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Trial record 73 of 535 for:    IFNA2 AND RBV AND HCV

Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C

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ClinicalTrials.gov Identifier: NCT00372385
Recruitment Status : Completed
First Posted : September 6, 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: Ribavirin
Drug: Pegylated Interferon Alfa 2a
Drug: Placebo
Drug: Telaprevir
Enrollment 334
Recruitment Details  
Pre-assignment Details A total of 334 subjects were enrolled, of which 11 subjects discontinued the study prior to study drug administration. A total of 323 subjects started treatment.
Arm/Group Title PBO 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 Telaprevir 12 Week+Peg-IFN-alfa-2a 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) 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 orally 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. 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, for 12 weeks.
Period Title: Overall Study
Started 82 81 82 78
Completed 49 61 72 70
Not Completed 33 20 10 8
Reason Not Completed
Adverse Event             6             11             9             7
Noncompliance             0             1             1             1
Physician Decision             1             0             0             0
Lost to Follow-up             2             0             0             0
Withdrawal by Subject             2             1             0             0
Refusal of Treatment             3             6             0             0
No Response             1             1             0             0
Ineligibility due to Exclusion Criterion             1             0             0             0
Virologic Stopping Rule             17             0             0             0
Arm/Group Title PBO 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 Telaprevir 12 Week+Peg-IFN-alfa-2a 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) 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 orally 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. 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, for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 82 81 82 78 323
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 82 participants 81 participants 82 participants 78 participants 323 participants
<=18 years
1
   1.2%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
Between 18 and 65 years
81
  98.8%
80
  98.8%
81
  98.8%
78
 100.0%
320
  99.1%
>=65 years
0
   0.0%
1
   1.2%
1
   1.2%
0
   0.0%
2
   0.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 81 participants 82 participants 78 participants 323 participants
44.4  (10.6) 44.3  (10.0) 44.1  (10.2) 44.3  (10.8) 44.3  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 81 participants 82 participants 78 participants 323 participants
Female
36
  43.9%
27
  33.3%
33
  40.2%
35
  44.9%
131
  40.6%
Male
46
  56.1%
54
  66.7%
49
  59.8%
43
  55.1%
192
  59.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Europe Number Analyzed 82 participants 81 participants 82 participants 78 participants 323 participants
82 81 82 78 323
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 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Telaprevir 12 Week+Peg-IFN-alfa-2a 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) 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 orally 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.
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, for 12 weeks.
Overall Number of Participants Analyzed 82 81 82 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
46.3
(35 to 58)
69.1
(58 to 79)
59.8
(48 to 70)
35.9
(25 to 48)
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 24 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0026
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.758
Confidence Interval (2-Sided) 95%
1.424 to 5.340
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 12 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.959
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.709
Confidence Interval (2-Sided) 95%
0.910 to 3.212
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1089
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.589
Confidence Interval (2-Sided) 95%
0.309 to 1.125
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 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Telaprevir 12 Week+Peg-IFN-alfa-2a 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) 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 orally 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.
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, for 12 weeks.
Overall Number of Participants Analyzed 82 81 82 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
47.6
(36 to 59)
69.1
(58 to 79)
59.8
(48 to 70)
37.2
(26 to 49)
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 24 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0041
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.632
Confidence Interval (2-Sided) 95%
1.359 to 5.097
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 12 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1324
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.623
Confidence Interval (2-Sided) 95%
0.864 to 3.050
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1099
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.591
Confidence Interval (2-Sided) 95%
0.311 to 1.126
Estimation Comments [Not Specified]
3.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
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 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Telaprevir 12 Week+Peg-IFN-alfa-2a 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) 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 orally 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.
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, for 12 weeks.
Overall Number of Participants Analyzed 82 81 82 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.9
(43 to 66)
70.4
(59 to 80)
80.5
(70 to 88)
61.5
(50 to 72)
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 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 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Telaprevir 12 Week+Peg-IFN-alfa-2a 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) 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 orally 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.
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, for 12 weeks.
Overall Number of Participants Analyzed 82 81 82 78
Measure Type: Number
Unit of Measure: participants
AEs 81 80 82 78
SAEs 8 16 11 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 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 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Telaprevir 12 Week+Peg-IFN-alfa-2a 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) 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 orally 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.
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, for 12 weeks.
Overall Number of Participants Analyzed 45 57 63 46
Measure Type: Number
Unit of Measure: participants
10 8 19 22
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 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 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week” and “Telaprevir 12 Week+Peg-IFN-alfa-2a 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 239
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Cmax 3370  (755)
Cmin 2510  (604)
Cavg 3055  (694)
Time Frame Adverse Events during Baseline through 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 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Telaprevir 12 Week+Peg-IFN-alfa-2a 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) 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 orally 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. 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, for 12 weeks.
All-Cause Mortality
PBO 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 Telaprevir 12 Week+Peg-IFN-alfa-2a 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 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/82 (9.76%)   16/81 (19.75%)   11/82 (13.41%)   9/78 (11.54%) 
Blood and lymphatic system disorders         
ANAEMIA  1  2/82 (2.44%)  3/81 (3.70%)  1/82 (1.22%)  1/78 (1.28%) 
HAEMORRHAGIC ANAEMIA  1  1/82 (1.22%)  0/81 (0.00%)  0/82 (0.00%)  0/78 (0.00%) 
LYMPHADENOPATHY  1  0/82 (0.00%)  0/81 (0.00%)  0/82 (0.00%)  1/78 (1.28%) 
PANCYTOPENIA  1  0/82 (0.00%)  0/81 (0.00%)  0/82 (0.00%)  1/78 (1.28%) 
Cardiac disorders         
ANGINA PECTORIS  1  1/82 (1.22%)  0/81 (0.00%)  0/82 (0.00%)  0/78 (0.00%) 
Congenital, familial and genetic disorders         
HYDROCELE  1  0/82 (0.00%)  1/81 (1.23%)  0/82 (0.00%)  0/78 (0.00%) 
Endocrine disorders         
HYPERTHYROIDISM  1  1/82 (1.22%)  0/81 (0.00%)  0/82 (0.00%)  0/78 (0.00%) 
Eye disorders         
RETINAL HAEMORRHAGE  1  0/82 (0.00%)  0/81 (0.00%)  0/82 (0.00%)  1/78 (1.28%) 
Gastrointestinal disorders         
ABDOMINAL PAIN  1  0/82 (0.00%)  1/81 (1.23%)  0/82 (0.00%)  1/78 (1.28%) 
ALCOHOLIC PANCREATITIS  1  1/82 (1.22%)  0/81 (0.00%)  0/82 (0.00%)  0/78 (0.00%) 
NAUSEA  1  0/82 (0.00%)  1/81 (1.23%)  0/82 (0.00%)  0/78 (0.00%) 
PANCREATITIS ACUTE  1  0/82 (0.00%)  1/81 (1.23%)  0/82 (0.00%)  0/78 (0.00%) 
General disorders         
ASTHENIA  1  0/82 (0.00%)  1/81 (1.23%)  0/82 (0.00%)  0/78 (0.00%) 
CATHETER RELATED COMPLICATION  1  0/82 (0.00%)  0/81 (0.00%)  1/82 (1.22%)  0/78 (0.00%) 
CHILLS  1  0/82 (0.00%)  0/81 (0.00%)  0/82 (0.00%)  1/78 (1.28%) 
PYREXIA  1  0/82 (0.00%)  0/81 (0.00%)  0/82 (0.00%)  1/78 (1.28%) 
Infections and infestations         
BACTERIAL SEPSIS  1  0/82 (0.00%)  0/81 (0.00%)  1/82 (1.22%)  0/78 (0.00%) 
GASTROENTERITIS  1  1/82 (1.22%)  0/81 (0.00%)  0/82 (0.00%)  0/78 (0.00%) 
PNEUMONIA HERPES VIRAL  1  0/82 (0.00%)  1/81 (1.23%)  0/82 (0.00%)  0/78 (0.00%) 
SEPSIS  1  0/82 (0.00%)  1/81 (1.23%)  0/82 (0.00%)  0/78 (0.00%) 
Injury, poisoning and procedural complications         
ROAD TRAFFIC ACCIDENT  1  0/82 (0.00%)  0/81 (0.00%)  0/82 (0.00%)  1/78 (1.28%) 
TENDON RUPTURE  1  0/82 (0.00%)  1/81 (1.23%)  0/82 (0.00%)  0/78 (0.00%) 
Musculoskeletal and connective tissue disorders         
BACK PAIN  1  0/82 (0.00%)  0/81 (0.00%)  0/82 (0.00%)  1/78 (1.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
LUNG NEOPLASM MALIGNANT  1  0/82 (0.00%)  1/81 (1.23%)  0/82 (0.00%)  0/78 (0.00%) 
Nervous system disorders         
SYNCOPE  1  1/82 (1.22%)  1/81 (1.23%)  1/82 (1.22%)  1/78 (1.28%) 
SPEECH DISORDER  1  0/82 (0.00%)  0/81 (0.00%)  0/82 (0.00%)  1/78 (1.28%) 
Psychiatric disorders         
DEPRESSION  1  0/82 (0.00%)  0/81 (0.00%)  1/82 (1.22%)  2/78 (2.56%) 
DISORIENTATION  1  0/82 (0.00%)  0/81 (0.00%)  0/82 (0.00%)  1/78 (1.28%) 
EMOTIONAL DISTRESS  1  0/82 (0.00%)  0/81 (0.00%)  1/82 (1.22%)  0/78 (0.00%) 
PARANOIA  1  1/82 (1.22%)  0/81 (0.00%)  0/82 (0.00%)  0/78 (0.00%) 
SUICIDE ATTEMPT  1  0/82 (0.00%)  0/81 (0.00%)  1/82 (1.22%)  0/78 (0.00%) 
Renal and urinary disorders         
RENAL FAILURE ACUTE  1  0/82 (0.00%)  0/81 (0.00%)  0/82 (0.00%)  1/78 (1.28%) 
Reproductive system and breast disorders         
TESTICULAR SWELLING  1  0/82 (0.00%)  1/81 (1.23%)  0/82 (0.00%)  0/78 (0.00%) 
UTERINE POLYP  1  1/82 (1.22%)  0/81 (0.00%)  0/82 (0.00%)  0/78 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
DYSPNOEA  1  0/82 (0.00%)  2/81 (2.47%)  0/82 (0.00%)  0/78 (0.00%) 
Skin and subcutaneous tissue disorders         
RASH  1  0/82 (0.00%)  4/81 (4.94%)  1/82 (1.22%)  0/78 (0.00%) 
PRURITUS  1  0/82 (0.00%)  2/81 (2.47%)  0/82 (0.00%)  1/78 (1.28%) 
DRUG ERUPTION  1  0/82 (0.00%)  0/81 (0.00%)  1/82 (1.22%)  1/78 (1.28%) 
RASH MACULO-PAPULAR  1  0/82 (0.00%)  2/81 (2.47%)  0/82 (0.00%)  0/78 (0.00%) 
RASH ERYTHEMATOUS  1  0/82 (0.00%)  0/81 (0.00%)  1/82 (1.22%)  0/78 (0.00%) 
RASH GENERALISED  1  0/82 (0.00%)  0/81 (0.00%)  0/82 (0.00%)  1/78 (1.28%) 
TOXIC SKIN ERUPTION  1  0/82 (0.00%)  0/81 (0.00%)  1/82 (1.22%)  0/78 (0.00%) 
URTICARIA  1  0/82 (0.00%)  0/81 (0.00%)  1/82 (1.22%)  0/78 (0.00%) 
Surgical and medical procedures         
SPLENECTOMY  1  0/82 (0.00%)  0/81 (0.00%)  0/82 (0.00%)  1/78 (1.28%) 
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 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   81/82 (98.78%)   80/81 (98.77%)   82/82 (100.00%)   78/78 (100.00%) 
Blood and lymphatic system disorders         
ANAEMIA  1  14/82 (17.07%)  22/81 (27.16%)  15/82 (18.29%)  7/78 (8.97%) 
NEUTROPENIA  1  14/82 (17.07%)  3/81 (3.70%)  6/82 (7.32%)  2/78 (2.56%) 
LYMPHADENOPATHY  1  1/82 (1.22%)  0/81 (0.00%)  3/82 (3.66%)  5/78 (6.41%) 
Ear and labyrinth disorders         
VERTIGO  1  11/82 (13.41%)  6/81 (7.41%)  7/82 (8.54%)  4/78 (5.13%) 
Eye disorders         
DRY EYE  1  4/82 (4.88%)  5/81 (6.17%)  5/82 (6.10%)  2/78 (2.56%) 
Gastrointestinal disorders         
NAUSEA  1  33/82 (40.24%)  39/81 (48.15%)  39/82 (47.56%)  24/78 (30.77%) 
DIARRHOEA  1  23/82 (28.05%)  20/81 (24.69%)  26/82 (31.71%)  20/78 (25.64%) 
ABDOMINAL PAIN UPPER  1  13/82 (15.85%)  8/81 (9.88%)  8/82 (9.76%)  7/78 (8.97%) 
VOMITING  1  12/82 (14.63%)  10/81 (12.35%)  5/82 (6.10%)  7/78 (8.97%) 
ABDOMINAL PAIN  1  10/82 (12.20%)  8/81 (9.88%)  6/82 (7.32%)  5/78 (6.41%) 
HAEMORRHOIDS  1  2/82 (2.44%)  9/81 (11.11%)  10/82 (12.20%)  5/78 (6.41%) 
DRY MOUTH  1  4/82 (4.88%)  1/81 (1.23%)  9/82 (10.98%)  6/78 (7.69%) 
ANAL PRURITUS  1  0/82 (0.00%)  6/81 (7.41%)  9/82 (10.98%)  4/78 (5.13%) 
ANORECTAL DISCOMFORT  1  2/82 (2.44%)  4/81 (4.94%)  9/82 (10.98%)  3/78 (3.85%) 
RECTAL HAEMORRHAGE  1  0/82 (0.00%)  0/81 (0.00%)  5/82 (6.10%)  2/78 (2.56%) 
General disorders         
ASTHENIA  1  26/82 (31.71%)  37/81 (45.68%)  43/82 (52.44%)  30/78 (38.46%) 
INFLUENZA LIKE ILLNESS  1  43/82 (52.44%)  32/81 (39.51%)  32/82 (39.02%)  28/78 (35.90%) 
Fatigue  1  30/82 (36.59%)  21/81 (25.93%)  23/82 (28.05%)  26/78 (33.33%) 
PYREXIA  1  19/82 (23.17%)  14/81 (17.28%)  15/82 (18.29%)  15/78 (19.23%) 
IRRITABILITY  1  11/82 (13.41%)  7/81 (8.64%)  7/82 (8.54%)  8/78 (10.26%) 
CHILLS  1  10/82 (12.20%)  1/81 (1.23%)  6/82 (7.32%)  5/78 (6.41%) 
INJECTION SITE ERYTHEMA  1  3/82 (3.66%)  2/81 (2.47%)  4/82 (4.88%)  6/78 (7.69%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/82 (0.00%)  2/81 (2.47%)  3/82 (3.66%)  4/78 (5.13%) 
Infections and infestations         
INFLUENZA  1  6/82 (7.32%)  9/81 (11.11%)  2/82 (2.44%)  8/78 (10.26%) 
NASOPHARYNGITIS  1  8/82 (9.76%)  5/81 (6.17%)  5/82 (6.10%)  4/78 (5.13%) 
BRONCHITIS  1  1/82 (1.22%)  1/81 (1.23%)  1/82 (1.22%)  4/78 (5.13%) 
Investigations         
WEIGHT DECREASED  1  6/82 (7.32%)  5/81 (6.17%)  2/82 (2.44%)  4/78 (5.13%) 
Metabolism and nutrition disorders         
DECREASED APPETITE  1  16/82 (19.51%)  5/81 (6.17%)  9/82 (10.98%)  16/78 (20.51%) 
ANOREXIA  1  2/82 (2.44%)  4/81 (4.94%)  5/82 (6.10%)  1/78 (1.28%) 
Musculoskeletal and connective tissue disorders         
MYALGIA  1  17/82 (20.73%)  11/81 (13.58%)  12/82 (14.63%)  12/78 (15.38%) 
ARTHRALGIA  1  14/82 (17.07%)  8/81 (9.88%)  8/82 (9.76%)  20/78 (25.64%) 
BACK PAIN  1  16/82 (19.51%)  4/81 (4.94%)  4/82 (4.88%)  10/78 (12.82%) 
Nervous system disorders         
HEADACHE  1  37/82 (45.12%)  36/81 (44.44%)  32/82 (39.02%)  37/78 (47.44%) 
DYSGEUSIA  1  3/82 (3.66%)  5/81 (6.17%)  11/82 (13.41%)  4/78 (5.13%) 
DIZZINESS  1  8/82 (9.76%)  5/81 (6.17%)  6/82 (7.32%)  1/78 (1.28%) 
DISTURBANCE IN ATTENTION  1  2/82 (2.44%)  5/81 (6.17%)  4/82 (4.88%)  7/78 (8.97%) 
LETHARGY  1  4/82 (4.88%)  1/81 (1.23%)  2/82 (2.44%)  4/78 (5.13%) 
Psychiatric disorders         
INSOMNIA  1  32/82 (39.02%)  23/81 (28.40%)  28/82 (34.15%)  11/78 (14.10%) 
DEPRESSION  1  19/82 (23.17%)  16/81 (19.75%)  18/82 (21.95%)  17/78 (21.79%) 
ANXIETY  1  3/82 (3.66%)  4/81 (4.94%)  5/82 (6.10%)  5/78 (6.41%) 
NERVOUSNESS  1  4/82 (4.88%)  1/81 (1.23%)  6/82 (7.32%)  5/78 (6.41%) 
Respiratory, thoracic and mediastinal disorders         
DYSPNOEA  1  13/82 (15.85%)  18/81 (22.22%)  21/82 (25.61%)  11/78 (14.10%) 
COUGH  1  21/82 (25.61%)  15/81 (18.52%)  14/82 (17.07%)  8/78 (10.26%) 
PHARYNGOLARYNGEAL PAIN  1  10/82 (12.20%)  11/81 (13.58%)  7/82 (8.54%)  3/78 (3.85%) 
DYSPNOEA EXERTIONAL  1  4/82 (4.88%)  0/81 (0.00%)  4/82 (4.88%)  4/78 (5.13%) 
Skin and subcutaneous tissue disorders         
PRURITUS  1  29/82 (35.37%)  41/81 (50.62%)  52/82 (63.41%)  46/78 (58.97%) 
DRY SKIN  1  29/82 (35.37%)  21/81 (25.93%)  21/82 (25.61%)  22/78 (28.21%) 
RASH  1  22/82 (26.83%)  27/81 (33.33%)  23/82 (28.05%)  21/78 (26.92%) 
ALOPECIA  1  17/82 (20.73%)  15/81 (18.52%)  3/82 (3.66%)  11/78 (14.10%) 
ECZEMA  1  5/82 (6.10%)  10/81 (12.35%)  13/82 (15.85%)  4/78 (5.13%) 
ERYTHEMA  1  2/82 (2.44%)  7/81 (8.64%)  5/82 (6.10%)  7/78 (8.97%) 
RASH PRURITIC  1  4/82 (4.88%)  5/81 (6.17%)  4/82 (4.88%)  6/78 (7.69%) 
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: NCT00372385     History of Changes
Other Study ID Numbers: VX05-950-104EU
First Submitted: September 1, 2006
First Posted: September 6, 2006
Results First Submitted: June 22, 2011
Results First Posted: July 21, 2011
Last Update Posted: July 23, 2014