A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 HCV

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00627926
First received: February 22, 2008
Last updated: June 22, 2011
Last verified: June 2011
Results First Received: June 22, 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
Interventions: Biological: peginterferon alfa-2a
Drug: telaprevir
Drug: ribavirin
Other: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo12/PR48 Placebo matching telaprevir in combination with peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin
T8/Placebo4/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus peginterferon alfa-2a and ribavirin, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
T12/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.

Participant Flow:   Overall Study
    Placebo12/PR48     T8/Placebo4/PR24or48     T12/PR24or48  
STARTED     361     364     363  
COMPLETED     202     260     268  
NOT COMPLETED     159     104     95  
Adverse Event                 26                 37                 36  
Death                 1                 0                 0  
Lost to Follow-up                 4                 3                 4  
Withdrawal by Subject                 2                 1                 0  
Lack of Efficacy                 118                 40                 38  
noncompliance/other                 8                 23                 17  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Placebo12/PR48 Placebo matching telaprevir in combination with peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin
T8/Placebo4/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus peginterferon alfa-2a and ribavirin, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
T12/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
Total Total of all reporting groups

Baseline Measures
    Placebo12/PR48     T8/Placebo4/PR24or48     T12/PR24or48     Total  
Number of Participants  
[units: participants]
  361     364     363     1088  
Age  
[units: participants]
       
<=18 years     1     0     0     1  
Between 18 and 65 years     357     359     353     1069  
>=65 years     3     5     10     18  
Age  
[units: years]
Mean ± Standard Deviation
  46.8  ± 10.0     47.0  ± 10.9     46.5  ± 10.8     46.8  ± 10.6  
Gender  
[units: participants]
       
Female     150     153     149     452  
Male     211     211     214     636  
Region of Enrollment  
[units: participants]
       
North America     214     227     214     655  
Europe     106     100     104     310  
Argentina     8     6     3     17  
Australia     14     14     18     46  
Israel     19     17     24     60  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Planned Dose of Study Treatment   [ Time Frame: 24 weeks after last dose of study treatment ]

2.  Secondary:   Proportion of Subjects Who Have Undetectable HCV RNA at Week 72   [ Time Frame: 24 weeks after last planned dose for subjects with a planned treatment duration of 48 weeks, and 48 weeks after last planned dose for subjects with a planned treatment duration of 24 weeks ]

3.  Secondary:   Proportion of Subjects Achieving a Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment   [ Time Frame: 4 weeks after starting study treatment ]

4.  Secondary:   Proportion of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12   [ Time Frame: Week 4 and Week 12 ]

5.  Secondary:   Proportion of Subjects Who Have Undetectable HCV RNA at Week 12   [ Time Frame: Week 12 ]

6.  Secondary:   Proportion of Subjects Who Have Undetectable HCV RNA at the End of Treatment (EOT)   [ Time Frame: Week 24 or Week 48, depending on planned treatment duration ]

7.  Secondary:   Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment (SVR12Planned)   [ Time Frame: 12 weeks after last planned dose of study treatment ]

8.  Secondary:   Proportion of Subjects Who Have Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment (SVR24Actual)   [ Time Frame: 24 weeks after last actual dose of study treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Proportion of Subjects Who Relapse, Defined as Those Who Complete Treatment as Assigned, Have Undetectable HCV RNA at EOT, and Become HCV RNA Detectable During Antiviral Follow-up   [ Time Frame: Week 72 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Proportion of Subjects Who Relapse, Defined as Those Who Have Undetectable HCV RNA at the EOT, and Become HCV RNA Detectable During Antiviral Follow-up   [ Time Frame: Week 72 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Biochemical Response Including Transaminase Levels   [ Time Frame: Week 72 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Noninvasive Markers of Fibrosis   [ Time Frame: Week 72 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Total Fatigue Score From the Fatigue Severity Scale (FSS)   [ Time Frame: Week 72 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

14.  Secondary:   Adverse Events, Physical Examination Findings, and Clinical Laboratory, Vital Sign, and Electrocardiogram (ECG) Assessments   [ Time Frame: Week 72 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame AEs and SAEs During Dosing From Baseline to Week 48
Additional Description No text entered.

Reporting Groups
  Description
Placebo12/PR48 Placebo matching telaprevir in combination with peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin
T8/Placebo4/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus peginterferon alfa-2a and ribavirin, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
T12/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.

Serious Adverse Events
    Placebo12/PR48     T8/Placebo4/PR24or48     T12/PR24or48  
Total, serious adverse events        
# participants affected / at risk     24/361 (6.65%)     31/364 (8.52%)     33/363 (9.09%)  
Blood and lymphatic system disorders        
anemia        
# participants affected / at risk     4/361 (1.11%)     10/364 (2.75%)     8/363 (2.20%)  
# events     361     364     363  
neutropenia        
# participants affected / at risk     1/361 (0.28%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
anemia haemolytic        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
leukopenia        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
pancytopenia        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
thrombocytopenia        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
Cardiac disorders        
atrial fibrillation        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
angina pectoris        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
palpitations        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
Congenital, familial and genetic disorders        
urachal abnormality        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
Eye disorders        
retinal exudates        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
retinal haemorrhage        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
vision blurred        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
Gastrointestinal disorders        
abdominal pain        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
anal fistula        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
colitis ischaemic        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
diarrhoea        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
diverticular perforation        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
inguinal hernia        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
internal hernia        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
intestinal ischaemia        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
pancreatitis        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
pancreatitis acute        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
salivary gland calculus        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
General disorders        
chest pain        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
non-cardiac chest pain        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361         363  
Hepatobiliary disorders        
cholecystitis        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
cholelithiasis        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
hepatic cirrhosis        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
hepatitis acute        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
Immune system disorders        
cryoglobulinaemia        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
Infections and infestations        
Cellulitis        
# participants affected / at risk     1/361 (0.28%)     1/364 (0.27%)     1/363 (0.28%)  
# events     361     364     363  
pneumonia        
# participants affected / at risk     0/361 (0.00%)     2/364 (0.55%)     1/363 (0.28%)  
# events     361     364     363  
appendicitis        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
lobar pneumonia        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     1/363 (0.28%)  
# events     361     364     363  
pyelonephritis        
# participants affected / at risk     1/361 (0.28%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
urinary tract infection        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     2/363 (0.55%)  
# events     361     364     363  
abscess        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
abscess limb        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
acute sinusitis        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
bacteraemia        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
cellulitis staphylococcal        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
escherichia bacteraemia        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
gastroenteritis        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
gastroenteritis viral        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
lung abscess        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
lymphangitis        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
perirectal abscess        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
respiratory tract infection        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
staphylococcal abscess        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
staphylococcal infection        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
subcutaneous abscess        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
tuberculosis        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
Injury, poisoning and procedural complications        
thermal burn        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
Metabolism and nutrition disorders        
dehydration        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
hyponatraemia        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
Musculoskeletal and connective tissue disorders        
back pain        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
costochondritis        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
intervertebral disc        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
pain in extremity        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
rheumatoid arthritis        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
Nervous system disorders        
syncope        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     3/363 (0.83%)  
# events     361     364     363  
convulsion        
# participants affected / at risk     2/361 (0.55%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
migraine        
# participants affected / at risk     1/361 (0.28%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
altered state of consciousness        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
global amnesia        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
Psychiatric disorders        
anxiety        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
completed suicide        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
depression        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
insomnia        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
panic attack        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
psychotic disorder        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
Renal and urinary disorders        
renal failure acute        
# participants affected / at risk     2/361 (0.55%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
nephrolithiasis        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
urinary retention        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
Reproductive system and breast disorders        
metrorrhagia        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
Respiratory, thoracic and mediastinal disorders        
dyspnoea        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
Skin and subcutaneous tissue disorders        
rash        
# participants affected / at risk     0/361 (0.00%)     3/364 (0.82%)     2/363 (0.55%)  
# events     361     364     363  
pruritus        
# participants affected / at risk     1/361 (0.28%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364      
eczema        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
leukocytoclastic vasculitis        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  
rash maculo-papular        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
stevens-johnson syndrome        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
Vascular disorders        
hypotension        
# participants affected / at risk     0/361 (0.00%)     1/364 (0.27%)     0/363 (0.00%)  
# events     361     364     363  
phlebitis        
# participants affected / at risk     0/361 (0.00%)     0/364 (0.00%)     1/363 (0.28%)  
# events     361     364     363  
thrombophlebitis        
# participants affected / at risk     1/361 (0.28%)     0/364 (0.00%)     0/363 (0.00%)  
# events     361     364     363  




  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information