Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 58 of 540 for:    IFNA2 AND RBV AND IFN alfa-2

An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants

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: NCT00528528
Recruitment Status : Completed
First Posted : September 12, 2007
Results First Posted : May 1, 2013
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Tibotec BVBA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: Telaprevir
Drug: Peg-IFN-alfa-2a
Drug: Peg-IFN-alfa-2b
Drug: Ribavirin (RBV) tablet
Drug: Ribavirin (RBV) capsule
Enrollment 166
Recruitment Details  
Pre-assignment Details Out of 166 participants who were randomly assigned to treatment, only 161 participants received the study treatment.
Arm/Group Title Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Hide Arm/Group Description Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of 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 up to 48 weeks. Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Period Title: Overall Study
Started 40 42 40 39
Ongoing at Time of Cut-off 0 0 1 0
Completed 37 39 37 36
Not Completed 3 3 3 3
Reason Not Completed
Lost to Follow-up             0             0             1             1
Ineligible to continue the trial             0             0             0             1
Other             0             1             0             0
Withdrawal by Subject             3             2             1             1
Ongoing participant             0             0             1             0
Arm/Group Title Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule Total
Hide Arm/Group Description Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of 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 up to 48 weeks. Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 40 42 40 39 161
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 42 participants 40 participants 39 participants 161 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
 100.0%
41
  97.6%
40
 100.0%
39
 100.0%
160
  99.4%
>=65 years
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
1
   0.6%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 40 participants 42 participants 40 participants 39 participants 161 participants
46.5
(39.5 to 51)
45.5
(41 to 51)
40
(34 to 47.5)
49
(43 to 54)
46
(37 to 51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 42 participants 40 participants 39 participants 161 participants
Female
20
  50.0%
22
  52.4%
19
  47.5%
20
  51.3%
81
  50.3%
Male
20
  50.0%
20
  47.6%
21
  52.5%
19
  48.7%
80
  49.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 42 participants 40 participants 39 participants 161 participants
Austria 1 1 1 3 6
Belgium 6 5 8 4 23
France 13 17 12 13 55
Germany 13 11 11 11 46
Italy 1 3 2 3 9
Netherland 1 1 2 1 5
Spain 5 4 4 4 17
1.Primary Outcome
Title Percentage of Participants With Virologic Response at Week 12
Hide Description Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants’ plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants’ plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).
Time Frame End of treatment (EOT) (up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of the study medication.
Arm/Group Title Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Hide Arm/Group Description:
Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of 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 up to 48 weeks.
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Overall Number of Participants Analyzed 40 42 40 39
Measure Type: Number
Unit of Measure: Percentage of participants
92.5 88.1 92.5 87.2
2.Secondary Outcome
Title Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
Hide Description Virologic response was either defined as having undetectable HCV RNA (i.e., no HCV RNA was detected in the participants’ plasma samples) or less than 25 IU/mL HCV RNA (i.e., the participants’ plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).
Time Frame Baseline (Day 1) up to EOT (up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants who received at least 1 dose of the study medication.
Arm/Group Title Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Hide Arm/Group Description:
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Overall Number of Participants Analyzed 40 42 40 39
Median (Full Range)
Unit of Measure: Days
22
(8 to 99)
22.5
(8 to 99)
22
(2 to 99)
29
(2 to 169)
3.Secondary Outcome
Title Number of Participants With Viral Breakthrough at End of Treatment (EOT)
Hide Description Viral breakthrough was defined as a confirmed increase of more than 1 log 10 in HCV RNA level from the lowest level reached or a confirmed value of HCV RNA more than 100 IU/mL in participants whose HCV RNA was previously less than 25 IU/mL.
Time Frame EOT (up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants who received at least 1 dose of the study medication.
Arm/Group Title Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Hide Arm/Group Description:
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Overall Number of Participants Analyzed 40 42 40 39
Measure Type: Number
Unit of Measure: Participants
1 6 3 4
4.Secondary Outcome
Title Percentage of Participants With Partial Response
Hide Description Partial response was defined as having at least 2 log drop in HCV RNA from Baseline, but not having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants’ plasma samples).
Time Frame Baseline (Day 1) up to EOT (up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants who received at least 1 dose of the study medication.
Arm/Group Title Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Hide Arm/Group Description:
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Overall Number of Participants Analyzed 40 42 40 39
Measure Type: Number
Unit of Measure: Percentage of participants
5 0 2.5 5.1
5.Secondary Outcome
Title Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12
Hide Description Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. HCV RNA samples were taken pre-dose of Peg-IFN administration.
Time Frame Baseline (pre-dose), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants who received at least 1 dose of the study medication.
Arm/Group Title Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Hide Arm/Group Description:
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Overall Number of Participants Analyzed 40 42 40 39
Mean (Standard Error)
Unit of Measure: log 10 IU/mL
Baseline 6.4  (0.09) 6.5  (0.10) 6.4  (0.09) 6.5  (0.11)
Change from Baseline at Week 12 -5.2  (0.24) -5.4  (0.23) -4.8  (0.36) -5.1  (0.29)
6.Secondary Outcome
Title Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT)
Hide Description Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology.
Time Frame Baseline (pre-dose), EOT (up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants who received at least 1 dose of the study medication.
Arm/Group Title Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Hide Arm/Group Description:
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Overall Number of Participants Analyzed 40 42 40 39
Mean (Standard Error)
Unit of Measure: log 10 IU/mL
-5.5  (0.14) -5.2  (0.25) -5.4  (0.22) -5.3  (0.23)
7.Secondary Outcome
Title Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24)
Hide Description SVR24 was defined as having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants’ plasma samples) at EOT and no confirmed detectable HCV RNA levels between EOT and 24 weeks after the last dose of study medication.
Time Frame EOT (up to Week 48) and up to 24 weeks after EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants who received at least 1 dose of the study medication.
Arm/Group Title Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Hide Arm/Group Description:
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Overall Number of Participants Analyzed 40 42 40 39
Measure Type: Number
Unit of Measure: Percentage of participants
85.0 81.0 82.5 82.1
Time Frame Baseline up to end of telaprevir treatment (Week 12)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Hide Arm/Group Description Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of 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 up to 48 weeks. Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
All-Cause Mortality
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/40 (12.50%)   1/42 (2.38%)   4/40 (10.00%)   1/39 (2.56%) 
Blood and lymphatic system disorders         
Anaemia * 1  4/40 (10.00%)  0/42 (0.00%)  0/40 (0.00%)  0/39 (0.00%) 
General disorders         
Hyperthermia * 1  0/40 (0.00%)  0/42 (0.00%)  1/40 (2.50%)  0/39 (0.00%) 
Nervous system disorders         
Headache * 1  0/40 (0.00%)  1/42 (2.38%)  0/40 (0.00%)  0/39 (0.00%) 
Renal and urinary disorders         
Renal failure * 1  0/40 (0.00%)  0/42 (0.00%)  1/40 (2.50%)  0/39 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumonitis * 1  0/40 (0.00%)  0/42 (0.00%)  0/40 (0.00%)  1/39 (2.56%) 
Pneumothorax * 1  0/40 (0.00%)  0/42 (0.00%)  1/40 (2.50%)  0/39 (0.00%) 
Skin and subcutaneous tissue disorders         
Pruritus * 1  1/40 (2.50%)  0/42 (0.00%)  0/40 (0.00%)  0/39 (0.00%) 
Toxic skin eruption * 1  1/40 (2.50%)  0/42 (0.00%)  0/40 (0.00%)  0/39 (0.00%) 
Rash * 1  0/40 (0.00%)  0/42 (0.00%)  3/40 (7.50%)  0/39 (0.00%) 
Vascular disorders         
Thrombophlebitis * 1  0/40 (0.00%)  0/42 (0.00%)  1/40 (2.50%)  0/39 (0.00%) 
*
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%
Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   40/40 (100.00%)   41/42 (97.62%)   39/40 (97.50%)   39/39 (100.00%) 
Blood and lymphatic system disorders         
Anaemia * 1  17/40 (42.50%)  14/42 (33.33%)  14/40 (35.00%)  20/39 (51.28%) 
Leukopenia * 1  6/40 (15.00%)  8/42 (19.05%)  8/40 (20.00%)  9/39 (23.08%) 
Lymphopenia * 1  3/40 (7.50%)  6/42 (14.29%)  2/40 (5.00%)  3/39 (7.69%) 
Neutropenia * 1  2/40 (5.00%)  2/42 (4.76%)  0/40 (0.00%)  1/39 (2.56%) 
Thrombocytopenia * 1  2/40 (5.00%)  1/42 (2.38%)  2/40 (5.00%)  1/39 (2.56%) 
Cardiac disorders         
Tachycardia * 1  2/40 (5.00%)  3/42 (7.14%)  3/40 (7.50%)  2/39 (5.13%) 
Palpitations * 1  1/40 (2.50%)  2/42 (4.76%)  1/40 (2.50%)  3/39 (7.69%) 
Ear and labyrinth disorders         
Vertigo * 1  1/40 (2.50%)  2/42 (4.76%)  1/40 (2.50%)  4/39 (10.26%) 
Tinnitus * 1  0/40 (0.00%)  0/42 (0.00%)  1/40 (2.50%)  2/39 (5.13%) 
Eye disorders         
Dry eye * 1  3/40 (7.50%)  0/42 (0.00%)  1/40 (2.50%)  2/39 (5.13%) 
Vision blurred * 1  1/40 (2.50%)  1/42 (2.38%)  0/40 (0.00%)  3/39 (7.69%) 
Gastrointestinal disorders         
Nausea * 1  18/40 (45.00%)  14/42 (33.33%)  16/40 (40.00%)  23/39 (58.97%) 
Diarrhoea * 1  10/40 (25.00%)  9/42 (21.43%)  12/40 (30.00%)  13/39 (33.33%) 
Vomiting * 1  7/40 (17.50%)  5/42 (11.90%)  7/40 (17.50%)  12/39 (30.77%) 
Abdominal pain upper * 1  5/40 (12.50%)  5/42 (11.90%)  3/40 (7.50%)  5/39 (12.82%) 
Dry mouth * 1  5/40 (12.50%)  5/42 (11.90%)  6/40 (15.00%)  9/39 (23.08%) 
Dyspepsia * 1  5/40 (12.50%)  3/42 (7.14%)  3/40 (7.50%)  8/39 (20.51%) 
Haemorrhoids * 1  4/40 (10.00%)  5/42 (11.90%)  1/40 (2.50%)  3/39 (7.69%) 
Anal discomfort * 1  3/40 (7.50%)  3/42 (7.14%)  1/40 (2.50%)  3/39 (7.69%) 
Pruritus ani * 1  3/40 (7.50%)  8/42 (19.05%)  3/40 (7.50%)  4/39 (10.26%) 
Constipation * 1  2/40 (5.00%)  1/42 (2.38%)  1/40 (2.50%)  3/39 (7.69%) 
Abdominal pain * 1  1/40 (2.50%)  4/42 (9.52%)  0/40 (0.00%)  3/39 (7.69%) 
Aphthous stomatitis * 1  0/40 (0.00%)  1/42 (2.38%)  1/40 (2.50%)  2/39 (5.13%) 
Gastric disorder * 1  0/40 (0.00%)  0/42 (0.00%)  2/40 (5.00%)  0/39 (0.00%) 
General disorders         
Fatigue * 1  15/40 (37.50%)  15/42 (35.71%)  16/40 (40.00%)  15/39 (38.46%) 
Influenza like illness * 1  15/40 (37.50%)  19/42 (45.24%)  11/40 (27.50%)  20/39 (51.28%) 
Asthenia * 1  12/40 (30.00%)  16/42 (38.10%)  8/40 (20.00%)  14/39 (35.90%) 
Pyrexia * 1  8/40 (20.00%)  14/42 (33.33%)  8/40 (20.00%)  11/39 (28.21%) 
Chills * 1  3/40 (7.50%)  3/42 (7.14%)  5/40 (12.50%)  4/39 (10.26%) 
Injection site erythema * 1  3/40 (7.50%)  6/42 (14.29%)  7/40 (17.50%)  7/39 (17.95%) 
Feeling cold * 1  2/40 (5.00%)  0/42 (0.00%)  0/40 (0.00%)  1/39 (2.56%) 
Injection site reaction * 1  1/40 (2.50%)  2/42 (4.76%)  0/40 (0.00%)  2/39 (5.13%) 
Irritability * 1  1/40 (2.50%)  3/42 (7.14%)  1/40 (2.50%)  1/39 (2.56%) 
Chest discomfort * 1  0/40 (0.00%)  0/42 (0.00%)  2/40 (5.00%)  0/39 (0.00%) 
Infections and infestations         
Nasopharyngitis * 1  3/40 (7.50%)  1/42 (2.38%)  0/40 (0.00%)  1/39 (2.56%) 
Urinary tract infection * 1  2/40 (5.00%)  3/42 (7.14%)  1/40 (2.50%)  0/39 (0.00%) 
Investigations         
Weight decreased * 1  4/40 (10.00%)  3/42 (7.14%)  2/40 (5.00%)  2/39 (5.13%) 
Blood uric acid increased * 1  3/40 (7.50%)  3/42 (7.14%)  1/40 (2.50%)  8/39 (20.51%) 
Blood phosphorus decreased * 1  2/40 (5.00%)  1/42 (2.38%)  0/40 (0.00%)  0/39 (0.00%) 
Haemoglobin decreased * 1  1/40 (2.50%)  0/42 (0.00%)  2/40 (5.00%)  3/39 (7.69%) 
Platelet count decreased * 1  1/40 (2.50%)  0/42 (0.00%)  1/40 (2.50%)  2/39 (5.13%) 
Blood bilirubin increased * 1  0/40 (0.00%)  0/42 (0.00%)  2/40 (5.00%)  3/39 (7.69%) 
Prothrombin time prolonged * 1  0/40 (0.00%)  0/42 (0.00%)  2/40 (5.00%)  0/39 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  8/40 (20.00%)  4/42 (9.52%)  6/40 (15.00%)  15/39 (38.46%) 
Anorexia * 1  1/40 (2.50%)  2/42 (4.76%)  1/40 (2.50%)  4/39 (10.26%) 
Hyperuricaemia * 1  0/40 (0.00%)  2/42 (4.76%)  0/40 (0.00%)  3/39 (7.69%) 
Musculoskeletal and connective tissue disorders         
Myalgia * 1  4/40 (10.00%)  5/42 (11.90%)  9/40 (22.50%)  5/39 (12.82%) 
Arthralgia * 1  2/40 (5.00%)  3/42 (7.14%)  5/40 (12.50%)  3/39 (7.69%) 
Back pain * 1  0/40 (0.00%)  2/42 (4.76%)  1/40 (2.50%)  3/39 (7.69%) 
Nervous system disorders         
Headache * 1  13/40 (32.50%)  18/42 (42.86%)  14/40 (35.00%)  16/39 (41.03%) 
Dizziness * 1  4/40 (10.00%)  2/42 (4.76%)  0/40 (0.00%)  6/39 (15.38%) 
Disturbance in attention * 1  2/40 (5.00%)  2/42 (4.76%)  1/40 (2.50%)  6/39 (15.38%) 
Paraesthesia * 1  2/40 (5.00%)  1/42 (2.38%)  0/40 (0.00%)  2/39 (5.13%) 
Dysgeusia * 1  1/40 (2.50%)  2/42 (4.76%)  6/40 (15.00%)  2/39 (5.13%) 
Tremor * 1  0/40 (0.00%)  0/42 (0.00%)  0/40 (0.00%)  2/39 (5.13%) 
Psychiatric disorders         
Insomnia * 1  8/40 (20.00%)  10/42 (23.81%)  7/40 (17.50%)  9/39 (23.08%) 
Depression * 1  6/40 (15.00%)  6/42 (14.29%)  4/40 (10.00%)  6/39 (15.38%) 
Sleep disorder * 1  4/40 (10.00%)  3/42 (7.14%)  4/40 (10.00%)  7/39 (17.95%) 
Nervousness * 1  3/40 (7.50%)  1/42 (2.38%)  3/40 (7.50%)  4/39 (10.26%) 
Anxiety * 1  2/40 (5.00%)  3/42 (7.14%)  3/40 (7.50%)  3/39 (7.69%) 
Depressed mood * 1  2/40 (5.00%)  2/42 (4.76%)  0/40 (0.00%)  1/39 (2.56%) 
Libido decreased * 1  1/40 (2.50%)  1/42 (2.38%)  1/40 (2.50%)  3/39 (7.69%) 
Reproductive system and breast disorders         
Erectile dysfunction * 1  0/40 (0.00%)  0/42 (0.00%)  0/40 (0.00%)  2/39 (5.13%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  8/40 (20.00%)  7/42 (16.67%)  9/40 (22.50%)  5/39 (12.82%) 
Dyspnoea * 1  6/40 (15.00%)  6/42 (14.29%)  9/40 (22.50%)  7/39 (17.95%) 
Dyspnoea exertional * 1  3/40 (7.50%)  7/42 (16.67%)  2/40 (5.00%)  2/39 (5.13%) 
Epistaxis * 1  3/40 (7.50%)  2/42 (4.76%)  2/40 (5.00%)  2/39 (5.13%) 
Dry throat * 1  0/40 (0.00%)  0/42 (0.00%)  0/40 (0.00%)  3/39 (7.69%) 
Pharyngolaryngeal pain * 1  0/40 (0.00%)  2/42 (4.76%)  1/40 (2.50%)  2/39 (5.13%) 
Skin and subcutaneous tissue disorders         
Rash * 1  25/40 (62.50%)  15/42 (35.71%)  15/40 (37.50%)  14/39 (35.90%) 
Pruritus * 1  16/40 (40.00%)  22/42 (52.38%)  19/40 (47.50%)  22/39 (56.41%) 
Dry skin * 1  3/40 (7.50%)  9/42 (21.43%)  6/40 (15.00%)  6/39 (15.38%) 
Erythema * 1  3/40 (7.50%)  3/42 (7.14%)  1/40 (2.50%)  1/39 (2.56%) 
Photosensitivity reaction * 1  2/40 (5.00%)  0/42 (0.00%)  1/40 (2.50%)  0/39 (0.00%) 
Alopecia * 1  0/40 (0.00%)  3/42 (7.14%)  2/40 (5.00%)  9/39 (23.08%) 
Eczema * 1  0/40 (0.00%)  2/42 (4.76%)  1/40 (2.50%)  2/39 (5.13%) 
Skin fissures * 1  0/40 (0.00%)  0/42 (0.00%)  0/40 (0.00%)  2/39 (5.13%) 
*
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.
As per revised Protocol dated 21 Dec 2007, Investigator may not submit for publication or presentation, the results of trial without prior written consent of Sponsor. The Investigator agrees to allow at least 45 days for Sponsor to review prepublication manuscript prior to submission to Publisher. In accordance with generally recognized principles of scientific collaboration, co-authorship with any company personnel will be discussed and mutually agreed upon before submission to Publisher.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Leader
Organization: Janssen Research & Development, LLC Titusville, NJ
Phone: 609-730-3174
Layout table for additonal information
Responsible Party: Tibotec BVBA
ClinicalTrials.gov Identifier: NCT00528528     History of Changes
Obsolete Identifiers: NCT00614497
Other Study ID Numbers: CR013516
VX-950-TIDP24-C208
2007-001044-44 ( EudraCT Number )
First Submitted: September 10, 2007
First Posted: September 12, 2007
Results First Submitted: March 18, 2013
Results First Posted: May 1, 2013
Last Update Posted: June 25, 2014