0.63%)  0/118 (0.00%)  0/100 (0.00%) 
General disorders         
NON-CARDIAC CHEST PAIN  0/162 (0.00%)  0/160 (0.00%)  1/118 (0.85%)  0/100 (0.00%) 
Hepatobiliary disorders         
BILE DUCT STONE  0/162 (0.00%)  1/160 (0.63%)  0/118 (0.00%)  0/100 (0.00%) 
LIVER DISORDER  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
Immune system disorders         
HYPERSENSITIVITY  0/162 (0.00%)  0/160 (0.00%)  1/118 (0.85%)  0/100 (0.00%) 
Infections and infestations         
PNEUMONIA  0/162 (0.00%)  2/160 (1.25%)  1/118 (0.85%)  0/100 (0.00%) 
APPENDICITIS  1/162 (0.62%)  0/160 (0.00%)  0/118 (0.00%)  0/100 (0.00%) 
BACTERAEMIA  0/162 (0.00%)  1/160 (0.63%)  0/118 (0.00%)  0/100 (0.00%) 
BACTERIAL INFECTION  0/162 (0.00%)  1/160 (0.63%)  0/118 (0.00%)  0/100 (0.00%) 
BURSITIS INFECTIVE  0/162 (0.00%)  0/160 (0.00%)  1/118 (0.85%)  0/100 (0.00%) 
GASTROENTERITIS  0/162 (0.00%)  0/160 (0.00%)  1/118 (0.85%)  0/100 (0.00%) 
PNEUMONIA STAPHYLOCOCCAL  0/162 (0.00%)  1/160 (0.63%)  0/118 (0.00%)  0/100 (0.00%) 
SINUSITIS  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
STAPHYLOCOCCAL INFECTION  0/162 (0.00%)  1/160 (0.63%)  0/118 (0.00%)  0/100 (0.00%) 
Injury, poisoning and procedural complications         
ALCOHOL POISONING  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
JOINT DISLOCATION  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
SPLENIC RUPTURE  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
Metabolism and nutrition disorders         
DEHYDRATION  0/162 (0.00%)  2/160 (1.25%)  0/118 (0.00%)  0/100 (0.00%) 
DIABETIC KETOACIDOSIS  0/162 (0.00%)  1/160 (0.63%)  0/118 (0.00%)  0/100 (0.00%) 
Musculoskeletal and connective tissue disorders         
POLYMYOSITIS  0/162 (0.00%)  0/160 (0.00%)  1/118 (0.85%)  0/100 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
BREAST NEOPLASM  0/162 (0.00%)  1/160 (0.63%)  0/118 (0.00%)  0/100 (0.00%) 
THROAT CANCER  1/162 (0.62%)  0/160 (0.00%)  0/118 (0.00%)  0/100 (0.00%) 
Nervous system disorders         
MIGRAINE  0/162 (0.00%)  1/160 (0.63%)  0/118 (0.00%)  0/100 (0.00%) 
Psychiatric disorders         
MANIA  0/162 (0.00%)  0/160 (0.00%)  1/118 (0.85%)  0/100 (0.00%) 
MENTAL STATUS CHANGES  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
Respiratory, thoracic and mediastinal disorders         
CRYPTOGENIC ORGANISING PNEUMONIA  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
INTERSTITIAL LUNG DISEASE  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
PULMONARY EMBOLISM  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
Skin and subcutaneous tissue disorders         
ANGIOEDEMA  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
RASH  0/162 (0.00%)  0/160 (0.00%)  0/118 (0.00%)  1/100 (1.00%) 
Vascular disorders         
DEEP VEIN THROMBOSIS  0/162 (0.00%)  1/160 (0.63%)  0/118 (0.00%)  1/100 (1.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
T12PR24 (eRVR+) T12PR48 (eRVR+) T12PR48 (eRVR-) Other
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   161/162 (99.38%)   160/160 (100.00%)   117/118 (99.15%)   99/100 (99.00%) 
Blood and lymphatic system disorders         
ANAEMIA  68/162 (41.98%)  66/160 (41.25%)  38/118 (32.20%)  40/100 (40.00%) 
NEUTROPENIA  23/162 (14.20%)  36/160 (22.50%)  31/118 (26.27%)  13/100 (13.00%) 
THROMBOCYTOPENIA  4/162 (2.47%)  6/160 (3.75%)  6/118 (5.08%)  5/100 (5.00%) 
LEUKOPENIA  4/162 (2.47%)  6/160 (3.75%)  6/118 (5.08%)  0/100 (0.00%) 
Eye disorders         
VISION BLURRED  16/162 (9.88%)  14/160 (8.75%)  12/118 (10.17%)  12/100 (12.00%) 
DRY EYE  10/162 (6.17%)  11/160 (6.88%)  5/118 (4.24%)  1/100 (1.00%) 
Gastrointestinal disorders         
CHILLS  30/162 (18.52%)  39/160 (24.38%)  19/118 (16.10%)  26/100 (26.00%) 
NAUSEA  71/162 (43.83%)  76/160 (47.50%)  61/118 (51.69%)  45/100 (45.00%) 
DIARRHOEA  48/162 (29.63%)  54/160 (33.75%)  38/118 (32.20%)  24/100 (24.00%) 
VOMITING  25/162 (15.43%)  26/160 (16.25%)  25/118 (21.19%)  20/100 (20.00%) 
ANORECTAL DISCOMFORT  35/162 (21.60%)  25/160 (15.63%)  18/118 (15.25%)  8/100 (8.00%) 
HAEMORRHOIDS  29/162 (17.90%)  23/160 (14.37%)  15/118 (12.71%)  11/100 (11.00%) 
DYSPEPSIA  18/162 (11.11%)  21/160 (13.13%)  13/118 (11.02%)  8/100 (8.00%) 
CONSTIPATION  9/162 (5.56%)  15/160 (9.38%)  11/118 (9.32%)  7/100 (7.00%) 
DRY MOUTH  10/162 (6.17%)  13/160 (8.13%)  12/118 (10.17%)  5/100 (5.00%) 
ABDOMINAL PAIN  9/162 (5.56%)  12/160 (7.50%)  8/118 (6.78%)  3/100 (3.00%) 
ABDOMINAL PAIN UPPER  10/162 (6.17%)  12/160 (7.50%)  4/118 (3.39%)  2/100 (2.00%) 
ANAL PRURITUS  4/162 (2.47%)  12/160 (7.50%)  6/118 (5.08%)  4/100 (4.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  5/162 (3.09%)  7/160 (4.38%)  7/118 (5.93%)  4/100 (4.00%) 
RECTAL HAEMORRHAGE  7/162 (4.32%)  6/160 (3.75%)  2/118 (1.69%)  6/100 (6.00%) 
TOOTHACHE  2/162 (1.23%)  5/160 (3.13%)  7/118 (5.93%)  0/100 (0.00%) 
General disorders         
FATIGUE  110/162 (67.90%)  111/160 (69.38%)  81/118 (68.64%)  67/100 (67.00%) 
INFLUENZA LIKE ILLNESS  47/162 (29.01%)  40/160 (25.00%)  33/118 (27.97%)  21/100 (21.00%) 
PYREXIA  20/162 (12.35%)  32/160 (20.00%)  22/118 (18.64%)  22/100 (22.00%) 
IRRITABILITY  30/162 (18.52%)  26/160 (16.25%)  24/118 (20.34%)  12/100 (12.00%) 
INJECTION SITE ERYTHEMA  23/162 (14.20%)  23/160 (14.37%)  18/118 (15.25%)  17/100 (17.00%) 
PAIN  14/162 (8.64%)  18/160 (11.25%)  6/118 (5.08%)  9/100 (9.00%) 
OEDEMA PERIPHERAL  7/162 (4.32%)  11/160 (6.88%)  4/118 (3.39%)  1/100 (1.00%) 
INJECTION SITE RASH  6/162 (3.70%)  7/160 (4.38%)  8/118 (6.78%)  1/100 (1.00%) 
INJECTION SITE REACTION  9/162 (5.56%)  7/160 (4.38%)  4/118 (3.39%)  2/100 (2.00%) 
MALAISE  1/162 (0.62%)  9/160 (5.63%)  1/118 (0.85%)  2/100 (2.00%) 
Infections and infestations         
SINUSITIS  6/162 (3.70%)  12/160 (7.50%)  3/118 (2.54%)  5/100 (5.00%) 
UPPER RESPIRATORY TRACT INFECTION  5/162 (3.09%)  8/160 (5.00%)  7/118 (5.93%)  2/100 (2.00%) 
NASOPHARYNGITIS  6/162 (3.70%)  4/160 (2.50%)  7/118 (5.93%)  1/100 (1.00%) 
BRONCHITIS  3/162 (1.85%)  6/160 (3.75%)  3/118 (2.54%)  5/100 (5.00%) 
URINARY TRACT INFECTION  5/162 (3.09%)  8/160 (5.00%)  3/118 (2.54%)  1/100 (1.00%) 
Investigations         
WEIGHT DECREASED  7/162 (4.32%)  15/160 (9.38%)  9/118 (7.63%)  5/100 (5.00%) 
Metabolism and nutrition disorders         
DECREASED APPETITE  16/162 (9.88%)  24/160 (15.00%)  5/118 (4.24%)  8/100 (8.00%) 
ANOREXIA  9/162 (5.56%)  12/160 (7.50%)  12/118 (10.17%)  10/100 (10.00%) 
HYPOKALAEMIA  6/162 (3.70%)  7/160 (4.38%)  7/118 (5.93%)  3/100 (3.00%) 
Musculoskeletal and connective tissue disorders         
MYALGIA  30/162 (18.52%)  27/160 (16.88%)  24/118 (20.34%)  17/100 (17.00%) 
ARTHRALGIA  21/162 (12.96%)  28/160 (17.50%)  20/118 (16.95%)  9/100 (9.00%) 
BACK PAIN  12/162 (7.41%)  20/160 (12.50%)  9/118 (7.63%)  5/100 (5.00%) 
MUSCLE SPASMS  4/162 (2.47%)  11/160 (6.88%)  6/118 (5.08%)  6/100 (6.00%) 
Nervous system disorders         
HEADACHE  61/162 (37.65%)  57/160 (35.63%)  51/118 (43.22%)  35/100 (35.00%) 
DIZZINESS  29/162 (17.90%)  30/160 (18.75%)  11/118 (9.32%)  13/100 (13.00%) 
DYSGEUSIA  18/162 (11.11%)  24/160 (15.00%)  14/118 (11.86%)  6/100 (6.00%) 
DISTURBANCE IN ATTENTION  5/162 (3.09%)  11/160 (6.88%)  9/118 (7.63%)  4/100 (4.00%) 
HYPOAESTHESIA  5/162 (3.09%)  8/160 (5.00%)  5/118 (4.24%)  4/100 (4.00%) 
PARAESTHESIA  3/162 (1.85%)  8/160 (5.00%)  6/118 (5.08%)  1/100 (1.00%) 
Psychiatric disorders         
INSOMNIA  50/162 (30.86%)  62/160 (38.75%)  44/118 (37.29%)  26/100 (26.00%) 
DEPRESSION  22/162 (13.58%)  35/160 (21.88%)  28/118 (23.73%)  22/100 (22.00%) 
ANXIETY  16/162 (9.88%)  18/160 (11.25%)  13/118 (11.02%)  17/100 (17.00%) 
SLEEP DISORDER  1/162 (0.62%)  2/160 (1.25%)  6/118 (5.08%)  0/100 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
COUGH  34/162 (20.99%)  41/160 (25.62%)  37/118 (31.36%)  15/100 (15.00%) 
DYSPNOEA  30/162 (18.52%)  40/160 (25.00%)  19/118 (16.10%)  18/100 (18.00%) 
DYSPNOEA EXERTIONAL  13/162 (8.02%)  12/160 (7.50%)  17/118 (14.41%)  7/100 (7.00%) 
PHARYNGOLARYNGEAL PAIN  10/162 (6.17%)  9/160 (5.63%)  10/118 (8.47%)  9/100 (9.00%) 
EPISTAXIS  7/162 (4.32%)  9/160 (5.63%)  5/118 (4.24%)  5/100 (5.00%) 
PRODUCTIVE COUGH  3/162 (1.85%)  10/160 (6.25%)  2/118 (1.69%)  3/100 (3.00%) 
Skin and subcutaneous tissue disorders         
PRURITUS  95/162 (58.64%)  83/160 (51.88%)  55/118 (46.61%)  40/100 (40.00%) 
RASH  60/162 (37.04%)  62/160 (38.75%)  47/118 (39.83%)  33/100 (33.00%) 
ALOPECIA  28/162 (17.28%)  49/160 (30.63%)  33/118 (27.97%)  6/100 (6.00%) 
DRY SKIN  27/162 (16.67%)  25/160 (15.63%)  24/118 (20.34%)  7/100 (7.00%) 
RASH MACULO-PAPULA  27/162 (16.67%)  17/160 (10.63%)  11/118 (9.32%)  6/100 (6.00%) 
RASH PAPULAR  19/162 (11.73%)  19/160 (11.88%)  10/118 (8.47%)  9/100 (9.00%) 
RASH ERYTHEMATOUS  10/162 (6.17%)  9/160 (5.63%)  9/118 (7.63%)  8/100 (8.00%) 
PRURITUS GENERALISED  9/162 (5.56%)  12/160 (7.50%)  5/118 (4.24%)  4/100 (4.00%) 
RASH MACULAR  8/162 (4.94%)  6/160 (3.75%)  5/118 (4.24%)  7/100 (7.00%) 
ERYTHEMA  8/162 (4.94%)  8/160 (5.00%)  4/118 (3.39%)  2/100 (2.00%) 
1
Term from vocabulary, MedDRA (11.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Kauffman, MD, PhD
Organization: Vertex Pharmaceuticals Incorporated
Phone: 617-444-6158
EMail: Robert_Kauffman@vrtx.com
Layout table for additonal information
Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00758043    
Other Study ID Numbers: VX08-950-111
EudraCT 2008-003836-39
First Submitted: September 19, 2008
First Posted: September 23, 2008
Results First Submitted: June 22, 2011
Results First Posted: July 21, 2011
Last Update Posted: March 26, 2021