Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00535847
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : July 25, 2011
Last Update Posted : August 5, 2014
Sponsor:
Collaborator:
Tibotec, Inc
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Telaprevir
Drug: Ribavirin
Drug: Pegylated interferon alfa 2a
Enrollment 117
Recruitment Details Subjects randomized to placebo control group in parent studies VX05-950-104 (NCT00336479), VX05-950-104EU (NCT00372385) and VX06-950-106 (NCT00420784) who had discontinued treatment in the parent study due to an inadequate response to treatment or relapsed after treatment were eligible to participate in this study VX06-950-107 (NCT00535847).
Pre-assignment Details  
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Other
Hide Arm/Group Description Telaprevir 750 mg 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. Telaprevir 750 mg 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. Subjects received telaprevir 750 mg 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 <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.
Period Title: Overall Study
Started 81 34 2
Completed 59 20 0
Not Completed 22 14 2
Reason Not Completed
Adverse Event             5             3             2
Non compliance             1             1             0
Protocol-defined Virologic Stopping Rule             16             10             0
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Other Total
Hide Arm/Group Description Telaprevir 750 mg 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. Telaprevir 750 mg 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. Subjects received telaprevir 750 mg 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 <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group. Total of all reporting groups
Overall Number of Baseline Participants 81 34 2 117
Hide Baseline Analysis Population Description
The full analysis (FA) set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 34 participants 2 participants 117 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
81
 100.0%
34
 100.0%
2
 100.0%
117
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 34 participants 2 participants 117 participants
50.0  (7.7) 51.2  (5.9) 49.0  (0.0) 50.3  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 34 participants 2 participants 117 participants
Female
28
  34.6%
8
  23.5%
0
   0.0%
36
  30.8%
Male
53
  65.4%
26
  76.5%
2
 100.0%
81
  69.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 81 participants 34 participants 2 participants 117 participants
North America 64 26 2 92
Europe 17 8 0 25
1.Primary Outcome
Title Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment
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 treatment (up to Week 72)
Hide Outcome Measure Data
Hide Analysis Population Description
The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Other
Hide Arm/Group Description:
Telaprevir 750 mg 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.
Telaprevir 750 mg 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.
Subjects received telaprevir 750 mg 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 <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.
Overall Number of Participants Analyzed 81 34 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60.5
(49.0 to 71.2)
52.9
(35.1 to 70.2)
100.0
(15.8 to 100.0)
2.Primary 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 through Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Other
Hide Arm/Group Description:
Telaprevir 750 mg 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.
Telaprevir 750 mg 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.
Subjects received telaprevir 750 mg 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 <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.
Overall Number of Participants Analyzed 81 34 2
Measure Type: Number
Unit of Measure: participants
AEs 77 31 2
SAEs 7 3 1
3.Secondary Outcome
Title Percentage of Prior Relapsers With Undetectable HCV RNA
Hide Description Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study 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 24 weeks after the completion of treatment (up to Week 72)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all enrolled subjects who were prior relapsers in parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) and received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Other
Hide Arm/Group Description:
Telaprevir 750 mg 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.
Telaprevir 750 mg 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.
Subjects received telaprevir 750 mg 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 <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.
Overall Number of Participants Analyzed 25 3 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.0
(79.6 to 99.9)
100.0
(29.2 to 100.0)
100.0
(2.5 to 100.0)
4.Secondary Outcome
Title Percentage of Subjects With End of Treatment Response
Hide Description Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. 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 End of treatment (up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Other
Hide Arm/Group Description:
Telaprevir 750 mg 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.
Telaprevir 750 mg 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.
Subjects received telaprevir 750 mg 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 <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.
Overall Number of Participants Analyzed 81 34 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
72.8
(61.8 to 82.1)
64.7
(46.5 to 80.3)
100.0
(15.8 to 100.0)
5.Secondary Outcome
Title Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment
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 48 weeks after completion of treatment (up to Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included subjects who completed assigned treatment in this study (VX06-950-107 [NCT00535847]).
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Other
Hide Arm/Group Description:
Telaprevir 750 mg 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.
Telaprevir 750 mg 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.
Subjects received telaprevir 750 mg 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 <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.
Overall Number of Participants Analyzed 59 20 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
83.1
(71.0 to 91.6)
70.0
(45.7 to 88.1)
6.Secondary Outcome
Title Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response
Hide Description Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than [<] 1-log10 decrease in HCV RNA at Week 4 or <2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than [>] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.
Time Frame Baseline up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The FA set included subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]). Data was presented for overall subjects based on eRVR and SVR status as per planned analysis.
Arm/Group Title Achieved eRVR/Achieved SVR Achieved eRVR/Did Not Achieve SVR Did Not Achieve eRVR/Achieved SVR Did Not Achieve eRVR/Did Not Achieve SVR
Hide Arm/Group Description:
All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who achieved eRVR and SVR in this study (VX06-950-107 [NCT00535847]).
All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who achieved eRVR but did not achieve SVR in this study (VX06-950-107 [NCT00535847]).
All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who did not achieve eRVR but achieved SVR in this study (VX06-950-107 [NCT00535847]).
All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who neither achieved eRVR nor SVR in this study (VX06-950-107 [NCT00535847]).
Overall Number of Participants Analyzed 57 12 12 36
Measure Type: Number
Unit of Measure: participants
Prior Null Response 12 5 7 27
Prior Partial Response 15 7 1 6
Prior Viral Breakthrough 6 0 0 2
Prior Relapse 24 0 4 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Achieved eRVR/Achieved SVR, Achieved eRVR/Did Not Achieve SVR, Did Not Achieve eRVR/Achieved SVR, Did Not Achieve eRVR/Did Not Achieve SVR
Comments Stratified Analysis (Mantel-Haenszel)- The Mantel-Haenszel estimator provides an estimate of the common odds ratio for the association between eRVR and SVR across the prior response strata.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 12.703
Confidence Interval (2-Sided) 95%
4.259 to 37.884
Estimation Comments [Not Specified]
Time Frame Adverse Events during Overall Treatment Phase (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 Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Other
Hide Arm/Group Description Telaprevir 750 mg 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. Telaprevir 750 mg 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. Subjects received telaprevir 750 mg 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 <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.
All-Cause Mortality
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Other
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 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Other
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/81 (8.64%)   3/34 (8.82%)   1/2 (50.00%) 
Blood and lymphatic system disorders       
Anaemia  1  3/81 (3.70%)  0/34 (0.00%)  0/2 (0.00%) 
Cardiac disorders       
Angina pectoris  1  0/81 (0.00%)  1/34 (2.94%)  0/2 (0.00%) 
Gastrointestinal disorders       
Abdominal pain lower  1  1/81 (1.23%)  0/34 (0.00%)  0/2 (0.00%) 
General disorders       
Non-cardiac chest pain  1  0/81 (0.00%)  1/34 (2.94%)  0/2 (0.00%) 
Infections and infestations       
Bursitis infective  1  1/81 (1.23%)  0/34 (0.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders       
Costochondritis  1  1/81 (1.23%)  0/34 (0.00%)  0/2 (0.00%) 
Nervous system disorders       
Headache  1  0/81 (0.00%)  1/34 (2.94%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pleurisy  1  1/81 (1.23%)  0/34 (0.00%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash generalised  1  1/81 (1.23%)  0/34 (0.00%)  1/2 (50.00%) 
Drug rash with eosinophilia and systemic symptoms  1  1/81 (1.23%)  0/34 (0.00%)  0/2 (0.00%) 
Rash maculo-papular  1  0/81 (0.00%)  1/34 (2.94%)  0/2 (0.00%) 
Urticaria  1  1/81 (1.23%)  0/34 (0.00%)  0/2 (0.00%) 
Vascular disorders       
Hypertension  1  0/81 (0.00%)  1/34 (2.94%)  0/2 (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 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Other
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   77/81 (95.06%)   31/34 (91.18%)   2/2 (100.00%) 
Blood and lymphatic system disorders       
Anaemia  1  22/81 (27.16%)  7/34 (20.59%)  0/2 (0.00%) 
Neutropenia  1  6/81 (7.41%)  2/34 (5.88%)  0/2 (0.00%) 
Eye disorders       
Vision blurred  1  3/81 (3.70%)  2/34 (5.88%)  0/2 (0.00%) 
Gastrointestinal disorders       
Nausea  1  20/81 (24.69%)  11/34 (32.35%)  1/2 (50.00%) 
Diarrhoea  1  19/81 (23.46%)  6/34 (17.65%)  0/2 (0.00%) 
Haemorrhoids  1  9/81 (11.11%)  4/34 (11.76%)  0/2 (0.00%) 
Anorectal discomfort  1  7/81 (8.64%)  3/34 (8.82%)  0/2 (0.00%) 
Constipation  1  3/81 (3.70%)  6/34 (17.65%)  0/2 (0.00%) 
Vomiting  1  5/81 (6.17%)  2/34 (5.88%)  0/2 (0.00%) 
Abdominal pain  1  5/81 (6.17%)  1/34 (2.94%)  0/2 (0.00%) 
Dyspepsia  1  4/81 (4.94%)  2/34 (5.88%)  0/2 (0.00%) 
Stomatitis  1  1/81 (1.23%)  4/34 (11.76%)  0/2 (0.00%) 
Flatulence  1  0/81 (0.00%)  2/34 (5.88%)  0/2 (0.00%) 
Dry mouth  1  2/81 (2.47%)  2/34 (5.88%)  0/2 (0.00%) 
General disorders       
Fatigue  1  30/81 (37.04%)  21/34 (61.76%)  1/2 (50.00%) 
Influenza like illness  1  17/81 (20.99%)  10/34 (29.41%)  1/2 (50.00%) 
Pyrexia  1  16/81 (19.75%)  6/34 (17.65%)  0/2 (0.00%) 
Chills  1  11/81 (13.58%)  4/34 (11.76%)  0/2 (0.00%) 
Asthenia  1  9/81 (11.11%)  3/34 (8.82%)  0/2 (0.00%) 
Injection site erythema  1  9/81 (11.11%)  2/34 (5.88%)  0/2 (0.00%) 
Irritability  1  6/81 (7.41%)  4/34 (11.76%)  1/2 (50.00%) 
Pain  1  5/81 (6.17%)  4/34 (11.76%)  0/2 (0.00%) 
Oedema peripheral  1  4/81 (4.94%)  3/34 (8.82%)  0/2 (0.00%) 
Infections and infestations       
Sinusitis  1  4/81 (4.94%)  4/34 (11.76%)  0/2 (0.00%) 
Nasopharyngitis  1  3/81 (3.70%)  2/34 (5.88%)  0/2 (0.00%) 
Urinary tract infection  1  5/81 (6.17%)  0/34 (0.00%)  0/2 (0.00%) 
Fungal skin infection  1  0/81 (0.00%)  2/34 (5.88%)  0/2 (0.00%) 
Investigations       
Haemoglobin decreased  1  2/81 (2.47%)  2/34 (5.88%)  0/2 (0.00%) 
Blood triglycerides increased  1  1/81 (1.23%)  2/34 (5.88%)  0/2 (0.00%) 
Metabolism and nutrition disorders       
Anorexia  1  6/81 (7.41%)  1/34 (2.94%)  0/2 (0.00%) 
Decreased appetite  1  4/81 (4.94%)  3/34 (8.82%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  10/81 (12.35%)  5/34 (14.71%)  0/2 (0.00%) 
Arthralgia  1  11/81 (13.58%)  2/34 (5.88%)  0/2 (0.00%) 
Back pain  1  2/81 (2.47%)  3/34 (8.82%)  0/2 (0.00%) 
Muscle spasms  1  3/81 (3.70%)  2/34 (5.88%)  0/2 (0.00%) 
Musculoskeletal chest pain  1  0/81 (0.00%)  2/34 (5.88%)  0/2 (0.00%) 
Nervous system disorders       
Headache  1  23/81 (28.40%)  14/34 (41.18%)  0/2 (0.00%) 
Dizziness  1  6/81 (7.41%)  5/34 (14.71%)  0/2 (0.00%) 
Disturbance in attention  1  2/81 (2.47%)  2/34 (5.88%)  0/2 (0.00%) 
Psychiatric disorders       
Insomnia  1  14/81 (17.28%)  7/34 (20.59%)  1/2 (50.00%) 
Depression  1  9/81 (11.11%)  4/34 (11.76%)  0/2 (0.00%) 
Depressed mood  1  1/81 (1.23%)  2/34 (5.88%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  9/81 (11.11%)  4/34 (11.76%)  2/2 (100.00%) 
Dyspnoea exertional  1  4/81 (4.94%)  5/34 (14.71%)  0/2 (0.00%) 
Dyspnoea  1  3/81 (3.70%)  2/34 (5.88%)  1/2 (50.00%) 
Pharyngolaryngeal pain  1  5/81 (6.17%)  1/34 (2.94%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  34/81 (41.98%)  9/34 (26.47%)  2/2 (100.00%) 
Rash  1  23/81 (28.40%)  13/34 (38.24%)  1/2 (50.00%) 
Dry skin  1  10/81 (12.35%)  5/34 (14.71%)  0/2 (0.00%) 
Alopecia  1  8/81 (9.88%)  0/34 (0.00%)  0/2 (0.00%) 
Pruritus generalised  1  3/81 (3.70%)  3/34 (8.82%)  0/2 (0.00%) 
Rash papular  1  4/81 (4.94%)  2/34 (5.88%)  0/2 (0.00%) 
Hyperhidrosis  1  2/81 (2.47%)  3/34 (8.82%)  0/2 (0.00%) 
Psoriasis  1  1/81 (1.23%)  2/34 (5.88%)  0/2 (0.00%) 
Vascular disorders       
Hypertension  1  0/81 (0.00%)  3/34 (8.82%)  0/2 (0.00%) 
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: NCT00535847     History of Changes
Other Study ID Numbers: VX06-950-107
First Submitted: September 25, 2007
First Posted: September 26, 2007
Results First Submitted: June 22, 2011
Results First Posted: July 25, 2011
Last Update Posted: August 5, 2014