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A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

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: NCT00703118
Recruitment Status : Completed
First Posted : June 23, 2008
Results First Posted : August 11, 2011
Last Update Posted : January 22, 2014
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Tibotec BVBA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: Telaprevir
Drug: Peg-IFN-alfa-2a
Drug: Ribavirin
Drug: Placebo
Enrollment 663
Recruitment Details The study was conducted at 105 sites in 17 countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Switzerland, Germany, Spain, France, United Kingdom, Israel, Italy, Netherlands, Poland, Sweden, and the United States.
Pre-assignment Details 662 participants were treated (266 participants in the T12/PR48 group, 264 participants in the T12(DS)/PR48 group, and 132 participants in the Pbo/PR48 group) in this study.
Arm/Group Title T12/PR48 T12(DS)/PR48 Pbo/PR48
Hide Arm/Group Description 12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses 4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Period Title: Overall Study
Started 266 264 132
Completed 245 248 110
Not Completed 21 16 22
Reason Not Completed
Adverse Event             1             2             2
Subject Ineligible To Continue The Trial             6             3             2
Lost to Follow-up             6             4             4
Withdrawal by Subject             8             7             13
Not specified             0             0             1
Arm/Group Title T12/PR48 T12(DS)/PR48 Pbo/PR48 Total
Hide Arm/Group Description 12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses 4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses Total of all reporting groups
Overall Number of Baseline Participants 266 264 132 662
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 266 participants 264 participants 132 participants 662 participants
50.7  (8.51) 51  (8.24) 49.9  (9.74) 50.6  (8.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 266 participants 264 participants 132 participants 662 participants
Female
83
  31.2%
75
  28.4%
44
  33.3%
202
  30.5%
Male
183
  68.8%
189
  71.6%
88
  66.7%
460
  69.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 266 participants 264 participants 132 participants 662 participants
Asian 6 2 3 11
Black or African American 11 8 11 30
White 246 252 117 615
Other 3 2 1 6
AgeCategoricalOther  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 266 participants 264 participants 132 participants 662 participants
>= 45 years 64 55 40 159
Between 45 and 65 years 197 201 85 483
>= 65 years 5 8 7 20
1.Primary Outcome
Title Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned
Hide Description SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All randomized participants who received at least one dose of study medication.
Arm/Group Title T12/PR48 T12(DS)/PR48 Pbo/PR48
Hide Arm/Group Description:
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Overall Number of Participants Analyzed 266 264 132
Measure Type: Number
Unit of Measure: Participants
171 175 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T12/PR48, Pbo/PR48
Comments Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure
Method Regression, Logistic
Comments Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate
Method of Estimation Estimation Parameter Difference in percentage of response
Estimated Value 46.8
Confidence Interval (2-Sided) 95%
36.8 to 56.7
Estimation Comments Difference in percentage of response was estimated through the logistic regression model.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection T12(DS)/PR48, Pbo/PR48
Comments Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48 or T12(DS)/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12(DS)/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure
Method Regression, Logistic
Comments Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate
Method of Estimation Estimation Parameter Difference in percentage of response
Estimated Value 49.8
Confidence Interval (2-Sided) 95%
39.9 to 59.7
Estimation Comments Difference in percentage of response was estimated through the logistic regression model.
2.Secondary Outcome
Title Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4
Hide Description RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.
Arm/Group Title T12/PR48 T12(DS)/PR48 Pbo/PR48
Hide Arm/Group Description:
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Overall Number of Participants Analyzed 266 264 132
Measure Type: Number
Unit of Measure: Participants
152 188 3
3.Secondary Outcome
Title Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)
Hide Description [Not Specified]
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.
Arm/Group Title T12/PR48 T12(DS)/PR48 Pbo/PR48
Hide Arm/Group Description:
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Overall Number of Participants Analyzed 266 264 132
Measure Type: Number
Unit of Measure: Participants
184 191 49
4.Secondary Outcome
Title Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned
Hide Description SVR12 planned was defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks after the last planned dose of study medication (SVR12 planned).
Time Frame Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.
Arm/Group Title T12/PR48 T12(DS)/PR48 Pbo/PR48
Hide Arm/Group Description:
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Overall Number of Participants Analyzed 266 264 132
Measure Type: Number
Unit of Measure: Participants
175 178 22
5.Secondary Outcome
Title Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8
Hide Description Telaprevir stopping rule is defined as having Hepatitis C virus (HCV) ribonucleic acid (RNA) levels >100 IU/mL at Week 4, Week 6, or Week 8 after start of telaprevir.
Time Frame Week 4, Week 6, or Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.
Arm/Group Title T12/PR48 T12(DS)/PR48
Hide Arm/Group Description:
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Overall Number of Participants Analyzed 266 264
Measure Type: Number
Unit of Measure: Participants
Week 4 16 14
Week 6 5 2
Week 8 2 0
6.Secondary Outcome
Title Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)
Hide Description Viral relapse was defined as having confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels during entire follow-up period (up to Week 72).
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.
Arm/Group Title T12/PR48 T12(DS)/PR48 Pbo/PR48
Hide Arm/Group Description:
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Overall Number of Participants Analyzed 266 264 132
Measure Type: Number
Unit of Measure: Participants
26 27 33
7.Secondary Outcome
Title Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4
Hide Description [Not Specified]
Time Frame Baseline (Day 1) to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.
Arm/Group Title T12/PR48 T12(DS)/PR48 Pbo/PR48
Hide Arm/Group Description:
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Overall Number of Participants Analyzed 245 240 121
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.5  (1.06) -2.0  (1.42) -1.9  (1.40)
8.Secondary Outcome
Title Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12
Hide Description Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.
Time Frame Week 4 and Week 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 participants who received at least one dose of study medication.
Arm/Group Title T12/PR48 T12(DS)/PR48 Pbo/PR48
Hide Arm/Group Description:
12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Overall Number of Participants Analyzed 266 264 132
Measure Type: Number
Unit of Measure: Participants
141 180 3
Time Frame 72 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title T12/PR48 - TVR/PBO TREATMENT T12(DS)/PR48 - TVR/PBO TREATMENT Pbo/PR48 - TVR/PBO TREATMENT T12/PR48 - OVERALL TREATMENT T12(DS)/PR48 - OVERALL TREATMENT Pbo/PR48 - OVERALL TREATMENT
Hide Arm/Group Description 12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase 4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase 12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase 4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the overall treatment phase
All-Cause Mortality
T12/PR48 - TVR/PBO TREATMENT T12(DS)/PR48 - TVR/PBO TREATMENT Pbo/PR48 - TVR/PBO TREATMENT T12/PR48 - OVERALL TREATMENT T12(DS)/PR48 - OVERALL TREATMENT Pbo/PR48 - OVERALL TREATMENT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
T12/PR48 - TVR/PBO TREATMENT T12(DS)/PR48 - TVR/PBO TREATMENT Pbo/PR48 - TVR/PBO TREATMENT T12/PR48 - OVERALL TREATMENT T12(DS)/PR48 - OVERALL TREATMENT Pbo/PR48 - OVERALL TREATMENT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/266 (6.77%)   17/264 (6.44%)   4/132 (3.03%)   33/266 (12.41%)   32/264 (12.12%)   7/132 (5.30%) 
Blood and lymphatic system disorders             
Anaemia  1  4/266 (1.50%)  5/264 (1.89%)  1/132 (0.76%)  6/266 (2.26%)  7/264 (2.65%)  1/132 (0.76%) 
Febrile neutropenia  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Pancytopenia  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  1/264 (0.38%)  0/132 (0.00%) 
Thrombocytopenia  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Cardiac disorders             
Acute myocardial infarction  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  3/266 (1.13%)  0/264 (0.00%)  0/132 (0.00%) 
Atrial fibrillation  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  2/264 (0.76%)  1/132 (0.76%) 
Cardiac valve disease  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Myocardial infarction  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Supraventricular tachycardia  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Ear and labyrinth disorders             
Sudden hearing loss  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Endocrine disorders             
Basedow's disease  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Eye disorders             
Retinal detachment  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Gastrointestinal disorders             
Abdominal pain  1  0/266 (0.00%)  0/264 (0.00%)  1/132 (0.76%)  0/266 (0.00%)  1/264 (0.38%)  1/132 (0.76%) 
Anal fissure  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Caecitis  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Colitis  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  0/264 (0.00%)  1/132 (0.76%) 
Gastrointestinal haemorrhage  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Pancreatitis  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Pancreatitis acute  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  1/264 (0.38%)  0/132 (0.00%) 
General disorders             
General physical health deterioration  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Pyrexia  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Infections and infestations             
Appendicitis  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Bronchitis  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  2/266 (0.75%)  0/264 (0.00%)  0/132 (0.00%) 
Erysipelas  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Folliculitis  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Helicobacter gastritis  1  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Pneumonia  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  1/132 (0.76%) 
Post procedural infection  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Pyelonephritis  1  0/266 (0.00%)  0/264 (0.00%)  1/132 (0.76%)  0/266 (0.00%)  0/264 (0.00%)  1/132 (0.76%) 
Rectal abscess  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Sepsis  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  2/264 (0.76%)  0/132 (0.00%) 
Sinusitis  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Tooth abscess  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Urinary tract infection  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  1/264 (0.38%)  0/132 (0.00%) 
Injury, poisoning and procedural complications             
Injection site reaction  1  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Animal scratch  1  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Ankle fracture  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Femoral neck fracture  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Multiple drug overdose  1  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Investigations             
Blood corticotrophin decreased  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Weight decreased  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Metabolism and nutrition disorders             
Anorexia  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Diabetes mellitus  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Bronchial carcinoma  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Gastric cancer  1  0/266 (0.00%)  2/264 (0.76%)  0/132 (0.00%)  0/266 (0.00%)  2/264 (0.76%)  0/132 (0.00%) 
Hepatic neoplasm malignant  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  2/266 (0.75%)  0/264 (0.00%)  0/132 (0.00%) 
Histiocytosis haematophagic  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Lung neoplasm malignant  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Nervous system disorders             
Cerebral thrombosis  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  0/264 (0.00%)  1/132 (0.76%) 
Coma  1  0/266 (0.00%)  0/264 (0.00%)  1/132 (0.76%)  0/266 (0.00%)  0/264 (0.00%)  1/132 (0.76%) 
Lethargy  1  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Subarachnoid haemorrhage  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Syncope  1  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%)  1/266 (0.38%)  1/264 (0.38%)  0/132 (0.00%) 
Psychiatric disorders             
Delirium  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Depression  1  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Insomnia  1  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Substance abuse  1  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Renal and urinary disorders             
Renal cyst  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Renal failure  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Urinary bladder polyp  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Reproductive system and breast disorders             
Prostatitis  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Pulmonary embolism  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Skin and subcutaneous tissue disorders             
Dermatitis  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Eczema  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Erythema multiforme  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Pruritus  1  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (0.00%) 
Pustular psoriasis  1  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Rash  1  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Toxic skin eruption  1  0/266 (0.00%)  2/264 (0.76%)  0/132 (0.00%)  0/266 (0.00%)  2/264 (0.76%)  0/132 (0.00%) 
Vascular disorders             
Orthostatic hypotension  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  0/266 (0.00%)  1/264 (0.38%)  0/132 (0.00%) 
Peripheral artery aneurysm  1  0/266 (0.00%)  0/264 (0.00%)  0/132 (0.00%)  1/266 (0.38%)  0/264 (0.00%)  0/132 (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%
T12/PR48 - TVR/PBO TREATMENT T12(DS)/PR48 - TVR/PBO TREATMENT Pbo/PR48 - TVR/PBO TREATMENT T12/PR48 - OVERALL TREATMENT T12(DS)/PR48 - OVERALL TREATMENT Pbo/PR48 - OVERALL TREATMENT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   253/266 (95.11%)   255/264 (96.59%)   126/132 (95.45%)   257/266 (96.62%)   260/264 (98.48%)   126/132 (95.45%) 
Blood and lymphatic system disorders             
Anaemia  1  70/266 (26.32%)  82/264 (31.06%)  17/132 (12.88%)  78/266 (29.32%)  93/264 (35.23%)  19/132 (14.39%) 
Leukopenia  1  23/266 (8.65%)  13/264 (4.92%)  9/132 (6.82%)  27/266 (10.15%)  20/264 (7.58%)  11/132 (8.33%) 
Neutropenia  1  17/266 (6.39%)  24/264 (9.09%)  12/132 (9.09%)  38/266 (14.29%)  35/264 (13.26%)  14/132 (10.61%) 
Thrombocytopenia  1  7/266 (2.63%)  14/264 (5.30%)  6/132 (4.55%)  9/266 (3.38%)  16/264 (6.06%)  7/132 (5.30%) 
Eye disorders             
Vision blurred  1  10/266 (3.76%)  7/264 (2.65%)  2/132 (1.52%)  16/266 (6.02%)  10/264 (3.79%)  3/132 (2.27%) 
Gastrointestinal disorders             
Abdominal pain  1  32/266 (12.03%)  29/264 (10.98%)  16/132 (12.12%)  43/266 (16.17%)  36/264 (13.64%)  21/132 (15.91%) 
Anal pruritus  1  14/266 (5.26%)  15/264 (5.68%)  0/132 (0.00%)  14/266 (5.26%)  15/264 (5.68%)  0/132 (0.00%) 
Anorectal discomfort  1  20/266 (7.52%)  11/264 (4.17%)  0/132 (0.00%)  21/266 (7.89%)  11/264 (4.17%)  0/132 (0.00%) 
Constipation  1  11/266 (4.14%)  11/264 (4.17%)  5/132 (3.79%)  20/266 (7.52%)  17/264 (6.44%)  5/132 (3.79%) 
Diarrhoea  1  60/266 (22.56%)  64/264 (24.24%)  16/132 (12.12%)  66/266 (24.81%)  69/264 (26.14%)  18/132 (13.64%) 
Dry mouth  1  23/266 (8.65%)  20/264 (7.58%)  12/132 (9.09%)  25/266 (9.40%)  21/264 (7.95%)  12/132 (9.09%) 
Dyspepsia  1  13/266 (4.89%)  15/264 (5.68%)  10/132 (7.58%)  13/266 (4.89%)  18/264 (6.82%)  11/132 (8.33%) 
Haemorrhoids  1  38/266 (14.29%)  28/264 (10.61%)  7/132 (5.30%)  40/266 (15.04%)  32/264 (12.12%)  9/132 (6.82%) 
Nausea  1  89/266 (33.46%)  80/264 (30.30%)  31/132 (23.48%)  94/266 (35.34%)  87/264 (32.95%)  31/132 (23.48%) 
Vomiting  1  29/266 (10.90%)  28/264 (10.61%)  10/132 (7.58%)  37/266 (13.91%)  31/264 (11.74%)  11/132 (8.33%) 
General disorders             
Asthenia  1  49/266 (18.42%)  55/264 (20.83%)  35/132 (26.52%)  51/266 (19.17%)  60/264 (22.73%)  38/132 (28.79%) 
Chills  1  41/266 (15.41%)  31/264 (11.74%)  19/132 (14.39%)  42/266 (15.79%)  31/264 (11.74%)  19/132 (14.39%) 
Fatigue  1  138/266 (51.88%)  124/264 (46.97%)  51/132 (38.64%)  145/266 (54.51%)  131/264 (49.62%)  53/132 (40.15%) 
Influenza like illness  1  85/266 (31.95%)  90/264 (34.09%)  33/132 (25.00%)  85/266 (31.95%)  94/264 (35.61%)  33/132 (25.00%) 
Irritability  1  31/266 (11.65%)  36/264 (13.64%)  19/132 (14.39%)  36/266 (13.53%)  38/264 (14.39%)  21/132 (15.91%) 
Pain  1  14/266 (5.26%)  5/264 (1.89%)  3/132 (2.27%)  16/266 (6.02%)  5/264 (1.89%)  4/132 (3.03%) 
Pyrexia  1  57/266 (21.43%)  63/264 (23.86%)  32/132 (24.24%)  59/266 (22.18%)  71/264 (26.89%)  36/132 (27.27%) 
Infections and infestations             
Nasopharyngitis  1  6/266 (2.26%)  10/264 (3.79%)  7/132 (5.30%)  8/266 (3.01%)  11/264 (4.17%)  8/132 (6.06%) 
Injury, poisoning and procedural complications             
Injection site erythema  1  14/266 (5.26%)  19/264 (7.20%)  5/132 (3.79%)  15/266 (5.64%)  20/264 (7.58%)  6/132 (4.55%) 
Investigations             
Weight decreased  1  7/266 (2.63%)  5/264 (1.89%)  6/132 (4.55%)  12/266 (4.51%)  18/264 (6.82%)  7/132 (5.30%) 
Metabolism and nutrition disorders             
Anorexia  1  32/266 (12.03%)  33/264 (12.50%)  19/132 (14.39%)  33/266 (12.41%)  36/264 (13.64%)  19/132 (14.39%) 
Decreased appetite  1  16/266 (6.02%)  19/264 (7.20%)  7/132 (5.30%)  17/266 (6.39%)  23/264 (8.71%)  9/132 (6.82%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  28/266 (10.53%)  27/264 (10.23%)  19/132 (14.39%)  36/266 (13.53%)  31/264 (11.74%)  20/132 (15.15%) 
Back pain  1  14/266 (5.26%)  14/264 (5.30%)  8/132 (6.06%)  25/266 (9.40%)  21/264 (7.95%)  9/132 (6.82%) 
Muscle spasms  1  10/266 (3.76%)  6/264 (2.27%)  4/132 (3.03%)  14/266 (5.26%)  10/264 (3.79%)  4/132 (3.03%) 
Myalgia  1  35/266 (13.16%)  40/264 (15.15%)  24/132 (18.18%)  45/266 (16.92%)  42/264 (15.91%)  24/132 (18.18%) 
Pain in extremity  1  9/266 (3.38%)  7/264 (2.65%)  2/132 (1.52%)  15/266 (5.64%)  12/264 (4.55%)  2/132 (1.52%) 
Nervous system disorders             
Disturbance in attention  1  5/266 (1.88%)  13/264 (4.92%)  8/132 (6.06%)  7/266 (2.63%)  17/264 (6.44%)  9/132 (6.82%) 
Dizziness  1  18/266 (6.77%)  23/264 (8.71%)  5/132 (3.79%)  19/266 (7.14%)  27/264 (10.23%)  7/132 (5.30%) 
Dysgeusia  1  32/266 (12.03%)  27/264 (10.23%)  8/132 (6.06%)  33/266 (12.41%)  32/264 (12.12%)  8/132 (6.06%) 
Headache  1  106/266 (39.85%)  101/264 (38.26%)  46/132 (34.85%)  112/266 (42.11%)  109/264 (41.29%)  49/132 (37.12%) 
Psychiatric disorders             
Anxiety  1  6/266 (2.26%)  21/264 (7.95%)  11/132 (8.33%)  9/266 (3.38%)  26/264 (9.85%)  13/132 (9.85%) 
Depression  1  20/266 (7.52%)  33/264 (12.50%)  14/132 (10.61%)  24/266 (9.02%)  35/264 (13.26%)  19/132 (14.39%) 
Insomnia  1  55/266 (20.68%)  70/264 (26.52%)  29/132 (21.97%)  68/266 (25.56%)  84/264 (31.82%)  34/132 (25.76%) 
Sleep disorder  1  10/266 (3.76%)  8/264 (3.03%)  7/132 (5.30%)  11/266 (4.14%)  11/264 (4.17%)  10/132 (7.58%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1  44/266 (16.54%)  49/264 (18.56%)  23/132 (17.42%)  62/266 (23.31%)  66/264 (25.00%)  26/132 (19.70%) 
Dyspnoea  1  27/266 (10.15%)  41/264 (15.53%)  16/132 (12.12%)  32/266 (12.03%)  50/264 (18.94%)  17/132 (12.88%) 
Dyspnoea exertional  1  11/266 (4.14%)  17/264 (6.44%)  5/132 (3.79%)  15/266 (5.64%)  20/264 (7.58%)  6/132 (4.55%) 
Pharyngolaryngeal pain  1  12/266 (4.51%)  12/264 (4.55%)  5/132 (3.79%)  13/266 (4.89%)  18/264 (6.82%)  8/132 (6.06%) 
Skin and subcutaneous tissue disorders             
Alopecia  1  22/266 (8.27%)  19/264 (7.20%)  12/132 (9.09%)  38/266 (14.29%)  40/264 (15.15%)  17/132 (12.88%) 
Dry skin  1  36/266 (13.53%)  45/264 (17.05%)  21/132 (15.91%)  44/266 (16.54%)  53/264 (20.08%)  21/132 (15.91%) 
Erythema  1  19/266 (7.14%)  15/264 (5.68%)  5/132 (3.79%)  27/266 (10.15%)  16/264 (6.06%)  7/132 (5.30%) 
Hyperhidrosis  1  3/266 (1.13%)  9/264 (3.41%)  6/132 (4.55%)  6/266 (2.26%)  9/264 (3.41%)  7/132 (5.30%) 
Pruritus  1  132/266 (49.62%)  130/264 (49.24%)  35/132 (26.52%)  138/266 (51.88%)  132/264 (50.00%)  36/132 (27.27%) 
Rash  1  91/266 (34.21%)  88/264 (33.33%)  24/132 (18.18%)  99/266 (37.22%)  95/264 (35.98%)  25/132 (18.94%) 
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
Name/Title: Medical Leader
Organization: Tibotec
Phone: 1 609 730-3174
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tibotec BVBA
ClinicalTrials.gov Identifier: NCT00703118     History of Changes
Other Study ID Numbers: CR014842
VX-950-TIDP24-C216 ( Other Identifier: Tibotec-Virco Virology BVBA )
First Submitted: June 19, 2008
First Posted: June 23, 2008
Results First Submitted: July 18, 2011
Results First Posted: August 11, 2011
Last Update Posted: January 22, 2014