A Safety and Effectiveness Study of Telaprevir in Chronic... | NCT00703118 | Trialant
NCT00703118
Sponsor
Tibotec BVBA
Status
Completed
Last Update Posted
Jan 22, 2014Estimated
Enrollment
663Actual
Phase
Phase 3
Conditions
Hepatitis C, Chronic
Interventions
Telaprevir
Peg-IFN-alfa-2a
Ribavirin
Placebo
Countries
United States
Australia
Austria
Belgium
Brazil
Canada
France
Germany
Israel
Netherlands
Poland
Puerto Rico
Spain
Sweden
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00703118
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR014842
Secondary IDs
ID
Type
Description
Link
VX-950-TIDP24-C216
Other Identifier
Tibotec-Virco Virology BVBA
Brief Title
A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment
Acronym
Not provided
Organization
Tibotec BVBAINDUSTRY
Status Module
Record Verification Date
Dec 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2008
Primary Completion Date
Jul 2010Actual
Completion Date
Jul 2010Actual
First Submitted Date
Jun 19, 2008
First Submission Date that Met QC Criteria
Jun 19, 2008
First Posted Date
Jun 23, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 18, 2011
Results First Submitted that Met QC Criteria
Jul 18, 2011
Results First Posted Date
Aug 11, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 5, 2013
Last Update Posted Date
Jan 22, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Tibotec BVBAINDUSTRY
Collaborators
Name
Class
Tibotec Pharmaceutical Limited
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.
Detailed Description
This is a randomized, double-blind, placebo-controlled Phase III trial with telaprevir in patients with chronic Hepatitis C Virus (HCV), genotype 1, infection who failed prior treatment with standard treatment. Standard treatment is defined as treatment with Peg-INF and RBV. The trial is designed to compare the efficacy, safety, and tolerability of 2 regimens of telaprevir (with and without delayed start) combined with standard treatment versus standard treatment alone. The trial will consist of a screening period of approximately 4 weeks, a 48-week treatment period, and a 24-week follow-up period. Patients will be eligible to enroll in the trial if they (1) had an undetectable HCV Ribonucleic Acid (RNA) level at the end of a prior course of standard treatment but did not achieve a response (viral relapsers), or (2) never had an undetectable HCV RNA level during or at the end of a prior course of standard treatment (non-responders). Approximately 650 patients (350 prior relapsers and 300 prior non-responders) will be randomized in a 2:2:1 ratio to one of 3 treatment groups: Treatment group A will receive telaprevir with standard treatment for 12 weeks; followed by placebo with standard treatment for 4 weeks; followed by standard treatment for 32 weeks. Treatment group B will receive placebo with standard treatment for 4 weeks; followed by telaprevir with standard treatment for 12 weeks; followed by standard treatment for 32 weeks. Treatment group C will receive placebo with standard treatment for 16 weeks; followed by standard treatment for 32 weeks. In both telaprevir regimens (A and B), patients will receive 12 weeks of 750 mg of telaprevir every 8 hours along with 48 weeks of standard treatment. Telaprevir or placebo will be given by mouth at a dose of 750 mg every 8 hours for 16 weeks. Peg-INF will be given as an injection under the skin at a dose of 180 mcg once every week for 48 weeks. RBV will be given by mouth at a dose of either 1000 or 1200 mg (depending on your body weight) two times per day for 48 weeks.
Conditions Module
Conditions
Hepatitis C, Chronic
Keywords
Hepatitis C, Chronic
Telaprevir
Peg-IFN-alfa-2a
Ribavirin
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
663Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group A: T12/PR48
Experimental
Participants will receive 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.
Drug: Telaprevir
Drug: Peg-IFN-alfa-2a
Drug: Ribavirin
Drug: Placebo
Group B: T12(DS)/PR48
Experimental
Participants will receive 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.
Drug: Telaprevir
Drug: Peg-IFN-alfa-2a
Drug: Ribavirin
Drug: Placebo
Group C: Pbo/PR48
Experimental
Participants will receive placebo in combination with Peg- IFN-alfa-2a and ribavirin for 16 weeks. Participants will receive Peg- IFN-alfa-2a and ribavirin for next 32 weeks.
Drug: Peg-IFN-alfa-2a
Drug: Ribavirin
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Telaprevir
Drug
Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B.
Group A: T12/PR48
Group B: T12(DS)/PR48
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned
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.
Week 72
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4
RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.
Week 4
Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level >= 1000 IU/mL
Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)
Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Exclusion Criteria:
Patient is a previous non-responder that is classified as a viral breakthrough case
Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype
Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype
Evidence of decompensated liver disease
Patient has condition that requires use of systemic corticosteroids
Zeuzem S, DeMasi R, Baldini A, Coate B, Luo D, Mrus J, Witek J. Risk factors predictive of anemia development during telaprevir plus peginterferon/ribavirin therapy in treatment-experienced patients. J Hepatol. 2014 Jun;60(6):1112-7. doi: 10.1016/j.jhep.2014.01.013. Epub 2014 Jan 29.
Younossi Z, Negro F, Serfaty L, Pol S, Diago M, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Focaccia R, Foster GR, Horban A, Lonjon-Domanec I, Coate B, DeMasi R, Picchio G, Witek J. Homeostasis model assessment of insulin resistance does not seem to predict response to telaprevir in chronic hepatitis C in the REALIZE trial. Hepatology. 2013 Dec;58(6):1897-906. doi: 10.1002/hep.26437. Epub 2013 Oct 17.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
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.
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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
Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.
Group A: T12/PR48
Group B: T12(DS)/PR48
Group C: Pbo/PR48
Ribavirin
Drug
Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.
Group A: T12/PR48
Group B: T12(DS)/PR48
Group C: Pbo/PR48
Placebo
Drug
Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.
Group A: T12/PR48
Group B: T12(DS)/PR48
Group C: Pbo/PR48
Week 48
Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned
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).
Week 60
Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8
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.
Week 4, Week 6, or Week 8
Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)
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).
Up to Week 72
Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4
Baseline (Day 1) to Week 4
Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12
Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.
Pol S, Aerssens J, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Younossi Z, Foster GR, Focaccia R, Horban A, Pockros PJ, Van Heeswijk RP, De Meyer S, Luo D, Botfield M, Beumont M, Picchio G. Limited impact of IL28B genotype on response rates in telaprevir-treated patients with prior treatment failure. J Hepatol. 2013 May;58(5):883-9. doi: 10.1016/j.jhep.2012.12.023. Epub 2013 Jan 12.
Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.
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
FG002
Pbo/PR48
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
FG000266 subjects
FG001264 subjects
FG002132 subjects
COMPLETED
FG000245 subjects
FG001248 subjects
FG002110 subjects
NOT COMPLETED
FG00021 subjects
FG00116 subjects
FG00222 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0012 subjects
FG0022 subjects
Subject Ineligible To Continue The Trial
FG0006 subjects
FG0013 subjects
FG0022 subjects
Lost to Follow-up
FG0006 subjects
FG0014 subjects
FG0024 subjects
Withdrawal by Subject
FG0008 subjects
FG0017 subjects
FG00213 subjects
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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
BG001
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
BG002
Pbo/PR48
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000266
BG001264
BG002132
BG003662
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00050.7± 8.51
BG00151± 8.24
BG00249.9± 9.74
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00083
BG00175
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0006
BG0012
BG002
AgeCategoricalOther
Number
participants
Title
Denominators
Categories
>= 45 years
Title
Measurements
BG00064
BG00155
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned
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.
Full Analysis Set: All randomized participants who received at least one dose of study medication.
Posted
Number
Participants
Week 72
ID
Title
Description
OG000
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
OG001
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
OG002
Pbo/PR48
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Units
Counts
Participants
OG000266
OG001264
OG002132
Title
Denominators
Categories
Title
Measurements
OG000171
OG001175
OG00222
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
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.
Regression, Logistic
Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate
<0.001
Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure
Difference in percentage of response
46.8
2-Sided
95
36.8
56.7
Secondary
Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4
RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.
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.
Posted
Number
Participants
Week 4
ID
Title
Description
OG000
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
OG001
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
OG002
Pbo/PR48
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Units
Counts
Participants
Secondary
Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)
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.
Posted
Number
Participants
Week 48
ID
Title
Description
OG000
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
OG001
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
OG002
Pbo/PR48
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Units
Counts
Participants
Secondary
Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned
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).
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.
Posted
Number
Participants
Week 60
ID
Title
Description
OG000
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
OG001
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
OG002
Pbo/PR48
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Secondary
Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8
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.
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.
Posted
Number
Participants
Week 4, Week 6, or Week 8
ID
Title
Description
OG000
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
OG001
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
Units
Counts
Participants
OG000
Secondary
Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)
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).
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.
Posted
Number
Participants
Up to Week 72
ID
Title
Description
OG000
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
OG001
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
OG002
Pbo/PR48
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Units
Counts
Secondary
Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4
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.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline (Day 1) to Week 4
ID
Title
Description
OG000
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
OG001
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
OG002
Pbo/PR48
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Units
Counts
Participants
Secondary
Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12
Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.
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.
Posted
Number
Participants
Week 4 and Week 12
ID
Title
Description
OG000
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
OG001
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
OG002
Pbo/PR48
48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Units
Counts
Time Frame
72 weeks
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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
18
266
253
266
EG001
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
17
264
255
264
EG002
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
4
132
126
132
EG003
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
33
266
257
266
EG004
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
32
264
260
264
EG005
Pbo/PR48 - OVERALL TREATMENT
48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the overall treatment phase
7
132
126
132
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0004 affected266 at risk
EG0015 affected264 at risk
EG0021 affected132 at risk
EG0036 affected266 at risk
EG0047 affected264 at risk
EG0051 affected132 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Cardiac valve disease
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Sudden hearing loss
Ear and labyrinth disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Basedow's disease
Endocrine disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0021 affected132 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Caecitis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
General physical health deterioration
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Injection site reaction
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0011 affected264 at risk
EG0020 affected132 at risk
EG003
Pyrexia
General disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Helicobacter gastritis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0011 affected264 at risk
EG0020 affected132 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0021 affected132 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Sepsis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Animal scratch
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0011 affected264 at risk
EG0020 affected132 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Multiple drug overdose
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0011 affected264 at risk
EG0020 affected132 at risk
EG003
Blood corticotrophin decreased
Investigations
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Weight decreased
Investigations
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Bronchial carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0012 affected264 at risk
EG0020 affected132 at risk
EG003
Hepatic neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Histiocytosis haematophagic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Cerebral thrombosis
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Coma
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0021 affected132 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0011 affected264 at risk
EG0020 affected132 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Syncope
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0011 affected264 at risk
EG0020 affected132 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Depression
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0011 affected264 at risk
EG0020 affected132 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0011 affected264 at risk
EG0020 affected132 at risk
EG003
Substance abuse
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0011 affected264 at risk
EG0020 affected132 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Urinary bladder polyp
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Pustular psoriasis
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0011 affected264 at risk
EG0020 affected132 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0011 affected264 at risk
EG0020 affected132 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0012 affected264 at risk
EG0020 affected132 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Peripheral artery aneurysm
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected266 at risk
EG0010 affected264 at risk
EG0020 affected132 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG00070 affected266 at risk
EG00182 affected264 at risk
EG00217 affected132 at risk
EG00378 affected266 at risk
EG00493 affected264 at risk
EG00519 affected132 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG00023 affected266 at risk
EG00113 affected264 at risk
EG0029 affected132 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG00017 affected266 at risk
EG00124 affected264 at risk
EG00212 affected132 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0007 affected266 at risk
EG00114 affected264 at risk
EG0026 affected132 at risk
EG003
Vision blurred
Eye disorders
MedDRA 11.0
Systematic Assessment
EG00010 affected266 at risk
EG0017 affected264 at risk
EG0022 affected132 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00032 affected266 at risk
EG00129 affected264 at risk
EG00216 affected132 at risk
EG003
Anal pruritus
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00014 affected266 at risk
EG00115 affected264 at risk
EG0020 affected132 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00020 affected266 at risk
EG00111 affected264 at risk
EG0020 affected132 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00011 affected266 at risk
EG00111 affected264 at risk
EG0025 affected132 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00060 affected266 at risk
EG00164 affected264 at risk
EG00216 affected132 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00023 affected266 at risk
EG00120 affected264 at risk
EG00212 affected132 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00013 affected266 at risk
EG00115 affected264 at risk
EG00210 affected132 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00038 affected266 at risk
EG00128 affected264 at risk
EG0027 affected132 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00089 affected266 at risk
EG00180 affected264 at risk
EG00231 affected132 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00029 affected266 at risk
EG00128 affected264 at risk
EG00210 affected132 at risk
EG003
Asthenia
General disorders
MedDRA 11.0
Systematic Assessment
EG00049 affected266 at risk
EG00155 affected264 at risk
EG00235 affected132 at risk
EG003
Chills
General disorders
MedDRA 11.0
Systematic Assessment
EG00041 affected266 at risk
EG00131 affected264 at risk
EG00219 affected132 at risk
EG003
Fatigue
General disorders
MedDRA 11.0
Systematic Assessment
EG000138 affected266 at risk
EG001124 affected264 at risk
EG00251 affected132 at risk
EG003
Influenza like illness
General disorders
MedDRA 11.0
Systematic Assessment
EG00085 affected266 at risk
EG00190 affected264 at risk
EG00233 affected132 at risk
EG003
Injection site erythema
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG00014 affected266 at risk
EG00119 affected264 at risk
EG0025 affected132 at risk
EG003
Irritability
General disorders
MedDRA 11.0
Systematic Assessment
EG00031 affected266 at risk
EG00136 affected264 at risk
EG00219 affected132 at risk
EG003
Pain
General disorders
MedDRA 11.0
Systematic Assessment
EG00014 affected266 at risk
EG0015 affected264 at risk
EG0023 affected132 at risk
EG003
Pyrexia
General disorders
MedDRA 11.0
Systematic Assessment
EG00057 affected266 at risk
EG00163 affected264 at risk
EG00232 affected132 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0006 affected266 at risk
EG00110 affected264 at risk
EG0027 affected132 at risk
EG003
Weight decreased
Investigations
MedDRA 11.0
Systematic Assessment
EG0007 affected266 at risk
EG0015 affected264 at risk
EG0026 affected132 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG00032 affected266 at risk
EG00133 affected264 at risk
EG00219 affected132 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG00016 affected266 at risk
EG00119 affected264 at risk
EG0027 affected132 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG00028 affected266 at risk
EG00127 affected264 at risk
EG00219 affected132 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG00014 affected266 at risk
EG00114 affected264 at risk
EG0028 affected132 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG00010 affected266 at risk
EG0016 affected264 at risk
EG0024 affected132 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG00035 affected266 at risk
EG00140 affected264 at risk
EG00224 affected132 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0009 affected266 at risk
EG0017 affected264 at risk
EG0022 affected132 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0005 affected266 at risk
EG00113 affected264 at risk
EG0028 affected132 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG00018 affected266 at risk
EG00123 affected264 at risk
EG0025 affected132 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG00032 affected266 at risk
EG00127 affected264 at risk
EG0028 affected132 at risk
EG003
Headache
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG000106 affected266 at risk
EG001101 affected264 at risk
EG00246 affected132 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0006 affected266 at risk
EG00121 affected264 at risk
EG00211 affected132 at risk
EG003
Depression
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG00020 affected266 at risk
EG00133 affected264 at risk
EG00214 affected132 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG00055 affected266 at risk
EG00170 affected264 at risk
EG00229 affected132 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG00010 affected266 at risk
EG0018 affected264 at risk
EG0027 affected132 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG00044 affected266 at risk
EG00149 affected264 at risk
EG00223 affected132 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG00027 affected266 at risk
EG00141 affected264 at risk
EG00216 affected132 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG00011 affected266 at risk
EG00117 affected264 at risk
EG0025 affected132 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG00012 affected266 at risk
EG00112 affected264 at risk
EG0025 affected132 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG00022 affected266 at risk
EG00119 affected264 at risk
EG00212 affected132 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG00036 affected266 at risk
EG00145 affected264 at risk
EG00221 affected132 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG00019 affected266 at risk
EG00115 affected264 at risk
EG0025 affected132 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0003 affected266 at risk
EG0019 affected264 at risk
EG0026 affected132 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG000132 affected266 at risk
EG001130 affected264 at risk
EG00235 affected132 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG00091 affected266 at risk
EG00188 affected264 at risk
EG00224 affected132 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Leader
Tibotec
1 609 730-3174
ID
Term
D019698
Hepatitis C, Chronic
Ancestor Terms
ID
Term
D006526
Hepatitis C
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D006525
Hepatitis, Viral, Human
D014777
Virus Diseases
D018178
Flaviviridae Infections
D012327
RNA Virus Infections
D006521
Hepatitis, Chronic
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C486464
telaprevir
C100416
peginterferon alfa-2a
D012254
Ribavirin
Ancestor Terms
ID
Term
D012263
Ribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
50.6
± 8.66
44
BG003202
Male
BG000183
BG001189
BG00288
BG003460
3
BG00311
Black or African American
Title
Measurements
BG00011
BG0018
BG00211
BG00330
White
Title
Measurements
BG000246
BG001252
BG002117
BG003615
Other
Title
Measurements
BG0003
BG0012
BG0021
BG0036
40
BG003159
Between 45 and 65 years
Title
Measurements
BG000197
BG001201
BG00285
BG003483
>= 65 years
Title
Measurements
BG0005
BG0018
BG0027
BG00320
Difference in percentage of response was estimated through the logistic regression model.
No
Superiority or Other
OG001
OG002
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.
Regression, Logistic
Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate
<0.001
Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure
Difference in percentage of response
49.8
2-Sided
95
39.9
59.7
Difference in percentage of response was estimated through the logistic regression model.