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  
Number of Participants  
[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     255/264     126/132     257/266     260/264     126/132  
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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