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

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Tibotec BVBA
ClinicalTrials.gov Identifier:
NCT00703118
First received: June 19, 2008
Last updated: December 5, 2013
Last verified: December 2013
Results First Received: July 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: Telaprevir
Drug: Peg-IFN-alfa-2a
Drug: Ribavirin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
T12/PR48 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
T12(DS)/PR48 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
Pbo/PR48 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses

Participant Flow:   Overall Study
    T12/PR48   T12(DS)/PR48   Pbo/PR48
STARTED   266   264   132 
COMPLETED   245   248   110 
NOT COMPLETED   21   16   22 
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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
T12/PR48 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
T12(DS)/PR48 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
Pbo/PR48 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Total Total of all reporting groups

Baseline Measures
   T12/PR48   T12(DS)/PR48   Pbo/PR48   Total 
Overall Participants Analyzed 
[Units: Participants]
 266   264   132   662 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.7  (8.51)   51  (8.24)   49.9  (9.74)   50.6  (8.66) 
Gender 
[Units: Participants]
       
Female   83   75   44   202 
Male   183   189   88   460 
Race/Ethnicity, Customized 
[Units: 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 
[Units: Participants]
       
>= 45 years   64   55   40   159 
Between 45 and 65 years   197   201   85   483 
>= 65 years   5   8   7   20 


  Outcome Measures
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1.  Primary:   Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned   [ Time Frame: Week 72 ]

2.  Secondary:   Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4   [ Time Frame: Week 4 ]

3.  Secondary:   Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)   [ Time Frame: Week 48 ]

4.  Secondary:   Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned   [ Time Frame: Week 60 ]

5.  Secondary:   Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8   [ Time Frame: Week 4, Week 6, or Week 8 ]

6.  Secondary:   Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)   [ Time Frame: Up to Week 72 ]

7.  Secondary:   Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4   [ Time Frame: Baseline (Day 1) to Week 4 ]

8.  Secondary:   Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12   [ Time Frame: Week 4 and Week 12 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame 72 weeks
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
T12/PR48 - TVR/PBO TREATMENT 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
T12(DS)/PR48 - TVR/PBO TREATMENT 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
Pbo/PR48 - TVR/PBO TREATMENT 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
T12/PR48 - OVERALL TREATMENT 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
T12(DS)/PR48 - OVERALL TREATMENT 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
Pbo/PR48 - OVERALL TREATMENT 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the overall treatment phase

Other 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
Total, other (not including serious) adverse events             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   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             
# participants affected / at risk   91/266 (34.21%)   88/264 (33.33%)   24/132 (18.18%)   99/266 (37.22%)   95/264 (35.98%)   25/132 (18.94%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 11.0



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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