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Trial record 68 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection

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ClinicalTrials.gov Identifier: NCT01241760
Recruitment Status : Completed
First Posted : November 16, 2010
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Janssen Infectious Diseases BVBA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Genotype 1 Chronic Hepatitis C
Treatment Naive
Interventions Drug: Ribavirin
Drug: Telaprevir
Drug: Pegylated interferon alfa-2a
Enrollment 744
Recruitment Details This study evaluated the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with pegylated interferon and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.
Pre-assignment Details The study was conducted between 15 November 2010 and 02 August 2012 and recruited participants from 125 study centers in 14 countries worldwide. 744 participants were initially enrolled and 740 out of them randomly allocated to the 2 treatment arms.
Arm/Group Title T12(q8h)/PR T12(b.i.d.)/PR
Hide Arm/Group Description Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4. Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Period Title: Overall Study
Started 371 369
Completed 337 329
Not Completed 34 40
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             18             22
Withdrawal by Subject             13             13
Switch To Commercially Available Medicat             1             4
Not specified             1             1
Arm/Group Title T12(q8h)/PR T12(b.i.d.)/PR Total
Hide Arm/Group Description Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4. Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4. Total of all reporting groups
Overall Number of Baseline Participants 371 369 740
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 371 participants 369 participants 740 participants
<=18 years
3
   0.8%
0
   0.0%
3
   0.4%
Between 18 and 65 years
351
  94.6%
362
  98.1%
713
  96.4%
>=65 years
17
   4.6%
7
   1.9%
24
   3.2%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 371 participants 369 participants 740 participants
48
(18 to 70)
47.5
(19 to 70)
47.7
(18 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 371 participants 369 participants 740 participants
Female
136
  36.7%
160
  43.4%
296
  40.0%
Male
235
  63.3%
209
  56.6%
444
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 371 participants 369 participants 740 participants
Europe 192 179 371
North-America 126 137 263
Australia 28 28 56
Mexico 5 4 9
Brazil 20 21 41
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)
Hide Description The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
Time Frame End of trial, 12 weeks after last planned dose
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.
Arm/Group Title T12(q8h)/PR T12(b.i.d.)/PR
Hide Arm/Group Description:
Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Overall Number of Participants Analyzed 371 369
Measure Type: Number
Unit of Measure: percentage of participants with response
72.8 74.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T12(q8h)/PR, T12(b.i.d.)/PR
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the lower limit of the 95% confidence interval of the difference in proportions was above the pre-determined non-inferiority margin of -11%, non-inferiority was established.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments The 95% confidence interval of the difference in proportions was estimated using a logistic regression model.
Method of Estimation Estimation Parameter Difference in proportion of response, %
Estimated Value 1.5
Confidence Interval 95%
-4.9 to 12
Estimation Comments Observed data
2.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)
Hide Description The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12.
Time Frame End of trial, 24 weeks after last planned dose
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.
Arm/Group Title T12(q8h)/PR T12(b.i.d.)/PR
Hide Arm/Group Description:
Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Overall Number of Participants Analyzed 371 369
Measure Type: Number
Unit of Measure: percentage of participants with response
72.8 74.8
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)
Hide Description The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned). SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).
Time Frame End of trial, 72 weeks after the start of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.
Arm/Group Title T12(q8h)/PR T12(b.i.d.)/PR
Hide Arm/Group Description:
Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Overall Number of Participants Analyzed 371 369
Measure Type: Number
Unit of Measure: percentage of participants with response
69.0 70.2
4.Secondary Outcome
Title Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.
Hide Description The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.
Time Frame Baseline, Week 4 and Week 4+12.
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.
Arm/Group Title T12(q8h)/PR T12(b.i.d.)/PR
Hide Arm/Group Description:
Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Overall Number of Participants Analyzed 371 369
Measure Type: Number
Unit of Measure: percentage of participants with response
Baseline 0 0
at Week 4 67.4 69.4
at Week 4 and Week 12 63.1 66.1
5.Secondary Outcome
Title Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs
Hide Description The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.
Time Frame Week 4, 12, 24, 32, 40
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.
Arm/Group Title T12(q8h)/PR T12(b.i.d.)/PR
Hide Arm/Group Description:
Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Overall Number of Participants Analyzed 371 369
Measure Type: Number
Unit of Measure: percentage of participants
9.7 10.3
6.Secondary Outcome
Title Percentage of Participants Who Relapsed During Follow-up Period
Hide Description The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).
Time Frame During Follow-Up (24 weeks after the last dose of study drug)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on subjects with HCV RNA <25 IU/mL at the planned end of treatment, which included all randomized participants who received at least one dose of study drug and had data at the follow-up visit performed 24 weeks after the last dose of study drug.
Arm/Group Title T12(q8h)/PR T12(b.i.d.)/PR
Hide Arm/Group Description:
Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Overall Number of Participants Analyzed 293 300
Measure Type: Number
Unit of Measure: percentage of participants
7.2 7.7
7.Secondary Outcome
Title Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)
Hide Description The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.
Time Frame End of trial, 12 weeks after the last planned dose
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.
Arm/Group Title T12(q8h)/PR T12(b.i.d.)/PR
Hide Arm/Group Description:
Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
Overall Number of Participants Analyzed 371 369
Measure Type: Number
Unit of Measure: percentage of participants with response
CC genotype (n = 108; n = 103) 86.8 92.4
CT genotype (n = 207; n = 207) 67.8 67.5
TT genotype (n = 56; n = 59) 64.9 65.5
Time Frame Adverse event data were collected for the duration of study (12 weeks after the last dose).
Adverse Event Reporting Description The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
 
Arm/Group Title T12(q8h)/PR T12(b.i.d.)/PR Total
Hide Arm/Group Description Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4. Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4. All
All-Cause Mortality
T12(q8h)/PR T12(b.i.d.)/PR Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
T12(q8h)/PR T12(b.i.d.)/PR Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   35/371 (9.43%)   28/369 (7.59%)   63/740 (8.51%) 
Blood and lymphatic system disorders       
Anaemia * 1  14/371 (3.77%)  13/369 (3.52%)  27/740 (3.65%) 
Thrombocytopenia * 1  2/371 (0.54%)  0/369 (0.00%)  2/740 (0.27%) 
Leukopenia * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Neutropenia * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Pancytopenia * 1  1/371 (0.27%)  1/369 (0.27%)  2/740 (0.27%) 
Ear and labyrinth disorders       
Vertigo * 1  0/371 (0.00%)  2/369 (0.54%)  2/740 (0.27%) 
Gastrointestinal disorders       
Diarrhoea * 1  1/371 (0.27%)  1/369 (0.27%)  2/740 (0.27%) 
Haematochezia * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
General disorders       
Asthenia * 1  1/371 (0.27%)  1/369 (0.27%)  2/740 (0.27%) 
Chest discomfort * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Chest pain * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Fatigue * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Pyrexia * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Non-cardiac chest pain * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Hepatobiliary disorders       
Hyperbilirubinaemia * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Cholelithiasis * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Infections and infestations       
Abscess * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Cellulitis * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Escherichia sepsis * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Sinusitis * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Subcutaneous abscess * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Urinary tract infection * 1  1/371 (0.27%)  1/369 (0.27%)  2/740 (0.27%) 
Pneumonia * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Injury, poisoning and procedural complications       
Contusion * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Foot fracture * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Investigations       
Electrocardiogram t wave inversion * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Metabolism and nutrition disorders       
Dehydration * 1  2/371 (0.54%)  0/369 (0.00%)  2/740 (0.27%) 
Hypokalaemia * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Brain neoplasm * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Uterine leiomyoma * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Nervous system disorders       
Syncope * 1  3/371 (0.81%)  2/369 (0.54%)  5/740 (0.68%) 
Facial palsy * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Hemiparesis * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Hypoaesthesia * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Myoclonus * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Paraesthesia * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Psychiatric disorders       
Depression * 1  1/371 (0.27%)  1/369 (0.27%)  2/740 (0.27%) 
Suicide attempt * 1  1/371 (0.27%)  1/369 (0.27%)  2/740 (0.27%) 
Disorientation * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Mental status changes * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Renal and urinary disorders       
Renal failure acute * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Reproductive system and breast disorders       
Menorrhagia * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Postmenopausal haemorrhage * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Vaginal haemorrhage * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary hypertension * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Dyspnoea * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Pleural effusion * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Skin and subcutaneous tissue disorders       
Drug eruption * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Rash * 1  1/371 (0.27%)  2/369 (0.54%)  3/740 (0.41%) 
Rash generalised * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Urticaria * 1  1/371 (0.27%)  0/369 (0.00%)  1/740 (0.14%) 
Drug rash with eosinophilia and systemic symptoms * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
Pruritus * 1  0/371 (0.00%)  1/369 (0.27%)  1/740 (0.14%) 
*
Indicates events were collected by non-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%
T12(q8h)/PR T12(b.i.d.)/PR Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   359/371 (96.77%)   358/369 (97.02%)   717/740 (96.89%) 
Blood and lymphatic system disorders       
Anaemia * 1  148/371 (39.89%)  155/369 (42.01%)  303/740 (40.95%) 
Neutropenia * 1  30/371 (8.09%)  36/369 (9.76%)  66/740 (8.92%) 
Thrombocytopenia * 1  30/371 (8.09%)  29/369 (7.86%)  59/740 (7.97%) 
Eye disorders       
Vision blurred * 1  17/371 (4.58%)  20/369 (5.42%)  37/740 (5.00%) 
Gastrointestinal disorders       
Nausea * 1  143/371 (38.54%)  129/369 (34.96%)  272/740 (36.76%) 
Diarrhoea * 1  71/371 (19.14%)  49/369 (13.28%)  120/740 (16.22%) 
Anal pruritus * 1  43/371 (11.59%)  30/369 (8.13%)  73/740 (9.86%) 
Vomiting * 1  41/371 (11.05%)  38/369 (10.30%)  79/740 (10.68%) 
Anorectal discomfort * 1  36/371 (9.70%)  39/369 (10.57%)  75/740 (10.14%) 
Haemorrhoids * 1  33/371 (8.89%)  26/369 (7.05%)  59/740 (7.97%) 
Dry mouth * 1  23/371 (6.20%)  24/369 (6.50%)  47/740 (6.35%) 
Dyspepsia * 1  22/371 (5.93%)  15/369 (4.07%)  37/740 (5.00%) 
Proctalgia * 1  21/371 (5.66%)  18/369 (4.88%)  39/740 (5.27%) 
Abdominal pain * 1  19/371 (5.12%)  10/369 (2.71%)  29/740 (3.92%) 
General disorders       
Fatigue * 1  178/371 (47.98%)  173/369 (46.88%)  351/740 (47.43%) 
Pyrexia * 1  78/371 (21.02%)  62/369 (16.80%)  140/740 (18.92%) 
Asthenia * 1  72/371 (19.41%)  65/369 (17.62%)  137/740 (18.51%) 
Influenza like illness * 1  60/371 (16.17%)  75/369 (20.33%)  135/740 (18.24%) 
Chills * 1  43/371 (11.59%)  22/369 (5.96%)  65/740 (8.78%) 
Injection site reaction * 1  25/371 (6.74%)  23/369 (6.23%)  48/740 (6.49%) 
Metabolism and nutrition disorders       
Anorexia * 1  36/371 (9.70%)  30/369 (8.13%)  66/740 (8.92%) 
Decreased appetite * 1  19/371 (5.12%)  22/369 (5.96%)  41/740 (5.54%) 
Musculoskeletal and connective tissue disorders       
Myalgia * 1  41/371 (11.05%)  33/369 (8.94%)  74/740 (10.00%) 
Arthralgia * 1  24/371 (6.47%)  25/369 (6.78%)  49/740 (6.62%) 
Nervous system disorders       
Headache * 1  108/371 (29.11%)  87/369 (23.58%)  195/740 (26.35%) 
Dysgeusia * 1  46/371 (12.40%)  36/369 (9.76%)  82/740 (11.08%) 
Dizziness * 1  30/371 (8.09%)  41/369 (11.11%)  71/740 (9.59%) 
Psychiatric disorders       
Insomnia * 1  68/371 (18.33%)  69/369 (18.70%)  137/740 (18.51%) 
Mood altered * 1  47/371 (12.67%)  37/369 (10.03%)  84/740 (11.35%) 
Depression * 1  36/371 (9.70%)  27/369 (7.32%)  63/740 (8.51%) 
Anxiety * 1  20/371 (5.39%)  26/369 (7.05%)  46/740 (6.22%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  44/371 (11.86%)  39/369 (10.57%)  83/740 (11.22%) 
Cough * 1  35/371 (9.43%)  36/369 (9.76%)  71/740 (9.59%) 
Dyspnoea exertional * 1  19/371 (5.12%)  17/369 (4.61%)  36/740 (4.86%) 
Skin and subcutaneous tissue disorders       
Pruritus * 1  158/371 (42.59%)  158/369 (42.82%)  316/740 (42.70%) 
Rash * 1  133/371 (35.85%)  129/369 (34.96%)  262/740 (35.41%) 
Dry skin * 1  35/371 (9.43%)  43/369 (11.65%)  78/740 (10.54%) 
Erythema * 1  22/371 (5.93%)  20/369 (5.42%)  42/740 (5.68%) 
*
Indicates events were collected by non-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.
If the PI (Investigator) wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Compound Development Team Leader
Organization: Janssen Infectious Diseases BVBA
Phone: 32 14 64 13 70
Layout table for additonal information
Responsible Party: Janssen Infectious Diseases BVBA
ClinicalTrials.gov Identifier: NCT01241760     History of Changes
Other Study ID Numbers: CR013711
OPTIMIZE-HCV ( Other Identifier: Janssen Infectious Diseases BVBA )
VX-950-C211 ( Other Identifier: Janssen Infectious Diseases BVBA )
2010-021628-84 ( EudraCT Number )
First Submitted: October 28, 2010
First Posted: November 16, 2010
Results First Submitted: September 23, 2013
Results First Posted: June 4, 2014
Last Update Posted: June 4, 2014