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Trial record 54 of 540 for:    IFNA2 AND RBV AND IFN alfa-2

Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C

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ClinicalTrials.gov Identifier: NCT00336479
Recruitment Status : Completed
First Posted : June 13, 2006
Results First Posted : July 21, 2011
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: Telaprevir
Drug: Ribavirin
Drug: Pegylated Interferon Alfa 2a
Other: Placebo
Enrollment 263
Recruitment Details  
Pre-assignment Details A total of 263 subjects were enrolled, of which 13 subjects discontinued the study prior to study drug administration. A total of 250 subjects started treatment.
Arm/Group Title PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Hide Arm/Group Description Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
Period Title: Overall Study
Started 75 79 79 17
Completed 38 54 53 13
Not Completed 37 25 26 4
Reason Not Completed
Adverse Event             8             11             18             4
Noncompliant             1             7             3             0
Physician Decision             2             3             1             0
Lost to Follow-up             3             2             0             0
Withdrawal by Subject             3             2             3             0
Other             0             0             1             0
Virologic Stopping Rule             20             0             0             0
Arm/Group Title PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Total
Hide Arm/Group Description Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 75 79 79 17 250
Hide Baseline Analysis Population Description
The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 79 participants 79 participants 17 participants 250 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
75
 100.0%
79
 100.0%
79
 100.0%
17
 100.0%
250
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 79 participants 79 participants 17 participants 250 participants
46.8  (8.7) 48.7  (7.4) 48.4  (7.6) 49.1  (8.0) 48.1  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 79 participants 79 participants 17 participants 250 participants
Female
32
  42.7%
31
  39.2%
25
  31.6%
5
  29.4%
93
  37.2%
Male
43
  57.3%
48
  60.8%
54
  68.4%
12
  70.6%
157
  62.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
North America Number Analyzed 75 participants 79 participants 79 participants 17 participants 250 participants
75 79 79 17 250
1.Primary Outcome
Title Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing
Hide Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Time Frame 24 weeks after the completion of study drug dosing (up to Week 72)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.
Arm/Group Title PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Hide Arm/Group Description:
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
Overall Number of Participants Analyzed 75 79 79 17
Measure Type: Number
Unit of Measure: percentage of participants
41.3 67.1 60.8 35.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Regression, Logistic
Comments Treatment, weight, race and baseline HCV RNA as factors
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.985
Confidence Interval (2-Sided) 95%
1.525 to 5.842
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0204
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.170
Confidence Interval (2-Sided) 95%
1.127 to 4.178
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing
Hide Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Time Frame 12 weeks after the completion of study drug dosing (up to Week 60)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.
Arm/Group Title PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Hide Arm/Group Description:
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
Overall Number of Participants Analyzed 75 79 79 17
Measure Type: Number
Unit of Measure: percentage of participants
36.0 58.2 53.2 35.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0051
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.586
Confidence Interval (2-Sided) 95%
1.331 to 5.025
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0418
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.976
Confidence Interval (2-Sided) 95%
1.026 to 3.807
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description AE: any adverse change from the subject’s baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. “Study drug” includes all investigational agents (including placebo, if applicable) administered during the course of the study.
Time Frame Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.
Arm/Group Title PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Hide Arm/Group Description:
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
Overall Number of Participants Analyzed 75 79 79 17
Measure Type: Number
Unit of Measure: participants
AEs 75 79 79 17
SAEs 4 5 10 3
4.Secondary Outcome
Title Number of Subjects With Viral Relapse
Hide Description Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Time Frame After last dose of study drug up to antiviral follow-up (up to Week 72)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).
Arm/Group Title PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Hide Arm/Group Description:
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
Overall Number of Participants Analyzed 35 51 41 9
Measure Type: Number
Unit of Measure: participants
8 3 1 3
5.Secondary Outcome
Title Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Hide Description Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.
Time Frame Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.
Arm/Group Title Telaprevir
Hide Arm/Group Description:
All Subjects from “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week”, “Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week”, and “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week” reporting groups who received single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks.
Overall Number of Participants Analyzed 175
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Cmax 3032.48  (756.93)
Cmin 2235.51  (618.37)
Cavg 2738.46  (699.06)
Time Frame AEs and SAEs During Dosing From Baseline to Week 48
Adverse Event Reporting Description In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
 
Arm/Group Title PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Hide Arm/Group Description Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
All-Cause Mortality
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/75 (5.33%)   5/79 (6.33%)   10/79 (12.66%)   3/17 (17.65%) 
Blood and lymphatic system disorders         
ANAEMIA  1  0/75 (0.00%)  0/79 (0.00%)  1/79 (1.27%)  1/17 (5.88%) 
LYMPHADENITIS  1  1/75 (1.33%)  0/79 (0.00%)  0/79 (0.00%)  0/17 (0.00%) 
PANCYTOPENIA  1  1/75 (1.33%)  0/79 (0.00%)  0/79 (0.00%)  0/17 (0.00%) 
Cardiac disorders         
ACUTE MYOCARDIAL INFARCTION  1  0/75 (0.00%)  0/79 (0.00%)  1/79 (1.27%)  0/17 (0.00%) 
Ear and labyrinth disorders         
DEAFNESS NEUROSENSORY  1  1/75 (1.33%)  0/79 (0.00%)  0/79 (0.00%)  0/17 (0.00%) 
Endocrine disorders         
ADRENAL DISORDER  1  0/75 (0.00%)  0/79 (0.00%)  1/79 (1.27%)  0/17 (0.00%) 
Eye disorders         
SCOTOMA  1  0/75 (0.00%)  1/79 (1.27%)  0/79 (0.00%)  1/17 (5.88%) 
RETINAL EXUDATES  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
RETINAL INFARCTION  1  0/75 (0.00%)  1/79 (1.27%)  0/79 (0.00%)  0/17 (0.00%) 
Gastrointestinal disorders         
COLITIS ISCHAEMIC  1  0/75 (0.00%)  0/79 (0.00%)  1/79 (1.27%)  0/17 (0.00%) 
General disorders         
NON-CARDIAC CHEST PAIN  1  0/75 (0.00%)  0/79 (0.00%)  1/79 (1.27%)  0/17 (0.00%) 
Infections and infestations         
BRONCHITIS BACTERIAL  1  0/75 (0.00%)  1/79 (1.27%)  0/79 (0.00%)  0/17 (0.00%) 
FURUNCLE  1  0/75 (0.00%)  0/79 (0.00%)  1/79 (1.27%)  0/17 (0.00%) 
GASTROENTERITIS  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
LOBAR PNEUMONIA  1  1/75 (1.33%)  0/79 (0.00%)  0/79 (0.00%)  0/17 (0.00%) 
Injury, poisoning and procedural complications         
INCISIONAL HERNIA  1  0/75 (0.00%)  1/79 (1.27%)  0/79 (0.00%)  0/17 (0.00%) 
Metabolism and nutrition disorders         
DEHYDRATION  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
Nervous system disorders         
LUMBAR RADICULOPATHY  1  0/75 (0.00%)  1/79 (1.27%)  0/79 (0.00%)  0/17 (0.00%) 
Psychiatric disorders         
DEPRESSION  1  0/75 (0.00%)  1/79 (1.27%)  1/79 (1.27%)  0/17 (0.00%) 
ANXIETY  1  1/75 (1.33%)  0/79 (0.00%)  0/79 (0.00%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  0/75 (0.00%)  1/79 (1.27%)  0/79 (0.00%)  0/17 (0.00%) 
Skin and subcutaneous tissue disorders         
EXFOLIATIVE RASH  1  0/75 (0.00%)  0/79 (0.00%)  1/79 (1.27%)  0/17 (0.00%) 
RASH  1  0/75 (0.00%)  0/79 (0.00%)  1/79 (1.27%)  0/17 (0.00%) 
RASH GENERALISED  1  0/75 (0.00%)  0/79 (0.00%)  1/79 (1.27%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   75/75 (100.00%)   79/79 (100.00%)   79/79 (100.00%)   17/17 (100.00%) 
Blood and lymphatic system disorders         
ANAEMIA  1  20/75 (26.67%)  23/79 (29.11%)  29/79 (36.71%)  6/17 (35.29%) 
NEUTROPENIA  1  18/75 (24.00%)  19/79 (24.05%)  11/79 (13.92%)  0/17 (0.00%) 
Cardiac disorders         
PALPITATIONS  1  3/75 (4.00%)  2/79 (2.53%)  0/79 (0.00%)  1/17 (5.88%) 
Ear and labyrinth disorders         
TINNITUS  1  4/75 (5.33%)  0/79 (0.00%)  6/79 (7.59%)  0/17 (0.00%) 
VERTIGO  1  2/75 (2.67%)  2/79 (2.53%)  2/79 (2.53%)  1/17 (5.88%) 
Eye disorders         
VISION BLURRED  1  6/75 (8.00%)  14/79 (17.72%)  10/79 (12.66%)  3/17 (17.65%) 
DRY EYE  1  3/75 (4.00%)  3/79 (3.80%)  4/79 (5.06%)  1/17 (5.88%) 
PHOTOPHOBIA  1  1/75 (1.33%)  4/79 (5.06%)  1/79 (1.27%)  1/17 (5.88%) 
CONJUNCTIVITIS  1  1/75 (1.33%)  0/79 (0.00%)  1/79 (1.27%)  2/17 (11.76%) 
EYE PRURITUS  1  2/75 (2.67%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
VITREOUS FLOATERS  1  0/75 (0.00%)  2/79 (2.53%)  0/79 (0.00%)  1/17 (5.88%) 
LACRIMATION INCREASED  1  0/75 (0.00%)  1/79 (1.27%)  0/79 (0.00%)  1/17 (5.88%) 
OCULAR ICTERUS  1  1/75 (1.33%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
SCOTOMA  1  0/75 (0.00%)  1/79 (1.27%)  0/79 (0.00%)  1/17 (5.88%) 
CATARACT  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
RETINAL EXUDATES  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
Gastrointestinal disorders         
NAUSEA  1  22/75 (29.33%)  38/79 (48.10%)  44/79 (55.70%)  11/17 (64.71%) 
DIARRHOEA  1  21/75 (28.00%)  27/79 (34.18%)  33/79 (41.77%)  4/17 (23.53%) 
VOMITING  1  9/75 (12.00%)  16/79 (20.25%)  19/79 (24.05%)  3/17 (17.65%) 
HAEMORRHOIDS  1  1/75 (1.33%)  13/79 (16.46%)  10/79 (12.66%)  4/17 (23.53%) 
DYSPEPSIA  1  7/75 (9.33%)  8/79 (10.13%)  7/79 (8.86%)  1/17 (5.88%) 
DRY MOUTH  1  5/75 (6.67%)  8/79 (10.13%)  8/79 (10.13%)  1/17 (5.88%) 
CONSTIPATION  1  4/75 (5.33%)  8/79 (10.13%)  6/79 (7.59%)  0/17 (0.00%) 
ABDOMINAL PAIN UPPER  1  6/75 (8.00%)  4/79 (5.06%)  6/79 (7.59%)  0/17 (0.00%) 
ABDOMINAL PAIN  1  5/75 (6.67%)  3/79 (3.80%)  6/79 (7.59%)  0/17 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  6/75 (8.00%)  1/79 (1.27%)  5/79 (6.33%)  2/17 (11.76%) 
FLATULENCE  1  3/75 (4.00%)  6/79 (7.59%)  3/79 (3.80%)  1/17 (5.88%) 
ANAL DISCOMFORT  1  2/75 (2.67%)  3/79 (3.80%)  6/79 (7.59%)  1/17 (5.88%) 
STOMACH DISCOMFORT  1  6/75 (8.00%)  1/79 (1.27%)  4/79 (5.06%)  0/17 (0.00%) 
ABDOMINAL DISTENSION  1  4/75 (5.33%)  2/79 (2.53%)  4/79 (5.06%)  0/17 (0.00%) 
RECTAL HAEMORRHAGE  1  1/75 (1.33%)  5/79 (6.33%)  4/79 (5.06%)  0/17 (0.00%) 
APHTHOUS STOMATITIS  1  3/75 (4.00%)  2/79 (2.53%)  2/79 (2.53%)  1/17 (5.88%) 
FREQUENT BOWEL MOVEMENTS  1  2/75 (2.67%)  2/79 (2.53%)  4/79 (5.06%)  0/17 (0.00%) 
PAINFUL DEFAECATION  1  0/75 (0.00%)  1/79 (1.27%)  4/79 (5.06%)  1/17 (5.88%) 
PRURITUS ANI  1  0/75 (0.00%)  1/79 (1.27%)  4/79 (5.06%)  1/17 (5.88%) 
CHAPPED LIPS  1  2/75 (2.67%)  1/79 (1.27%)  1/79 (1.27%)  1/17 (5.88%) 
GINGIVAL PAIN  1  1/75 (1.33%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
LOOSE TOOTH  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
UMBILICAL HERNIA  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
General disorders         
FATIGUE  1  57/75 (76.00%)  58/79 (73.42%)  55/79 (69.62%)  14/17 (82.35%) 
INFLUENZA LIKE ILLNESS  1  32/75 (42.67%)  30/79 (37.97%)  39/79 (49.37%)  6/17 (35.29%) 
INJECTION SITE ERYTHEMA  1  18/75 (24.00%)  25/79 (31.65%)  22/79 (27.85%)  6/17 (35.29%) 
PYREXIA  1  22/75 (29.33%)  15/79 (18.99%)  16/79 (20.25%)  2/17 (11.76%) 
IRRITABILITY  1  22/75 (29.33%)  8/79 (10.13%)  13/79 (16.46%)  2/17 (11.76%) 
CHILLS  1  14/75 (18.67%)  18/79 (22.78%)  8/79 (10.13%)  3/17 (17.65%) 
PAIN  1  15/75 (20.00%)  6/79 (7.59%)  9/79 (11.39%)  1/17 (5.88%) 
PHARMACEUTICAL PRODUCT COMPLAINT  1  2/75 (2.67%)  8/79 (10.13%)  4/79 (5.06%)  1/17 (5.88%) 
NON-CARDIAC CHEST PAIN  1  2/75 (2.67%)  1/79 (1.27%)  5/79 (6.33%)  0/17 (0.00%) 
OEDEMA PERIPHERAL  1  0/75 (0.00%)  3/79 (3.80%)  4/79 (5.06%)  0/17 (0.00%) 
FEELING HOT  1  0/75 (0.00%)  4/79 (5.06%)  2/79 (2.53%)  0/17 (0.00%) 
MALAISE  1  1/75 (1.33%)  0/79 (0.00%)  2/79 (2.53%)  1/17 (5.88%) 
Hepatobiliary disorders         
JAUNDICE  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
Infections and infestations         
SINUSITIS  1  7/75 (9.33%)  4/79 (5.06%)  4/79 (5.06%)  1/17 (5.88%) 
UPPER RESPIRATORY TRACT INFECTION  1  1/75 (1.33%)  6/79 (7.59%)  5/79 (6.33%)  0/17 (0.00%) 
NASOPHARYNGITIS  1  4/75 (5.33%)  2/79 (2.53%)  2/79 (2.53%)  1/17 (5.88%) 
CELLULITIS  1  0/75 (0.00%)  2/79 (2.53%)  2/79 (2.53%)  1/17 (5.88%) 
GASTROENTERITIS  1  0/75 (0.00%)  0/79 (0.00%)  1/79 (1.27%)  1/17 (5.88%) 
LOCALISED INFECTION  1  0/75 (0.00%)  1/79 (1.27%)  0/79 (0.00%)  1/17 (5.88%) 
PHARYNGITIS STREPTOCOCCAL  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
Injury, poisoning and procedural complications         
SKIN LACERATION  1  1/75 (1.33%)  1/79 (1.27%)  1/79 (1.27%)  1/17 (5.88%) 
ARTHROPOD STING  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
CONTACT LENS COMPLICATION  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
Investigations         
HAEMOGLOBIN DECREASED  1  2/75 (2.67%)  4/79 (5.06%)  4/79 (5.06%)  1/17 (5.88%) 
BLOOD PRESSURE INCREASED  1  1/75 (1.33%)  0/79 (0.00%)  2/79 (2.53%)  1/17 (5.88%) 
WEIGHT DECREASED  1  0/75 (0.00%)  1/79 (1.27%)  0/79 (0.00%)  1/17 (5.88%) 
Metabolism and nutrition disorders         
DECREASED APPETITE  1  9/75 (12.00%)  11/79 (13.92%)  10/79 (12.66%)  1/17 (5.88%) 
HYPERTRIGLYCERIDAEMIA  1  1/75 (1.33%)  3/79 (3.80%)  4/79 (5.06%)  0/17 (0.00%) 
ANOREXIA  1  4/75 (5.33%)  0/79 (0.00%)  2/79 (2.53%)  1/17 (5.88%) 
DEHYDRATION  1  0/75 (0.00%)  0/79 (0.00%)  5/79 (6.33%)  1/17 (5.88%) 
HYPERURICAEMIA  1  0/75 (0.00%)  0/79 (0.00%)  4/79 (5.06%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  16/75 (21.33%)  17/79 (21.52%)  13/79 (16.46%)  4/17 (23.53%) 
MYALGIA  1  18/75 (24.00%)  15/79 (18.99%)  9/79 (11.39%)  3/17 (17.65%) 
BACK PAIN  1  12/75 (16.00%)  8/79 (10.13%)  6/79 (7.59%)  2/17 (11.76%) 
MUSCLE SPASMS  1  5/75 (6.67%)  7/79 (8.86%)  8/79 (10.13%)  1/17 (5.88%) 
PAIN IN EXTREMITY  1  7/75 (9.33%)  4/79 (5.06%)  4/79 (5.06%)  2/17 (11.76%) 
BUTTOCK PAIN  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
MUSCULOSKELETAL DISCOMFORT  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
Nervous system disorders         
HEADACHE  1  45/75 (60.00%)  34/79 (43.04%)  37/79 (46.84%)  9/17 (52.94%) 
DIZZINESS  1  14/75 (18.67%)  15/79 (18.99%)  22/79 (27.85%)  4/17 (23.53%) 
DYSGEUSIA  1  8/75 (10.67%)  8/79 (10.13%)  8/79 (10.13%)  0/17 (0.00%) 
DISTURBANCE IN ATTENTION  1  7/75 (9.33%)  6/79 (7.59%)  4/79 (5.06%)  3/17 (17.65%) 
MEMORY IMPAIRMENT  1  7/75 (9.33%)  2/79 (2.53%)  7/79 (8.86%)  0/17 (0.00%) 
TREMOR  1  1/75 (1.33%)  3/79 (3.80%)  3/79 (3.80%)  1/17 (5.88%) 
HYPOAESTHESIA  1  1/75 (1.33%)  1/79 (1.27%)  4/79 (5.06%)  1/17 (5.88%) 
HYPERAESTHESIA  1  0/75 (0.00%)  4/79 (5.06%)  2/79 (2.53%)  0/17 (0.00%) 
PARAESTHESIA  1  2/75 (2.67%)  1/79 (1.27%)  2/79 (2.53%)  1/17 (5.88%) 
SOMNOLENCE  1  1/75 (1.33%)  1/79 (1.27%)  0/79 (0.00%)  2/17 (11.76%) 
PAROSMIA  1  2/75 (2.67%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
POOR QUALITY SLEEP  1  1/75 (1.33%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
COGNITIVE DISORDER  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
MENTAL IMPAIRMENT  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
TENSION HEADACHE  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
Psychiatric disorders         
INSOMNIA  1  29/75 (38.67%)  27/79 (34.18%)  35/79 (44.30%)  6/17 (35.29%) 
DEPRESSION  1  13/75 (17.33%)  15/79 (18.99%)  17/79 (21.52%)  2/17 (11.76%) 
ANXIETY  1  13/75 (17.33%)  11/79 (13.92%)  6/79 (7.59%)  3/17 (17.65%) 
MOOD SWINGS  1  3/75 (4.00%)  5/79 (6.33%)  2/79 (2.53%)  1/17 (5.88%) 
LIBIDO DECREASED  1  2/75 (2.67%)  4/79 (5.06%)  1/79 (1.27%)  0/17 (0.00%) 
TEARFULNESS  1  0/75 (0.00%)  2/79 (2.53%)  1/79 (1.27%)  1/17 (5.88%) 
AGITATION  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
Renal and urinary disorders         
POLLAKIURIA  1  2/75 (2.67%)  3/79 (3.80%)  5/79 (6.33%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
COUGH  1  14/75 (18.67%)  16/79 (20.25%)  17/79 (21.52%)  3/17 (17.65%) 
DYSPNOEA  1  11/75 (14.67%)  10/79 (12.66%)  12/79 (15.19%)  3/17 (17.65%) 
DYSPNOEA EXERTIONAL  1  8/75 (10.67%)  5/79 (6.33%)  4/79 (5.06%)  3/17 (17.65%) 
PHARYNGOLARYNGEAL PAIN  1  8/75 (10.67%)  3/79 (3.80%)  5/79 (6.33%)  1/17 (5.88%) 
NASAL CONGESTION  1  5/75 (6.67%)  6/79 (7.59%)  5/79 (6.33%)  0/17 (0.00%) 
SINUS CONGESTION  1  5/75 (6.67%)  6/79 (7.59%)  2/79 (2.53%)  0/17 (0.00%) 
Skin and subcutaneous tissue disorders         
PRURITUS  1  17/75 (22.67%)  32/79 (40.51%)  38/79 (48.10%)  4/17 (23.53%) 
RASH  1  20/75 (26.67%)  32/79 (40.51%)  24/79 (30.38%)  6/17 (35.29%) 
DRY SKIN  1  19/75 (25.33%)  13/79 (16.46%)  14/79 (17.72%)  1/17 (5.88%) 
RASH GENERALISED  1  4/75 (5.33%)  9/79 (11.39%)  18/79 (22.78%)  3/17 (17.65%) 
ALOPECIA  1  8/75 (10.67%)  13/79 (16.46%)  8/79 (10.13%)  0/17 (0.00%) 
PRURITUS GENERALISED  1  0/75 (0.00%)  14/79 (17.72%)  8/79 (10.13%)  3/17 (17.65%) 
HYPOTRICHOSIS  1  7/75 (9.33%)  8/79 (10.13%)  6/79 (7.59%)  0/17 (0.00%) 
ERYTHEMA  1  3/75 (4.00%)  6/79 (7.59%)  4/79 (5.06%)  0/17 (0.00%) 
HYPERHIDROSIS  1  8/75 (10.67%)  4/79 (5.06%)  1/79 (1.27%)  0/17 (0.00%) 
RASH ERYTHEMATOUS  1  3/75 (4.00%)  2/79 (2.53%)  6/79 (7.59%)  0/17 (0.00%) 
RASH MACULO-PAPULAR  1  3/75 (4.00%)  2/79 (2.53%)  3/79 (3.80%)  3/17 (17.65%) 
RASH PAPULAR  1  3/75 (4.00%)  4/79 (5.06%)  2/79 (2.53%)  1/17 (5.88%) 
RASH PRURITIC  1  2/75 (2.67%)  3/79 (3.80%)  5/79 (6.33%)  0/17 (0.00%) 
INCREASED TENDENCY TO BRUISE  1  2/75 (2.67%)  3/79 (3.80%)  3/79 (3.80%)  1/17 (5.88%) 
NIGHT SWEATS  1  3/75 (4.00%)  4/79 (5.06%)  2/79 (2.53%)  0/17 (0.00%) 
RASH MACULAR  1  2/75 (2.67%)  2/79 (2.53%)  4/79 (5.06%)  0/17 (0.00%) 
ECZEMA ASTEATOTIC  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
STASIS DERMATITIS  1  0/75 (0.00%)  0/79 (0.00%)  0/79 (0.00%)  1/17 (5.88%) 
Vascular disorders         
FLUSHING  1  1/75 (1.33%)  0/79 (0.00%)  1/79 (1.27%)  1/17 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
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: Jeff Chodakewitz, M.D.
Organization: Vertex Pharmaceuticals Incorporated
Phone: 617-341-6777
EMail: Jeff_Chodakewitz@vrtx.com
Layout table for additonal information
Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00336479     History of Changes
Other Study ID Numbers: VX05-950-104
First Submitted: June 9, 2006
First Posted: June 13, 2006
Results First Submitted: June 22, 2011
Results First Posted: July 21, 2011
Last Update Posted: July 23, 2014