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A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)

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ClinicalTrials.gov Identifier: NCT00420784
Recruitment Status : Completed
First Posted : January 11, 2007
Results First Posted : July 21, 2011
Last Update Posted : August 5, 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 Hepatitis C
Interventions Drug: Telaprevir
Drug: Ribavirin
Drug: Pegylated Interferon Alfa 2a
Drug: Matching Placebo
Enrollment 465
Recruitment Details  
Pre-assignment Details A total of 465 subjects were enrolled, of which 12 subjects discontinued the study prior to study drug administration. A total of 453 subjects started treatment.
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Hide Arm/Group Description Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet 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 24 weeks. Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 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 1125 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, for 24 weeks. Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 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.
Period Title: Overall Study
Started 115 113 111 114
Completed 86 55 58 36
Not Completed 29 58 53 78
Reason Not Completed
Adverse Event             11             29             10             5
Withdrawal by Subject             0             1             0             0
Lost to Follow-up             0             0             2             1
Virologic Stopping Rule             17             26             41             67
Other             1             2             0             5
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week Total
Hide Arm/Group Description Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet 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 24 weeks. Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 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 1125 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, for 24 weeks. Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 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. Total of all reporting groups
Overall Number of Baseline Participants 115 113 111 114 453
Hide Baseline Analysis Population Description
Full Analysis Set = subjects who received at least 1 dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 113 participants 111 participants 114 participants 453 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
114
  99.1%
111
  98.2%
108
  97.3%
113
  99.1%
446
  98.5%
>=65 years
1
   0.9%
2
   1.8%
3
   2.7%
1
   0.9%
7
   1.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 115 participants 113 participants 111 participants 114 participants 453 participants
49.7  (7.8) 52.0  (5.5) 51.9  (7.1) 49.8  (7.2) 50.8  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 113 participants 111 participants 114 participants 453 participants
Female
37
  32.2%
33
  29.2%
39
  35.1%
38
  33.3%
147
  32.5%
Male
78
  67.8%
80
  70.8%
72
  64.9%
76
  66.7%
306
  67.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 115 participants 113 participants 111 participants 114 participants 453 participants
North America 101 103 101 101 406
Europe 14 10 10 13 47
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
Full Analysis Set = subjects who received at least 1 dose of study drug
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Hide Arm/Group Description:
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet 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 24 weeks.
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 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 1125 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, for 24 weeks.
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 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.
Overall Number of Participants Analyzed 115 113 111 114
Measure Type: Number
Unit of Measure: percentage of participants
51.3 53.1 24.3 14.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, PBO 24 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 <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.23
Confidence Interval (2-Sided) 95%
4.14 to 16.36
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week, PBO 24 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 <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.52
Confidence Interval (2-Sided) 95%
4.72 to 19.20
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week, PBO 24 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 0.024
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.31
Confidence Interval (2-Sided) 95%
1.12 to 4.75
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects With Undetectable Plasma HCV RNA at 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 Completion of study drug dosing (up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set = subjects who received at least 1 dose of study drug.
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Hide Arm/Group Description:
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet 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 24 weeks.
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 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 1125 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, for 24 weeks.
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 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.
Overall Number of Participants Analyzed 115 113 111 114
Measure Type: Number
Unit of Measure: percentage of participants
75.7 67.3 54.1 29.8
3.Secondary Outcome
Title Percentage of Subjects With Undetectable Plasma HCV RNA
Hide Description Percentage of subjects with undetectable HCV RNA at 24 weeks after last dose of study drug for treatment group "PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week" and at 48 weeks after last dose of study drug for treatment groups "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week", "Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week" were presented. 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 Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set = subjects who received at least 1 dose of study drug.
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Hide Arm/Group Description:
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet 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 24 weeks.
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 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 1125 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, for 24 weeks.
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 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.
Overall Number of Participants Analyzed 115 113 111 114
Measure Type: Number
Unit of Measure: percentage of participants
48.7 44.2 22.5 14.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, PBO 24 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 <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.64
Confidence Interval (2-Sided) 95%
3.41 to 12.96
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week, PBO 24 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 <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.72
Confidence Interval (2-Sided) 95%
2.91 to 11.27
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week, PBO 24 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 0.067
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.95
Confidence Interval (2-Sided) 95%
0.95 to 4.00
Estimation Comments [Not Specified]
4.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 2 weeks after last dose of study drug (up to Week 50)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set = subjects who received at least 1 dose of study drug.
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Hide Arm/Group Description:
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet 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 24 weeks.
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 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 1125 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, for 24 weeks.
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 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.
Overall Number of Participants Analyzed 115 113 111 114
Measure Type: Number
Unit of Measure: participants
AEs 112 113 105 111
SAEs 6 16 6 9
5.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 24 week 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 Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Hide Arm/Group Description:
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet 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 24 weeks.
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 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 1125 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, for 24 weeks.
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 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.
Overall Number of Participants Analyzed 87 76 60 34
Measure Type: Number
Unit of Measure: participants
26 10 32 18
6.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 Week 2, 4, 8, 12, 16, 24
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 who received single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week" reporting group and for 24 weeks in "Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week" reporting groups.
Overall Number of Participants Analyzed 339
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Cmax 2755  (811)
Cmin 2335  (733)
Cavg 2610  (780)
Time Frame Baseline up to 2 weeks after last dose of study drug (up to Week 50)
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 Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Hide Arm/Group Description Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet 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 24 weeks. Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 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 1125 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, for 24 weeks. Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 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.
All-Cause Mortality
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/115 (5.22%)   16/113 (14.16%)   6/111 (5.41%)   9/114 (7.89%) 
Blood and lymphatic system disorders         
Anaemia  1  0/115 (0.00%)  6/113 (5.31%)  0/111 (0.00%)  1/114 (0.88%) 
Haemorrhagic anaemia  1  0/115 (0.00%)  0/113 (0.00%)  1/111 (0.90%)  0/114 (0.00%) 
Idiopathic thrombocytopenic purpura  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Cardiac disorders         
Cardiomyopathy  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Eye disorders         
Retinal detachment  1  0/115 (0.00%)  0/113 (0.00%)  1/111 (0.90%)  0/114 (0.00%) 
Gastrointestinal disorders         
Pancreatitis  1  1/115 (0.87%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Small intestinal obstruction  1  0/115 (0.00%)  1/113 (0.88%)  1/111 (0.90%)  0/114 (0.00%) 
Diverticular perforation  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Gastritis erosive  1  0/115 (0.00%)  0/113 (0.00%)  1/111 (0.90%)  0/114 (0.00%) 
Pancreatitis acute  1  1/115 (0.87%)  0/113 (0.00%)  0/111 (0.00%)  0/114 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/115 (0.00%)  0/113 (0.00%)  1/111 (0.90%)  0/114 (0.00%) 
Hepatobiliary disorders         
Cholelithiasis  1  0/115 (0.00%)  2/113 (1.77%)  0/111 (0.00%)  0/114 (0.00%) 
Cholecystitis acute  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Infections and infestations         
Gastroenteritis  1  0/115 (0.00%)  6/113 (5.31%)  3/111 (2.70%)  2/114 (1.75%) 
Pneumonia  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  1/114 (0.88%) 
Abscess intestinal  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Cholecystitis infective  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Diverticulitis  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Gastroenteritis viral  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Infected insect bite  1  0/115 (0.00%)  0/113 (0.00%)  1/111 (0.90%)  0/114 (0.00%) 
Necrotising fasciitis  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Pneumonia pneumococcal  1  0/115 (0.00%)  0/113 (0.00%)  1/111 (0.90%)  0/114 (0.00%) 
Postoperative wound infection  1  0/115 (0.00%)  0/113 (0.00%)  1/111 (0.90%)  0/114 (0.00%) 
Sepsis syndrome  1  0/115 (0.00%)  0/113 (0.00%)  1/111 (0.90%)  0/114 (0.00%) 
Sinusitis  1  0/115 (0.00%)  0/113 (0.00%)  0/111 (0.00%)  1/114 (0.88%) 
Injury, poisoning and procedural complications         
Post procedural bile leak  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  2/114 (1.75%) 
Hypokalaemia  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Hypovolaemia  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/115 (0.00%)  0/113 (0.00%)  0/111 (0.00%)  1/114 (0.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
B-cell unclassifiable lymphoma low grade  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Non-small cell lung cancer  1  0/115 (0.00%)  0/113 (0.00%)  0/111 (0.00%)  1/114 (0.88%) 
Nervous system disorders         
Headache  1  0/115 (0.00%)  0/113 (0.00%)  0/111 (0.00%)  1/114 (0.88%) 
Migraine with aura  1  0/115 (0.00%)  0/113 (0.00%)  1/111 (0.90%)  0/114 (0.00%) 
Ruptured cerebral aneurysm  1  1/115 (0.87%)  0/113 (0.00%)  0/111 (0.00%)  0/114 (0.00%) 
Syncope  1  0/115 (0.00%)  0/113 (0.00%)  0/111 (0.00%)  1/114 (0.88%) 
Psychiatric disorders         
Alcohol abuse  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Confusional state  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Depression  1  0/115 (0.00%)  0/113 (0.00%)  0/111 (0.00%)  1/114 (0.88%) 
Suicidal ideation  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Renal and urinary disorders         
Renal failure acute  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  1/114 (0.88%) 
Neurogenic bladder  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Renal tubular acidosis  1  0/115 (0.00%)  0/113 (0.00%)  0/111 (0.00%)  1/114 (0.88%) 
Skin and subcutaneous tissue disorders         
Rash  1  2/115 (1.74%)  0/113 (0.00%)  1/111 (0.90%)  0/114 (0.00%) 
Decubitus ulcer  1  0/115 (0.00%)  0/113 (0.00%)  0/111 (0.00%)  1/114 (0.88%) 
Dermatitis  1  1/115 (0.87%)  0/113 (0.00%)  0/111 (0.00%)  0/114 (0.00%) 
Eczema  1  0/115 (0.00%)  0/113 (0.00%)  1/111 (0.90%)  0/114 (0.00%) 
Lichenoid keratosis  1  0/115 (0.00%)  0/113 (0.00%)  1/111 (0.90%)  0/114 (0.00%) 
Rash macular  1  0/115 (0.00%)  0/113 (0.00%)  1/111 (0.90%)  0/114 (0.00%) 
Vascular disorders         
Haematoma  1  0/115 (0.00%)  0/113 (0.00%)  0/111 (0.00%)  1/114 (0.88%) 
Hypotension  1  0/115 (0.00%)  1/113 (0.88%)  0/111 (0.00%)  0/114 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   112/115 (97.39%)   112/113 (99.12%)   105/111 (94.59%)   111/114 (97.37%) 
Blood and lymphatic system disorders         
Anaemia  1  30/115 (26.09%)  30/113 (26.55%)  9/111 (8.11%)  9/114 (7.89%) 
Neutropenia  1  12/115 (10.43%)  11/113 (9.73%)  8/111 (7.21%)  7/114 (6.14%) 
Thrombocytopenia  1  3/115 (2.61%)  5/113 (4.42%)  10/111 (9.01%)  0/114 (0.00%) 
Eye disorders         
Vision blurred  1  6/115 (5.22%)  10/113 (8.85%)  7/111 (6.31%)  6/114 (5.26%) 
Gastrointestinal disorders         
Nausea  1  41/115 (35.65%)  54/113 (47.79%)  27/111 (24.32%)  39/114 (34.21%) 
Diarrhoea  1  37/115 (32.17%)  49/113 (43.36%)  29/111 (26.13%)  22/114 (19.30%) 
Haemorrhoids  1  15/115 (13.04%)  19/113 (16.81%)  14/111 (12.61%)  3/114 (2.63%) 
Vomiting  1  15/115 (13.04%)  13/113 (11.50%)  9/111 (8.11%)  13/114 (11.40%) 
Dry mouth  1  8/115 (6.96%)  13/113 (11.50%)  9/111 (8.11%)  6/114 (5.26%) 
Abdominal pain  1  6/115 (5.22%)  6/113 (5.31%)  7/111 (6.31%)  8/114 (7.02%) 
Constipation  1  4/115 (3.48%)  6/113 (5.31%)  2/111 (1.80%)  9/114 (7.89%) 
Anorectal discomfort  1  8/115 (6.96%)  7/113 (6.19%)  4/111 (3.60%)  0/114 (0.00%) 
Gastrooesophageal reflux disease  1  4/115 (3.48%)  7/113 (6.19%)  2/111 (1.80%)  6/114 (5.26%) 
Flatulence  1  6/115 (5.22%)  7/113 (6.19%)  2/111 (1.80%)  3/114 (2.63%) 
Proctalgia  1  6/115 (5.22%)  1/113 (0.88%)  4/111 (3.60%)  0/114 (0.00%) 
Stomach discomfort  1  7/115 (6.09%)  2/113 (1.77%)  2/111 (1.80%)  0/114 (0.00%) 
General disorders         
Fatigue  1  77/115 (66.96%)  69/113 (61.06%)  51/111 (45.95%)  64/114 (56.14%) 
Influenza like illness  1  29/115 (25.22%)  36/113 (31.86%)  28/111 (25.23%)  36/114 (31.58%) 
Irritability  1  20/115 (17.39%)  27/113 (23.89%)  16/111 (14.41%)  25/114 (21.93%) 
Pyrexia  1  16/115 (13.91%)  27/113 (23.89%)  16/111 (14.41%)  14/114 (12.28%) 
Chills  1  17/115 (14.78%)  23/113 (20.35%)  17/111 (15.32%)  15/114 (13.16%) 
Injection site erythema  1  14/115 (12.17%)  10/113 (8.85%)  9/111 (8.11%)  5/114 (4.39%) 
Pain  1  8/115 (6.96%)  4/113 (3.54%)  6/111 (5.41%)  4/114 (3.51%) 
Oedema peripheral  1  3/115 (2.61%)  6/113 (5.31%)  5/111 (4.50%)  1/114 (0.88%) 
Infections and infestations         
Upper respiratory tract infection  1  1/115 (0.87%)  8/113 (7.08%)  4/111 (3.60%)  3/114 (2.63%) 
Urinary tract infection  1  5/115 (4.35%)  7/113 (6.19%)  4/111 (3.60%)  0/114 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  7/115 (6.09%)  8/113 (7.08%)  5/111 (4.50%)  12/114 (10.53%) 
Musculoskeletal and connective tissue disorders         
Myalgia  1  25/115 (21.74%)  16/113 (14.16%)  19/111 (17.12%)  21/114 (18.42%) 
Arthralgia  1  14/115 (12.17%)  22/113 (19.47%)  15/111 (13.51%)  21/114 (18.42%) 
Back pain  1  8/115 (6.96%)  6/113 (5.31%)  5/111 (4.50%)  9/114 (7.89%) 
Muscle spasms  1  6/115 (5.22%)  3/113 (2.65%)  5/111 (4.50%)  6/114 (5.26%) 
Nervous system disorders         
Headache  1  51/115 (44.35%)  39/113 (34.51%)  40/111 (36.04%)  41/114 (35.96%) 
Dizziness  1  10/115 (8.70%)  20/113 (17.70%)  17/111 (15.32%)  18/114 (15.79%) 
Dysgeusia  1  5/115 (4.35%)  10/113 (8.85%)  8/111 (7.21%)  8/114 (7.02%) 
Disturbance in attention  1  7/115 (6.09%)  7/113 (6.19%)  8/111 (7.21%)  7/114 (6.14%) 
Memory impairment  1  2/115 (1.74%)  8/113 (7.08%)  1/111 (0.90%)  2/114 (1.75%) 
Psychiatric disorders         
Insomnia  1  33/115 (28.70%)  30/113 (26.55%)  20/111 (18.02%)  19/114 (16.67%) 
Anxiety  1  10/115 (8.70%)  13/113 (11.50%)  4/111 (3.60%)  10/114 (8.77%) 
Depression  1  13/115 (11.30%)  17/113 (15.04%)  13/111 (11.71%)  19/114 (16.67%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  11/115 (9.57%)  10/113 (8.85%)  6/111 (5.41%)  9/114 (7.89%) 
Pharyngolaryngeal pain  1  5/115 (4.35%)  11/113 (9.73%)  2/111 (1.80%)  9/114 (7.89%) 
Dyspnoea exertional  1  7/115 (6.09%)  9/113 (7.96%)  3/111 (2.70%)  5/114 (4.39%) 
Nasal congestion  1  0/115 (0.00%)  7/113 (6.19%)  1/111 (0.90%)  2/114 (1.75%) 
Cough  1  15/115 (13.04%)  22/113 (19.47%)  9/111 (8.11%)  20/114 (17.54%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  39/115 (33.91%)  50/113 (44.25%)  40/111 (36.04%)  17/114 (14.91%) 
Rash  1  43/115 (37.39%)  51/113 (45.13%)  32/111 (28.83%)  20/114 (17.54%) 
Alopecia  1  24/115 (20.87%)  16/113 (14.16%)  14/111 (12.61%)  13/114 (11.40%) 
Dry skin  1  12/115 (10.43%)  8/113 (7.08%)  12/111 (10.81%)  7/114 (6.14%) 
Pruritus generalised  1  5/115 (4.35%)  10/113 (8.85%)  6/111 (5.41%)  4/114 (3.51%) 
Rash macular  1  6/115 (5.22%)  4/113 (3.54%)  7/111 (6.31%)  2/114 (1.75%) 
Rash generalised  1  2/115 (1.74%)  7/113 (6.19%)  4/111 (3.60%)  0/114 (0.00%) 
Rash pruritic  1  4/115 (3.48%)  6/113 (5.31%)  2/111 (1.80%)  1/114 (0.88%) 
Rash papular  1  6/115 (5.22%)  2/113 (1.77%)  3/111 (2.70%)  0/114 (0.00%) 
Vascular disorders         
Hypertension  1  1/115 (0.87%)  6/113 (5.31%)  0/111 (0.00%)  1/114 (0.88%) 
Indicates events were collected by systematic assessment
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: 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: NCT00420784     History of Changes
Other Study ID Numbers: VX06-950-106
First Submitted: January 8, 2007
First Posted: January 11, 2007
Results First Submitted: June 22, 2011
Results First Posted: July 21, 2011
Last Update Posted: August 5, 2014