A Study of TMC435 in Combination With Pegylated Interfero... | NCT00882908 | Trialant
NCT00882908
Sponsor
Tibotec Pharmaceuticals, Ireland
Status
Completed
Last Update Posted
Jun 16, 2014Estimated
Enrollment
386Actual
Phase
Phase 2
Conditions
Hepatitis C
Interventions
TMC435
Ribavirin (R)
PegIFNα-2a (P)
Placebo
Countries
United States
Australia
Austria
Belgium
Canada
Denmark
France
Germany
New Zealand
Norway
Poland
Russia
Spain
Protocol Section
Identification Module
NCT ID
NCT00882908
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR015799
Secondary IDs
ID
Type
Description
Link
TMC435-TiDP16-C205
Other Identifier
Tibotec Pharmaceuticals, Ireland
2008-007147-13
EudraCT Number
Brief Title
A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment
Official Title
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin In Treatment-Naive Genotype 1 Hepatitis C-Infected Subjects
Acronym
PILLAR
Organization
Tibotec Pharmaceuticals, IrelandINDUSTRY
Status Module
Record Verification Date
May 2014
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
Jun 2009
Primary Completion Date
Apr 2010Actual
Completion Date
Apr 2011Actual
First Submitted Date
Apr 16, 2009
First Submission Date that Met QC Criteria
Apr 16, 2009
First Posted Date
Apr 17, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 18, 2013
Results First Submitted that Met QC Criteria
May 19, 2014
Results First Posted Date
Jun 16, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 7, 2011
Certification/Extension First Submitted that Passed QC Review
Jul 7, 2011
Certification/Extension First Posted Date
Jul 14, 2011Estimated
Last Update Submitted Date
May 19, 2014
Last Update Posted Date
Jun 16, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Tibotec Pharmaceuticals, IrelandINDUSTRY
Collaborators
Not provided
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 evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA [less than 25 IU per mL undetectable] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.
Detailed Description
This is a randomized (study medication assigned by chance), 5-arm, double-blind (neither investigator nor the participant knows the treatment that the participant receives), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study) study to compare the efficacy, tolerability and safety of different TMC435 regimens combined with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) versus PegIFNα-2a plus RBV alone in adult treatment-naive patients with chronic genotype 1 HCV infection. The study mainly consists of 3 phases: screening phase (approximately 6 weeks), treatment phase (up to 48 weeks), and follow up phase (up to 48 weeks). In the treatment phase, patients will be divided in to 5 different arms in a 1:1:1:1:1 randomized ratio. In treatment arms 1 and 2, patients will receive 12 weeks of therapy with TMC435 along with PegIFNα 2a and RBV followed by treatment with PegIFNα 2a, RBV, and TMC435-matched placebo. In treatment arms 3 and 4, patients will receive 24 weeks of therapy with TMC435, PegIFNα 2a, and RBV. In treatment arm 5 (control group), patients will receive PegIFNα 2a and RBV for 48 weeks and TMC435 matched placebo for the first 24 weeks. Collection of blood samples for efficacy evaluations will be done at scheduled visits throughout the study. Safety evaluations for adverse events, clinical laboratory tests, physical examination, vital signs and electrocardiogram will be monitored throughout the study. The total duration of the study will be up to approximately 72 weeks after initiation of treatment.
Conditions Module
Conditions
Hepatitis C
Keywords
Hepatitis C
TMC435
Peginterferon alpha-2a
PegIFNalpha-2a
RBV
Ribavirin
Placebo
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
386Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
TMC435 75 mg 12 Wks + PR 24/48
Experimental
Participants will receive TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
Drug: TMC435
Drug: Ribavirin (R)
Drug: PegIFNα-2a (P)
Drug: Placebo
TMC435 75 mg 24 Wks + PR 24/48
Experimental
Participants will receive TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
Drug: TMC435
Drug: Ribavirin (R)
Drug: PegIFNα-2a (P)
Drug: Placebo
TMC435 150 mg 12 Wks + PR 24/48
Experimental
Participants will receive TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
Drug: TMC435
Drug: Ribavirin (R)
Drug: PegIFNα-2a (P)
Drug: Placebo
TMC435 150 mg 24 Wks + PR 24/48
Experimental
Participants will receive TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TMC435
Drug
TMC435 will be administered as one or two 75 mg capsules orally, once daily, for 12 or 24 weeks.
TMC435 150 mg 12 Wks + PR 24/48
TMC435 150 mg 24 Wks + PR 24/48
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)
The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.
Week 72
Secondary Outcomes
Measure
Description
Time Frame
The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-up
The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels of less than 25 IU/mL undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients with documented chronic genotype-1 hepatitis C infection and with plasma HCV RNA of > 100,000 IU/mL at screening
Patients that have not been treated before for HCV
Patients that are of childbearing potential or have a partner of childbearing potential should agree to use 2 effective methods of contraception
Exclusion Criteria:
Patients with cirrhosis or evidence of hepatic decompensation
Co-infection with the human immunodeficiency virus (HIV)
Any contraindication to Pegasys or Copegus therapy
History of, or any current medical condition which could impact the safety of the patient in the study
Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.
In total, 506 participants were screened; 388 participants were randomized of whom 386 participants started treatment. Two randomized participants did not start treatment due to withdrawal of consent.
Recruitment Details
The study was conducted at 79 sites in 13 countries: Australia, New Zealand, Canada, Austria, Belgium, Germany, Spain, France, Poland, Russia, Norway, Denmark, and the United States. Approximately 68% of participants were enrolled in Europe, 21% in North America, and 11% in Australia/New Zealand.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
Participants will receive Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
Drug: Ribavirin (R)
Drug: PegIFNα-2a (P)
Drug: Placebo
TMC435 75 mg 12 Wks + PR 24/48
TMC435 75 mg 24 Wks + PR 24/48
TMC 435
Ribavirin (R)
Drug
Ribavirin (R) will be administered as 200 mg tablets (5 to 6 tablets) orally, twice daily, for 48 weeks.
Placebo 24 Wks + PR48
TMC435 150 mg 12 Wks + PR 24/48
TMC435 150 mg 24 Wks + PR 24/48
TMC435 75 mg 12 Wks + PR 24/48
TMC435 75 mg 24 Wks + PR 24/48
COPEGUS
PegIFNα-2a (P)
Drug
PegIFNα-2a (P) 180 micrograms will be administered as a subcutaneous (under the skin) injection, once weekly for 48 weeks.
Placebo 24 Wks + PR48
TMC435 150 mg 12 Wks + PR 24/48
TMC435 150 mg 24 Wks + PR 24/48
TMC435 75 mg 12 Wks + PR 24/48
TMC435 75 mg 24 Wks + PR 24/48
PEGASYS
Placebo
Drug
Placebo capsules identical in appearance to TMC435 capsule will be administered orally, once daily, for 48 weeks.
Placebo 24 Wks + PR48
TMC435 150 mg 12 Wks + PR 24/48
TMC435 150 mg 24 Wks + PR 24/48
TMC435 75 mg 12 Wks + PR 24/48
TMC435 75 mg 24 Wks + PR 24/48
Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)
The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-up
The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA less than 25 IU/mL detectable or undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).
Weeks 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)
The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During Treatment
The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA greater than or equal to 2 log10 drop from Baseline at selected time points during treatment.
Baseline (Day 1) and Weeks, 2, 4, 8, and 12
The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 24 weeks after the EOT.
Week 48 or 72
The Percentage of Participants Achieving a Rapid Virologic Response (RVR)
The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.
Week 4
The Percentage of Participants Achieving an Early Virologic Response (EVR)
The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.
Baseline (Day 1) and Week 12
The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)
The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.
Week 12
The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
The table below shows the percentage of participants who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the EOT.
Up to Week 36 or 52
Number of Participants With Viral Breakthrough
The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period of the study, defined as a confirmed increase of more than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA more than 100 IU/mL in participants whose plasma HCV RNA level had previously been below the limit of quantification (less than 25 IU/mL detectable or undetectable).
Week 24 or 48
The Number of Participants With Viral Relapse
The table below shows the number of participants who experienced viral relapse, defined as a confirmed detectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.
Up to Week 72
The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)
The table below shows the number of participants with abnormal ALT levels at Baseline who achieved ALT levels within the normal range at the EOT.
Baseline (Day 1) up to Week 24 or 48
Plasma Concentrations of TMC435
The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for participants in each of the 4 TMC435 treatment groups.
Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435
The table below shows the median (range) AUC24h values for TMC435 for participants in each of the 4 TMC435 treatment groups. Two blood samples taken at least 2 hours apart from each other for determination of TMC435 plasma pharmacokinetics were obtained in all participants on Weeks 2, 4, 8, 12, 16, and 24 to obtain Bayesian estimates of TMC435 AUC24h (overall exposure).
Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24
Scott J, Rosa K, Fu M, Cerri K, Peeters M, Beumont M, Zeuzem S, Evon DM, Gilles L. Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection. BMC Infect Dis. 2014 Aug 26;14:465. doi: 10.1186/1471-2334-14-465.
Fried MW, Buti M, Dore GJ, Flisiak R, Ferenci P, Jacobson I, Marcellin P, Manns M, Nikitin I, Poordad F, Sherman M, Zeuzem S, Scott J, Gilles L, Lenz O, Peeters M, Sekar V, De Smedt G, Beumont-Mauviel M. Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naive genotype 1 hepatitis C: the randomized PILLAR study. Hepatology. 2013 Dec;58(6):1918-29. doi: 10.1002/hep.26641. Epub 2013 Oct 11.
FG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
FG002
TMC435 150 mg 12 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
FG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
FG004
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
FG00078 subjects
FG00175 subjects
FG00277 subjects
FG00379 subjects
FG00477 subjects
COMPLETED
FG00075 subjects
FG00169 subjects
FG00270 subjects
FG00372 subjects
FG00471 subjects
NOT COMPLETED
FG0003 subjects
FG0016 subjects
FG0027 subjects
FG0037 subjects
FG0046 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
Lost to Follow-up
FG0003 subjects
FG0015 subjects
FG0023 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0035 subjects
FG004
Subject reached a virologic endpoint
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study terminated in error
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
BG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
BG002
TMC435 150 mg 12 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
BG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
BG004
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00078
BG00175
BG00277
BG00379
BG00477
BG005386
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00047(19 to 66)
BG00146(18 to 67)
BG00247(18 to 69)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00038
BG00128
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Asia Pacific
Title
Measurements
BG0009
BG0019
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
The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)
The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.
The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.
Posted
Number
Percentage of participants
Week 72
ID
Title
Description
OG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG002
TMC435 150 mg 12 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG004
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
Units
Counts
Participants
OG00078
OG00175
OG00277
OG003
Title
Denominators
Categories
Title
Measurements
OG00080.8
OG00170.7
OG00277.9
OG003
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
OG001
OG004
TMC435 75 mg 12 and 24 week treatment groups were pooled and the percentage of participants acheiving SVRW72 were compared with the percentage of participants acheiving SVRW72 in the placebo treatment group.
Regression, Logistic
0.051
Difference in proportions of SVRW72
13.0
2-Sided
97.5
-1.9
28.0
Difference in percentages of participants in the TMC435 75mg and placebo groups with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72 estimated from the logistic regression model.
No
Superiority or Other
Secondary
The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-up
The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels of less than 25 IU/mL undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).
The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.
Posted
Number
Percentage of participants
Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)
ID
Title
Description
OG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
Secondary
The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-up
The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA less than 25 IU/mL detectable or undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).
The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.
Posted
Number
Percentage of participants
Weeks 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)
ID
Title
Description
OG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
Secondary
The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During Treatment
The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA greater than or equal to 2 log10 drop from Baseline at selected time points during treatment.
The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.
Posted
Number
Percentage of participants
Baseline (Day 1) and Weeks, 2, 4, 8, and 12
ID
Title
Description
OG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG002
Secondary
The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 24 weeks after the EOT.
The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.
Posted
Number
Percentage of participants
Week 48 or 72
ID
Title
Description
OG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG002
TMC435 150 mg 12 Wks + PR 24/48
Secondary
The Percentage of Participants Achieving a Rapid Virologic Response (RVR)
The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.
The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.
Posted
Number
Percentage of participants
Week 4
ID
Title
Description
OG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG002
TMC435 150 mg 12 Wks + PR 24/48
Secondary
The Percentage of Participants Achieving an Early Virologic Response (EVR)
The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.
The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.
Posted
Number
Percentage of participants
Baseline (Day 1) and Week 12
ID
Title
Description
OG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG002
TMC435 150 mg 12 Wks + PR 24/48
Secondary
The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)
The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.
The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG002
TMC435 150 mg 12 Wks + PR 24/48
Secondary
The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
The table below shows the percentage of participants who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the EOT.
The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.
Posted
Number
Percentage of participants
Up to Week 36 or 52
ID
Title
Description
OG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG002
TMC435 150 mg 12 Wks + PR 24/48
Secondary
Number of Participants With Viral Breakthrough
The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period of the study, defined as a confirmed increase of more than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA more than 100 IU/mL in participants whose plasma HCV RNA level had previously been below the limit of quantification (less than 25 IU/mL detectable or undetectable).
The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.
Posted
Number
Participants
Week 24 or 48
ID
Title
Description
OG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
Secondary
The Number of Participants With Viral Relapse
The table below shows the number of participants who experienced viral relapse, defined as a confirmed detectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.
The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.
Posted
Number
Participants
Up to Week 72
ID
Title
Description
OG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG002
TMC435 150 mg 12 Wks + PR 24/48
Secondary
The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)
The table below shows the number of participants with abnormal ALT levels at Baseline who achieved ALT levels within the normal range at the EOT.
The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.
Posted
Number
Participants
Baseline (Day 1) up to Week 24 or 48
ID
Title
Description
OG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG002
TMC435 150 mg 12 Wks + PR 24/48
Secondary
Plasma Concentrations of TMC435
The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for participants in each of the 4 TMC435 treatment groups.
Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.
Posted
Median
Full Range
ng/mL
Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24
ID
Title
Description
OG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG002
TMC435 150 mg 12 Wks + PR 24/48
Secondary
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435
The table below shows the median (range) AUC24h values for TMC435 for participants in each of the 4 TMC435 treatment groups. Two blood samples taken at least 2 hours apart from each other for determination of TMC435 plasma pharmacokinetics were obtained in all participants on Weeks 2, 4, 8, 12, 16, and 24 to obtain Bayesian estimates of TMC435 AUC24h (overall exposure).
Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.
Posted
Median
Full Range
ng*h/mL
Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24
ID
Title
Description
OG000
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
Time Frame
72 weeks
Description
All participants who received at least one dose of investigational medication included in safety analysis.
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
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
9
78
76
78
EG001
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
4
75
75
75
EG002
TMC435 150 mg 12 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
4
77
74
77
EG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
3
79
77
79
EG004
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
10
77
75
77
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Incision site cellulitis
Infections and infestations
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG0030 affected79 at risk
EG004
Necrotising fasciitis
Infections and infestations
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Perihepatic abscess
Infections and infestations
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0011 affected75 at risk
EG0020 affected77 at risk
EG003
Appendicitis
Infections and infestations
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Vulval abscess
Infections and infestations
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0021 affected77 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0011 affected75 at risk
EG0020 affected77 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0011 affected75 at risk
EG0020 affected77 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0021 affected77 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0021 affected77 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Spinal disorder
Musculoskeletal and connective tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0021 affected77 at risk
EG003
Parathyroid tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Ovarian neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Ocular vasculitis
Eye disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0011 affected75 at risk
EG0020 affected77 at risk
EG003
Malaise
General disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0021 affected77 at risk
EG003
Asthenia
General disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Post procedural bile leak
Injury, poisoning and procedural complications
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0011 affected75 at risk
EG0020 affected77 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Cutaneous vasculitis
Skin and subcutaneous tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Myopericarditis
Cardiac disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue
General disorders
MedDRA Version 12.0
Systematic Assessment
EG00026 affected78 at risk
EG00135 affected75 at risk
EG00232 affected77 at risk
EG00338 affected79 at risk
EG00437 affected77 at risk
Influenza like illness
General disorders
MedDRA Version 12.0
Systematic Assessment
EG00021 affected78 at risk
EG00132 affected75 at risk
EG00218 affected77 at risk
EG003
Pyrexia
General disorders
MedDRA Version 12.0
Systematic Assessment
EG00018 affected78 at risk
EG00115 affected75 at risk
EG00215 affected77 at risk
EG003
Asthenia
General disorders
MedDRA Version 12.0
Systematic Assessment
EG00020 affected78 at risk
EG00112 affected75 at risk
EG00218 affected77 at risk
EG003
Irritability
General disorders
MedDRA Version 12.0
Systematic Assessment
EG00010 affected78 at risk
EG0017 affected75 at risk
EG00214 affected77 at risk
EG003
Chills
General disorders
MedDRA Version 12.0
Systematic Assessment
EG0004 affected78 at risk
EG0018 affected75 at risk
EG0026 affected77 at risk
EG003
Injection site erythema
General disorders
MedDRA Version 12.0
Systematic Assessment
EG0004 affected78 at risk
EG0018 affected75 at risk
EG0025 affected77 at risk
EG003
Injection site reaction
General disorders
MedDRA Version 12.0
Systematic Assessment
EG0005 affected78 at risk
EG0014 affected75 at risk
EG0022 affected77 at risk
EG003
Pain
General disorders
MedDRA Version 12.0
Systematic Assessment
EG0006 affected78 at risk
EG0012 affected75 at risk
EG0022 affected77 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG00025 affected78 at risk
EG00117 affected75 at risk
EG00230 affected77 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG00021 affected78 at risk
EG00110 affected75 at risk
EG00216 affected77 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG00012 affected78 at risk
EG00112 affected75 at risk
EG00217 affected77 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG00020 affected78 at risk
EG00111 affected75 at risk
EG00211 affected77 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG0003 affected78 at risk
EG0012 affected75 at risk
EG0025 affected77 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG0007 affected78 at risk
EG0011 affected75 at risk
EG0023 affected77 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG0003 affected78 at risk
EG0012 affected75 at risk
EG0023 affected77 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG0006 affected78 at risk
EG0011 affected75 at risk
EG0021 affected77 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0014 affected75 at risk
EG0021 affected77 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0013 affected75 at risk
EG0020 affected77 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 12.0
Systematic Assessment
EG00041 affected78 at risk
EG00134 affected75 at risk
EG00235 affected77 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 12.0
Systematic Assessment
EG00010 affected78 at risk
EG0013 affected75 at risk
EG0024 affected77 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA Version 12.0
Systematic Assessment
EG0005 affected78 at risk
EG0013 affected75 at risk
EG0026 affected77 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 12.0
Systematic Assessment
EG0006 affected78 at risk
EG0011 affected75 at risk
EG0025 affected77 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected75 at risk
EG0024 affected77 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0012 affected75 at risk
EG0022 affected77 at risk
EG003
Migraine
Nervous system disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0021 affected77 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected75 at risk
EG0021 affected77 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 12.0
Systematic Assessment
EG00026 affected78 at risk
EG00116 affected75 at risk
EG00220 affected77 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 12.0
Systematic Assessment
EG00012 affected78 at risk
EG00114 affected75 at risk
EG00211 affected77 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0005 affected78 at risk
EG0013 affected75 at risk
EG0026 affected77 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0005 affected78 at risk
EG0017 affected75 at risk
EG0023 affected77 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0005 affected78 at risk
EG0014 affected75 at risk
EG0026 affected77 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0004 affected78 at risk
EG0015 affected75 at risk
EG0024 affected77 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0006 affected78 at risk
EG0011 affected75 at risk
EG0027 affected77 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0004 affected78 at risk
EG0013 affected75 at risk
EG0024 affected77 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0002 affected78 at risk
EG0011 affected75 at risk
EG0024 affected77 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 12.0
Systematic Assessment
EG00019 affected78 at risk
EG00114 affected75 at risk
EG00223 affected77 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 12.0
Systematic Assessment
EG0008 affected78 at risk
EG0014 affected75 at risk
EG0029 affected77 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA Version 12.0
Systematic Assessment
EG0008 affected78 at risk
EG0013 affected75 at risk
EG0024 affected77 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA Version 12.0
Systematic Assessment
EG0004 affected78 at risk
EG0015 affected75 at risk
EG0021 affected77 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA Version 12.0
Systematic Assessment
EG0004 affected78 at risk
EG0014 affected75 at risk
EG0023 affected77 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 12.0
Systematic Assessment
EG0005 affected78 at risk
EG0012 affected75 at risk
EG0024 affected77 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA Version 12.0
Systematic Assessment
EG0004 affected78 at risk
EG0010 affected75 at risk
EG0021 affected77 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG00017 affected78 at risk
EG00112 affected75 at risk
EG00216 affected77 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG00011 affected78 at risk
EG00112 affected75 at risk
EG00214 affected77 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG0005 affected78 at risk
EG0018 affected75 at risk
EG00210 affected77 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG0004 affected78 at risk
EG0012 affected75 at risk
EG0021 affected77 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0014 affected75 at risk
EG0020 affected77 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected75 at risk
EG0021 affected77 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.0
Systematic Assessment
EG00018 affected78 at risk
EG0019 affected75 at risk
EG00212 affected77 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.0
Systematic Assessment
EG00012 affected78 at risk
EG0018 affected75 at risk
EG0027 affected77 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0006 affected78 at risk
EG0019 affected75 at risk
EG00210 affected77 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.0
Systematic Assessment
EG0005 affected78 at risk
EG0013 affected75 at risk
EG0024 affected77 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 12.0
Systematic Assessment
EG00015 affected78 at risk
EG00123 affected75 at risk
EG00219 affected77 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA Version 12.0
Systematic Assessment
EG00015 affected78 at risk
EG00116 affected75 at risk
EG00217 affected77 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 12.0
Systematic Assessment
EG0002 affected78 at risk
EG0011 affected75 at risk
EG0021 affected77 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0015 affected75 at risk
EG0024 affected77 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0015 affected75 at risk
EG0024 affected77 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 12.0
Systematic Assessment
EG0002 affected78 at risk
EG0012 affected75 at risk
EG0021 affected77 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 12.0
Systematic Assessment
EG0004 affected78 at risk
EG0010 affected75 at risk
EG0021 affected77 at risk
EG003
Weight decreased
Investigations
MedDRA Version 12.0
Systematic Assessment
EG0007 affected78 at risk
EG0013 affected75 at risk
EG0023 affected77 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0015 affected75 at risk
EG0025 affected77 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected75 at risk
EG0025 affected77 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA Version 12.0
Systematic Assessment
EG0003 affected78 at risk
EG0011 affected75 at risk
EG0021 affected77 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA Version 12.0
Systematic Assessment
EG0002 affected78 at risk
EG0011 affected75 at risk
EG0021 affected77 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected75 at risk
EG0020 affected77 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA Version 12.0
Systematic Assessment
EG00010 affected78 at risk
EG00112 affected75 at risk
EG00211 affected77 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA Version 12.0
Systematic Assessment
EG0006 affected78 at risk
EG0013 affected75 at risk
EG0024 affected77 at risk
EG003
Dry eye
Eye disorders
MedDRA Version 12.0
Systematic Assessment
EG0003 affected78 at risk
EG0012 affected75 at risk
EG0023 affected77 at risk
EG003
Vision blurred
Eye disorders
MedDRA Version 12.0
Systematic Assessment
EG0003 affected78 at risk
EG0011 affected75 at risk
EG0025 affected77 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 12.0
Systematic Assessment
EG0005 affected78 at risk
EG0011 affected75 at risk
EG0023 affected77 at risk
EG003
Hot flush
Vascular disorders
MedDRA Version 12.0
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected75 at risk
EG0022 affected77 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 12.0
Systematic Assessment
EG0000 affected78 at risk
EG0011 affected75 at risk
EG0021 affected77 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA Version 12.0
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected75 at risk
EG0025 affected77 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA Version 12.0
Systematic Assessment
EG0006 affected78 at risk
EG0011 affected75 at risk
EG0021 affected77 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
Global Clinical Development Manager
Jan-Cil France
ClinicalTrialDisclosure@its.jnj.com
ID
Term
D006526
Hepatitis C
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D006525
Hepatitis, Viral, Human
D014777
Virus Diseases
D018178
Flaviviridae Infections
D012327
RNA Virus Infections
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069616
Simeprevir
D012254
Ribavirin
C100416
peginterferon alfa-2a
Ancestor Terms
ID
Term
D013449
Sulfonamides
D013450
Sulfones
D013457
Sulfur Compounds
D009930
Organic Chemicals
D006575
Heterocyclic Compounds, 3-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D012263
Ribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
0 subjects
2 subjects
1 subjects
0 subjects
47
(18 to 69)
BG00445(21 to 67)
BG00546.5(18 to 69)
34
BG00335
BG00438
BG005173
Male
BG00040
BG00147
BG00243
BG00344
BG00439
BG005213
7
BG00313
BG0044
BG00542
Europe
Title
Measurements
BG00052
BG00152
BG00256
BG00344
BG00458
BG005262
North-America
Title
Measurements
BG00017
BG00114
BG00214
BG00322
BG00415
BG00582
79
OG00477
84.8
OG00464.9
OG002
OG003
OG004
TMC/PR 150 mg 12 and 24 week treatment groups were pooled and the percentage of participants achieving SVRW72 was compared the percentage of participants achieving SVRW72 in the placebo treatment group.
Regression, Logistic
0.004
Difference in proportions of SVRW72
18.9
2-Sided
97.5
4.4
33.5
Difference in percentages of participants in the TMC435 150mg and placebo groups with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72 estimated from the logistic regression model.
No
Superiority or Other
OG002
TMC435 150 mg 12 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG004
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
Units
Counts
Participants
OG00078
OG00175
OG00277
OG00379
OG00477
Title
Denominators
Categories
Week 2
Title
Measurements
OG00039.7
OG00130.7
OG00223.4
OG00339.2
OG0042.6
Week 4
Title
Measurements
OG00075.6
OG00168.0
OG00275.3
OG003
Week 8
Title
Measurements
OG00087.2
OG00190.7
OG00292.2
OG003
Week 12
Title
Measurements
OG00091.0
OG00193.3
OG00293.5
OG003
Week 24
Title
Measurements
OG00092.3
OG00193.3
OG00284.4
OG003
Week 36
Title
Measurements
OG00085.9
OG00181.3
OG00281.8
OG003
Week 48
Title
Measurements
OG00079.5
OG00177.3
OG00279.2
OG003
Week 60
Title
Measurements
OG00079.5
OG00168.0
OG00275.3
OG003
Week 72
Title
Measurements
OG00079.5
OG00170.7
OG00277.9
OG003
EOT (up to Week 24 or 48)
Title
Measurements
OG00092.3
OG00197.3
OG00292.2
OG003
OG002
TMC435 150 mg 12 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG004
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
Units
Counts
Participants
OG00078
OG00175
OG00277
OG00379
OG00477
Title
Denominators
Categories
Week 2
Title
Measurements
OG00065.4
OG00166.7
OG00275.3
OG00378.5
OG0045.2
Week 4
Title
Measurements
OG00085.9
OG00188.0
OG00290.9
OG003
Week 8
Title
Measurements
OG00093.6
OG00194.7
OG00293.5
OG003
Week 12
Title
Measurements
OG00093.6
OG00194.7
OG00296.1
OG003
Week 24
Title
Measurements
OG00092.3
OG00193.3
OG00284.4
OG003
Week 36
Title
Measurements
OG00085.9
OG00181.3
OG00281.8
OG003
Week 48
Title
Measurements
OG00079.5
OG00177.3
OG00279.2
OG003
Week 60
Title
Measurements
OG00079.5
OG00168.0
OG00275.3
OG003
Week 72
Title
Measurements
OG00079.5
OG00170.7
OG00277.9
OG003
EOT (up to Week 24 or 48)
Title
Measurements
OG00093.6
OG00197.3
OG00292.2
OG003
TMC435 150 mg 12 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG004
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
Units
Counts
Participants
OG00078
OG00175
OG00277
OG00379
OG00477
Title
Denominators
Categories
Week 2
Title
Measurements
OG00093.6
OG00198.7
OG00297.4
OG00398.7
OG00440.3
Week 4
Title
Measurements
OG00094.9
OG00198.7
OG00297.4
OG003
Week 8
Title
Measurements
OG00097.4
OG00197.3
OG00297.4
OG003
Week 12
Title
Measurements
OG00097.4
OG00196.0
OG00296.1
OG003
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG004
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
Units
Counts
Participants
OG00078
OG00175
OG00277
OG00379
OG00477
Title
Denominators
Categories
Title
Measurements
OG00082.1
OG00174.7
OG00280.5
OG00386.1
OG00464.9
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG004
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
Units
Counts
Participants
OG00078
OG00175
OG00277
OG00379
OG00477
Title
Denominators
Categories
Title
Measurements
OG00075.6
OG00168.0
OG00275.3
OG00374.7
OG0045.2
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG004
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
Units
Counts
Participants
OG00078
OG00175
OG00277
OG00379
OG00477
Title
Denominators
Categories
Title
Measurements
OG00097.4
OG00196.0
OG00296.1
OG00396.2
OG00489.6
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG004
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
Units
Counts
Participants
OG00078
OG00175
OG00277
OG00379
OG00477
Title
Denominators
Categories
Title
Measurements
OG00091.0
OG00193.3
OG00293.5
OG00394.9
OG00455.8
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG004
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
Units
Counts
Participants
OG00078
OG00175
OG00277
OG00379
OG00477
Title
Denominators
Categories
Title
Measurements
OG00083.3
OG00176.0
OG00280.5
OG00386.1
OG00466.2
OG002
TMC435 150 mg 12 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG004
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
Units
Counts
Participants
OG00078
OG00175
OG00277
OG00379
OG00477
Title
Denominators
Categories
Title
Measurements
OG0005
OG0012
OG0026
OG0032
OG0044
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG004
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
Units
Counts
Participants
OG00078
OG00175
OG00277
OG00379
OG00477
Title
Denominators
Categories
Title
Measurements
OG0008
OG00114
OG0026
OG0036
OG00411
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG004
All TMC435 Treatment Groups
Participants in all 4 TMC435 treatment groups combined.
Units
Counts
Participants
OG00043
OG00145
OG00248
OG00343
OG004179
Title
Denominators
Categories
Title
Measurements
OG00039
OG00137
OG00239
OG00335
OG004150
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
Units
Counts
Participants
OG00077
OG00175
OG00277
OG00378
Title
Denominators
Categories
Coh
Title
Measurements
OG000240.9(0 to 1927)
OG001213.6(40 to 2124)
OG0021123.3(91 to 13771)
OG0031176.7(0 to 9875)
Css, av
Title
Measurements
OG000413.6(6 to 2091)
OG001374.0(151 to 2385)
OG0021661.8(123 to 15868)
OG003
OG002
TMC435 150 mg 12 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
OG003
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.