A Safety and Effectiveness Study of TMC435 in Chronic, Ge... | NCT00980330 | Trialant
NCT00980330
Sponsor
Tibotec Pharmaceuticals, Ireland
Status
Completed
Last Update Posted
Jun 9, 2014Estimated
Enrollment
463Actual
Phase
Phase 2
Conditions
Hepatitis C
Interventions
TMC435
Placebo
Peg-IFN-alfa-2a (P)
Ribavirin (R)
Countries
United States
Australia
Austria
Belgium
Canada
France
Germany
Israel
New Zealand
Norway
Poland
Portugal
Russia
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00980330
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR016063
Secondary IDs
ID
Type
Description
Link
TMC435-TiDP16-C206
Other Identifier
Tibotec Pharmaceuticals, Ireland
2009-010590-20
EudraCT Number
Brief Title
A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard 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 PegIFNa-2a and Ribavirin in HCV Genotype 1 Infected Subjects Who Failed Previous Standard Therapy
Acronym
ASPIRE
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
Oct 2009
Primary Completion Date
Aug 2011Actual
Completion Date
Aug 2011Actual
First Submitted Date
Sep 10, 2009
First Submission Date that Met QC Criteria
Sep 18, 2009
First Posted Date
Sep 21, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 18, 2013
Results First Submitted that Met QC Criteria
Dec 18, 2013
Results First Posted Date
Feb 6, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 20, 2011
Certification/Extension First Submitted that Passed QC Review
Jun 20, 2011
Certification/Extension First Posted Date
Jun 28, 2011Estimated
Last Update Submitted Date
May 30, 2014
Last Update Posted Date
Jun 9, 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 determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).
Detailed Description
The study is a randomized (study drug assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled Phase IIb trial with TMC435 in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who have failed standard treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV). The study will compare the efficacy, tolerability and safety of different regimens with TMC435 combined with standard treatment (Peg-INF-alfa-2a and RBV) versus standard treatment alone. The trial will consist of a screening period of maximum 6 weeks, a 48-week treatment period, and a 24-week follow-up period. Participants will be eligible to enroll in the trial if they failed to respond to a prior course of standard treatment or relapsed following standard treatment. Participants will be randomly assigned to receive TMC435 with standard treatment for 12 weeks followed by standard treatment (plus placebo) for 36 weeks, TMC435 (100 mg or 150 mg once a day) with standard treatment for 24 weeks followed by standard treatment (plus placebo) for 24 weeks, TMC435 (100 mg or 150 mg once a day) with standard treatment for 48 weeks, or a placebo with standard treatment for 48 weeks.
Conditions Module
Conditions
Hepatitis C
Keywords
Hepatitis C
Peginterferon alpha-2a
PegIFNalpha-2a
RBV
Ribavirin
Placebo
TMC435-TIDP16-C206
TMC435-C206
TMC435
HCV
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
463Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
TMC435 100 mg 12 Wks + PR48
Experimental
Participants will receive TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
Drug: TMC435
Drug: Placebo
Drug: Peg-IFN-alfa-2a (P)
Drug: Ribavirin (R)
TMC435 100 mg 24 Wks + PR48
Experimental
Participants willl receive TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
Drug: TMC435
Drug: Placebo
Drug: Peg-IFN-alfa-2a (P)
Drug: Ribavirin (R)
TMC435 100 mg 48 Wks + PR48
Experimental
Participants will receive TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Drug: TMC435
Drug: Placebo
Drug: Peg-IFN-alfa-2a (P)
Drug: Ribavirin (R)
TMC435 150 mg 12 Wks + PR48
Experimental
Participants will receive TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
Drug: TMC435
Drug: Placebo
Drug: Peg-IFN-alfa-2a (P)
Drug: Ribavirin (R)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TMC435
Drug
One TMC435 100-mg capsule or two 75-mg capsules orally (by mouth) once daily for 12, 24, or 48 weeks.
Placebo 48 Wks + PR48
TMC435 100 mg 12 Wks + PR48
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)
The table below shows the percentage of participants in the overall population with an SVR24, defined as having plasma levels of Hepatitis C Virus ribonucleic acid less than 25 IU/mL undetectable at the EOT and 24 weeks after the EOT.
Week 72
Secondary Outcomes
Measure
Description
Time Frame
The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment
The table below shows the percentage of participants in each treatment group who achieved a greater than 2 log10 drop in plasma levels of HCV RNA at selected time points during treatment.
Weeks, 2, 4, 8, and 12
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Must have chronic hepatitis C infection as evidenced by liver biopsy, anti-hepatitis C virus (HCV) and HCV RNA positive
Must have chronic hepatitis C infection (genotype 1) with HCV RNA level greater than10000 IU/mL
Patient must have failed at least 1 prior course of peg interferon (Peg-IFN-alfa-2a)/ribavirin (RBV) therapy (standard treatment)
Must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Exclusion Criteria:
Has an evidence of decompensated liver disease
Co-infection with any other Hepatitis C virus genotype or co-infection with the human immunodeficiency virus (HIV)
Has a medical condition which is a contraindication to Peg-INF or RBV therapy
Have had 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.
A total of 618 participants were screened. Of these, 463 participants were randomized of whom 462 participants started treatment. One participant in the placebo group was 'randomized in error,' did not receive treatment, and was withdrawn from the study due to non-compliance (did not come for visit).
Recruitment Details
The study was conducted at 89 sites in 14 countries.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
Participants will receive TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
Drug: TMC435
Drug: Placebo
Drug: Peg-IFN-alfa-2a (P)
Drug: Ribavirin (R)
TMC435 150 mg 48 Wks + PR48
Experimental
Participants will receive TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Drug: TMC435
Drug: Peg-IFN-alfa-2a (P)
Drug: Ribavirin (R)
Placebo 48 Wks + PR48
Placebo Comparator
Participants will receive Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Drug: TMC435
Drug: Peg-IFN-alfa-2a (P)
Drug: Ribavirin (R)
TMC435 100 mg 24 Wks + PR48
TMC435 100 mg 48 Wks + PR48
TMC435 150 mg 12 Wks + PR48
TMC435 150 mg 24 Wks + PR48
TMC435 150 mg 48 Wks + PR48
Placebo
Drug
One or 2 capsules of placebo identical in appearance to TMC435 taken orally once daily for 24, 36, or 48 weeks.
TMC435 100 mg 12 Wks + PR48
TMC435 100 mg 24 Wks + PR48
TMC435 100 mg 48 Wks + PR48
TMC435 150 mg 12 Wks + PR48
TMC435 150 mg 24 Wks + PR48
Peg-IFN-alfa-2a (P)
Drug
180 micrograms taken as one 0.5 mL subcutaneous injection once weekly for 48 weeks.
Placebo 48 Wks + PR48
TMC435 100 mg 12 Wks + PR48
TMC435 100 mg 24 Wks + PR48
TMC435 100 mg 48 Wks + PR48
TMC435 150 mg 12 Wks + PR48
TMC435 150 mg 24 Wks + PR48
TMC435 150 mg 48 Wks + PR48
PEGASYS
Ribavirin (R)
Drug
1000 or 1200 mg/day (5 or 6 tablets) taken orally as a twice daily regimen taken for 48 weeks.
Placebo 48 Wks + PR48
TMC435 100 mg 12 Wks + PR48
TMC435 100 mg 24 Wks + PR48
TMC435 100 mg 48 Wks + PR48
TMC435 150 mg 12 Wks + PR48
TMC435 150 mg 24 Wks + PR48
TMC435 150 mg 48 Wks + PR48
COPEGUS
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up
The table below shows the percentage of participants in each treatment who achieved plasma HCV RNA levels of <25 IU/mL undetectable at selected time points during treatment and follow-up and at the end of treatment (EOT).
Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72 and EOT (up to Week 48)
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <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 HCV RNA levels below the limit of quantification defined as less than 25 IU/mL (detectable or undetectable) at selected time points during treatment, follow-up, and at the end of treatment (EOT).
Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)
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 an undetectable plasma Hepatitis C virus ribonucleic acid level 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 greater than or equal to 2 log10 reduction in plasma Hepatitis C virus ribonucleic acid from baseline at Week 12.
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 levels of Hepatitis C virus ribonucleic acid 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 in the overall population who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the planned EOT.
Week 60
The Percentage of Participants With Viral Breakthrough
The table below shows the percentage of participants in the overall population in each treatment group during the treatment period who experienced viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in Hepatitis C virus (HCV) ribonucleic acid (RNA) from the lowest level reached or a confirmed HCV RNA of > 100 IU/mL in participants whose HCV RNA had previously been below the lower limit of quantification (i.e., less than 25 IU/mL detectable or undetectable).
EOT (up to Week 48)
The Percentage of Participants With Viral Relapse
The table below shows the percentage of participants in the overall population who had viral relapse, defined as confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with HCV RNA less than 25 IU/mL undetectable at end of treatment.
Up to Week 72
The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)
The table below shows the number of participants with abnormal ALT levels at Baseline who achieved the normal ALT levels at the EOT (up to Week 48).
EOT (up to Week 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 TMC435 for participants in each of the 6 TMC435 treatment groups.
0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48
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 TMC435 treatment group.
0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48
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.
Zeuzem S, Berg T, Gane E, Ferenci P, Foster GR, Fried MW, Hezode C, Hirschfield GM, Jacobson I, Nikitin I, Pockros PJ, Poordad F, Scott J, Lenz O, Peeters M, Sekar V, De Smedt G, Sinha R, Beumont-Mauviel M. Simeprevir increases rate of sustained virologic response among treatment-experienced patients with HCV genotype-1 infection: a phase IIb trial. Gastroenterology. 2014 Feb;146(2):430-41.e6. doi: 10.1053/j.gastro.2013.10.058. Epub 2013 Nov 1.
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
FG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
FG003
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
FG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
FG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
FG006
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
FG00066 subjects
FG00165 subjects
FG00266 subjects
FG00366 subjects
FG00468 subjects
FG00565 subjects
FG00666 subjects
COMPLETED
FG00061 subjects
FG00160 subjects
FG00258 subjects
FG00361 subjects
FG00463 subjects
FG00561 subjects
FG00659 subjects
NOT COMPLETED
FG0005 subjects
FG0015 subjects
FG0028 subjects
FG0035 subjects
FG0045 subjects
FG0054 subjects
FG0067 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0024 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0014 subjects
FG0024 subjects
FG0031 subjects
FG004
(not specified)
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
BG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
BG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
BG003
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
BG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
BG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
BG006
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00066
BG00165
BG00266
BG00366
BG00468
BG00565
BG00666
BG007462
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
BG00051.5(20 to 68)
BG00150(20 to 68)
BG00250(22 to 69)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00022
BG00121
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Asia Pacific
Title
Measurements
BG0004
BG0015
BG002
Prior PR response
In the study, "Null Responders" were participants with less than 2 log10 IU/mL reduction in HCV RNA compared to baseline at Week 12 of the previous PegIFNα-2a/b and RBV treatment; "Partial Responders" were participants with a greater than or equal to 2 log10 IU/mL reduction in HCV RNA compared to baseline at Week 12, but not achieving an undetectable HCV RNA at the end of the previous PegIFNα-2a/b and RBV treatment; and "Relapsers" were participants with HCV RNA undetectable at end of the previous treatment with PegIFNα-2a/b and RBV, but detectable HCV RNA within 24 weeks of follow-up.
Number
participants
Title
Denominators
Categories
Null responder
Title
Measurements
BG00016
BG001
Metavir Score
A Metavir score is used to interpret the degree of inflammation and fibrosis in a liver biopsy. Below are fibrosis scores graded on a 5-point scale from F0 (no fibrosis) to F4 (cirrhosis).
Number
participants
Title
Denominators
Categories
Not reported
Title
Measurements
BG0001
BG0012
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 the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)
The table below shows the percentage of participants in the overall population with an SVR24, defined as having plasma levels of Hepatitis C Virus ribonucleic acid less than 25 IU/mL undetectable at the EOT and 24 weeks after the EOT.
Intent-to-treat: Participants who received at least 1 dose of study medication were included.
Posted
Number
Percentage of participants
Week 72
ID
Title
Description
OG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
OG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
OG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG003
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
OG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
OG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG006
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Units
Counts
Participants
OG00066
OG00165
OG00266
OG003
Title
Denominators
Categories
Title
Measurements
OG00069.7
OG00166.2
OG00260.6
OG003
Secondary
The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment
The table below shows the percentage of participants in each treatment group who achieved a greater than 2 log10 drop in plasma levels of HCV RNA at selected time points during treatment.
Intent-to-treat: Participants who received at least 1 dose of study medication were included.
Posted
Number
Percentage of participants
Weeks, 2, 4, 8, and 12
ID
Title
Description
OG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
OG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
OG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Secondary
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up
The table below shows the percentage of participants in each treatment who achieved plasma HCV RNA levels of <25 IU/mL undetectable at selected time points during treatment and follow-up and at the end of treatment (EOT).
Intent-to-treat: Participants who received at least 1 dose of study medication were included.
Posted
Number
Percentage of participants
Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72 and EOT (up to Week 48)
ID
Title
Description
OG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
OG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
OG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Secondary
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <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 HCV RNA levels below the limit of quantification defined as less than 25 IU/mL (detectable or undetectable) at selected time points during treatment, follow-up, and at the end of treatment (EOT).
Intent-to-treat: Participants who received at least 1 dose of study medication were included.
Posted
Number
Percentage of Participants
Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)
ID
Title
Description
OG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
OG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
OG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
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 an undetectable plasma Hepatitis C virus ribonucleic acid level after receiving 4 weeks of treatment.
Intent-to-treat: Participants who received at least 1 dose of study medication were included.
Posted
Number
Percentage of participants
Week 4
ID
Title
Description
OG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
OG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
OG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG003
TMC435 150mg 12 Wks + PR48
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 greater than or equal to 2 log10 reduction in plasma Hepatitis C virus ribonucleic acid from baseline at Week 12.
Intent-to-treat: Participants who received at least 1 dose of study medication were included.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
OG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
OG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG003
TMC435 150mg 12 Wks + PR48
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 levels of Hepatitis C virus ribonucleic acid at Week 12.
Intent-to-treat: Participants who received at least 1 dose of study medication were included.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
OG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
OG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG003
TMC435 150mg 12 Wks + PR48
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 in the overall population who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the planned EOT.
Intent-to-treat: Participants who received at least 1 dose of study medication were included.
Posted
Number
Percentage of participants
Week 60
ID
Title
Description
OG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
OG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
OG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG003
Secondary
The Percentage of Participants With Viral Breakthrough
The table below shows the percentage of participants in the overall population in each treatment group during the treatment period who experienced viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in Hepatitis C virus (HCV) ribonucleic acid (RNA) from the lowest level reached or a confirmed HCV RNA of > 100 IU/mL in participants whose HCV RNA had previously been below the lower limit of quantification (i.e., less than 25 IU/mL detectable or undetectable).
Intent-to-treat: Participants who received at least 1 dose of study medication were included.
Posted
Number
Percentage of participants
EOT (up to Week 48)
ID
Title
Description
OG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
OG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
OG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Secondary
The Percentage of Participants With Viral Relapse
The table below shows the percentage of participants in the overall population who had viral relapse, defined as confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with HCV RNA less than 25 IU/mL undetectable at end of treatment.
Intent-to-treat: Participants who received at least 1 dose of study medication were included.
Posted
Number
Percentage of participants
Up to Week 72
ID
Title
Description
OG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
OG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
OG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG003
Secondary
The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)
The table below shows the number of participants with abnormal ALT levels at Baseline who achieved the normal ALT levels at the EOT (up to Week 48).
Intent-to-treat: Participants who received at least 1 dose of study medication were included.
Posted
Number
Percentage of participants
EOT (up to Week 48)
ID
Title
Description
OG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
OG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
OG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG003
TMC435 150mg 12 Wks + PR48
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 TMC435 for participants in each of the 6 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
0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48
ID
Title
Description
OG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
OG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
OG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
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 TMC435 treatment group.
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
0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48
ID
Title
Description
OG000
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
OG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
OG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Time Frame
Week 72
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
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
3
66
63
66
EG001
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
5
65
61
65
EG002
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
3
66
65
66
EG003
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
7
66
63
66
EG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
5
68
65
68
EG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
8
65
63
65
EG006
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
4
66
63
66
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Urinary tract infection
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0012 affected65 at risk
EG0020 affected66 at risk
EG0031 affected66 at risk
EG004
Cellulitis
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0011 affected65 at risk
EG0021 affected66 at risk
EG003
Gingival infection
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0021 affected66 at risk
EG003
Lung infection
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Meningitis bacterial
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Pneumonia bordetella
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Salpingitis
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA Version 14.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Haemorrhagic anaemia
Blood and lymphatic system disorders
MedDRA Version 14.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 14.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA Version 14.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 14.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected65 at risk
EG0020 affected66 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 14.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected65 at risk
EG0020 affected66 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 14.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA Version 14.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA Version 14.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA Version 14.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0021 affected66 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 14.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 14.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Hepatic neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Neurilemmoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0011 affected65 at risk
EG0020 affected66 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Histiocytosis haematophagic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Brain injury
Nervous system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Coma
Nervous system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Migraine
Nervous system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Viith nerve paralysis
Nervous system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0011 affected65 at risk
EG0020 affected66 at risk
EG003
Sciatica
Nervous system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0011 affected65 at risk
EG0020 affected66 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA Version 14.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected65 at risk
EG0020 affected66 at risk
EG003
Pyrexia
General disorders
MedDRA Version 14.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected65 at risk
EG0020 affected66 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Alcohol abuse
Psychiatric disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Pelvic adhesions
Reproductive system and breast disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0021 affected66 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0011 affected65 at risk
EG0020 affected66 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Weight decreased
Investigations
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0020 affected66 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue
General disorders
MedDRA Version 14.0
Non-systematic Assessment
EG00030 affected66 at risk
EG00128 affected65 at risk
EG00234 affected66 at risk
EG00326 affected66 at risk
EG00428 affected68 at risk
EG00528 affected65 at risk
EG00629 affected66 at risk
Influenza like illness
General disorders
MedDRA Version 14.0
Non-systematic Assessment
EG00023 affected66 at risk
EG00124 affected65 at risk
EG00221 affected66 at risk
EG003
Asthenia
General disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0006 affected66 at risk
EG00116 affected65 at risk
EG00211 affected66 at risk
EG003
Pyrexia
General disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0006 affected66 at risk
EG00110 affected65 at risk
EG00213 affected66 at risk
EG003
Irritability
General disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0009 affected66 at risk
EG0018 affected65 at risk
EG00210 affected66 at risk
EG003
Chills
General disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0007 affected66 at risk
EG0014 affected65 at risk
EG0024 affected66 at risk
EG003
Injection site erythema
General disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0003 affected66 at risk
EG0014 affected65 at risk
EG0021 affected66 at risk
EG003
Injection site reaction
General disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0003 affected66 at risk
EG0012 affected65 at risk
EG0024 affected66 at risk
EG003
Pain
General disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0012 affected65 at risk
EG0021 affected66 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 14.0
Non-systematic Assessment
EG00019 affected66 at risk
EG00126 affected65 at risk
EG00221 affected66 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0009 affected66 at risk
EG00115 affected65 at risk
EG00212 affected66 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0008 affected66 at risk
EG0018 affected65 at risk
EG0026 affected66 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0005 affected66 at risk
EG0013 affected65 at risk
EG0027 affected66 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0004 affected66 at risk
EG0015 affected65 at risk
EG0027 affected66 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0003 affected66 at risk
EG0013 affected65 at risk
EG0025 affected66 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0011 affected65 at risk
EG0022 affected66 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0011 affected65 at risk
EG0025 affected66 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG00017 affected66 at risk
EG00110 affected65 at risk
EG00220 affected66 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0009 affected66 at risk
EG00111 affected65 at risk
EG00213 affected66 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0006 affected66 at risk
EG0014 affected65 at risk
EG0024 affected66 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0003 affected66 at risk
EG0014 affected65 at risk
EG0021 affected66 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0003 affected66 at risk
EG0012 affected65 at risk
EG0025 affected66 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0002 affected66 at risk
EG0012 affected65 at risk
EG0024 affected66 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0013 affected65 at risk
EG0023 affected66 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0002 affected66 at risk
EG0011 affected65 at risk
EG0022 affected66 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0014 affected65 at risk
EG0022 affected66 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0002 affected66 at risk
EG0014 affected65 at risk
EG0022 affected66 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0011 affected65 at risk
EG0024 affected66 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0011 affected65 at risk
EG0024 affected66 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG00018 affected66 at risk
EG00119 affected65 at risk
EG00223 affected66 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0014 affected65 at risk
EG0027 affected66 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0003 affected66 at risk
EG0018 affected65 at risk
EG0025 affected66 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0005 affected66 at risk
EG0012 affected65 at risk
EG0026 affected66 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 14.0
Non-systematic Assessment
EG00011 affected66 at risk
EG00111 affected65 at risk
EG00216 affected66 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0007 affected66 at risk
EG0018 affected65 at risk
EG0028 affected66 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0005 affected66 at risk
EG0012 affected65 at risk
EG0025 affected66 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0005 affected66 at risk
EG0012 affected65 at risk
EG0023 affected66 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0002 affected66 at risk
EG0012 affected65 at risk
EG0023 affected66 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0002 affected66 at risk
EG0010 affected65 at risk
EG0023 affected66 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG00016 affected66 at risk
EG00115 affected65 at risk
EG00215 affected66 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG00014 affected66 at risk
EG00111 affected65 at risk
EG00212 affected66 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0002 affected66 at risk
EG0012 affected65 at risk
EG0021 affected66 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0011 affected65 at risk
EG0021 affected66 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG00010 affected66 at risk
EG00118 affected65 at risk
EG00213 affected66 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG00010 affected66 at risk
EG0019 affected65 at risk
EG0028 affected66 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0004 affected66 at risk
EG0014 affected65 at risk
EG0024 affected66 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0013 affected65 at risk
EG0023 affected66 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0010 affected65 at risk
EG0024 affected66 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0002 affected66 at risk
EG0011 affected65 at risk
EG0020 affected66 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 14.0
Non-systematic Assessment
EG00016 affected66 at risk
EG0014 affected65 at risk
EG0026 affected66 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0007 affected66 at risk
EG0015 affected65 at risk
EG0029 affected66 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0002 affected66 at risk
EG0012 affected65 at risk
EG0022 affected66 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0004 affected66 at risk
EG0013 affected65 at risk
EG0021 affected66 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0017 affected65 at risk
EG0021 affected66 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0013 affected65 at risk
EG0023 affected66 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0007 affected66 at risk
EG0010 affected65 at risk
EG0023 affected66 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 14.0
Non-systematic Assessment
EG0004 affected66 at risk
EG0011 affected65 at risk
EG0020 affected66 at risk
EG003
Weight decreased
Investigations
MedDRA Version 14.0
Non-systematic Assessment
EG0004 affected66 at risk
EG0013 affected65 at risk
EG0023 affected66 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA Version 14.0
Non-systematic Assessment
EG0002 affected66 at risk
EG0015 affected65 at risk
EG0020 affected66 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA Version 14.0
Non-systematic Assessment
EG0002 affected66 at risk
EG0012 affected65 at risk
EG0021 affected66 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA Version 14.0
Non-systematic Assessment
EG0000 affected66 at risk
EG0011 affected65 at risk
EG0020 affected66 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA Version 14.0
Non-systematic Assessment
EG00011 affected66 at risk
EG00111 affected65 at risk
EG00211 affected66 at risk
EG003
Dry eye
Eye disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0014 affected65 at risk
EG0024 affected66 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0010 affected65 at risk
EG0022 affected66 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0003 affected66 at risk
EG0011 affected65 at risk
EG0022 affected66 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0002 affected66 at risk
EG0014 affected65 at risk
EG0024 affected66 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA Version 14.0
Non-systematic Assessment
EG0001 affected66 at risk
EG0011 affected65 at risk
EG0022 affected66 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
C100416
peginterferon alfa-2a
D012254
Ribavirin
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
1 subjects
FG0051 subjects
FG0062 subjects
3 subjects
FG0052 subjects
FG0065 subjects
1 subjects
FG0051 subjects
FG0060 subjects
48
(20 to 63)
BG00451.5(25 to 68)
BG00550(21 to 69)
BG00650.5(22 to 66)
BG00750(20 to 69)
21
BG00321
BG00425
BG00517
BG00624
BG007151
Male
BG00044
BG00144
BG00245
BG00345
BG00443
BG00548
BG00642
BG007311
4
BG0034
BG0041
BG0054
BG0067
BG00729
Europe and Israel
Title
Measurements
BG00034
BG00146
BG00246
BG00349
BG00449
BG00543
BG00646
BG007313
North-America
Title
Measurements
BG00028
BG00114
BG00216
BG00313
BG00418
BG00518
BG00613
BG007120
16
BG00218
BG00317
BG00417
BG00517
BG00616
BG007117
Partial responder
Title
Measurements
BG00023
BG00123
BG00222
BG00323
BG00424
BG00522
BG00623
BG007160
Relapser
Title
Measurements
BG00027
BG00126
BG00226
BG00326
BG00427
BG00526
BG00627
BG007185
BG0020
BG0030
BG0041
BG0051
BG0062
BG0077
Score F0
Title
Measurements
BG0006
BG0013
BG0026
BG0035
BG00411
BG0051
BG0067
BG00739
Score F1
Title
Measurements
BG00017
BG00114
BG00223
BG00319
BG00411
BG00527
BG00618
BG007129
Score F2
Title
Measurements
BG00021
BG00117
BG0029
BG00318
BG00421
BG00516
BG00616
BG007118
Score F3
Title
Measurements
BG00014
BG00116
BG00214
BG00311
BG00411
BG0057
BG00613
BG00786
Score F4
Title
Measurements
BG0007
BG00113
BG00214
BG00313
BG00413
BG00513
BG00610
BG00783
66
OG00468
OG00565
OG00666
66.7
OG00472.1
OG00580.0
OG00622.7
OG003
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
OG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
OG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG006
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Units
Counts
Participants
OG00066
OG00165
OG00266
OG00366
OG00468
OG00565
OG00666
Title
Denominators
Categories
Week 2
Title
Measurements
OG00097.0
OG00193.8
OG00297.0
OG003100.0
OG00495.6
OG00596.9
OG00624.2
Week 4
Title
Measurements
OG00092.4
OG00193.8
OG00292.4
OG003
Week 8
Title
Measurements
OG00092.4
OG00189.2
OG00289.4
OG003
Week 12
Title
Measurements
OG00090.9
OG00187.7
OG00284.8
OG003
OG003
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
OG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
OG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG006
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Units
Counts
Participants
OG00066
OG00165
OG00266
OG00366
OG00468
OG00565
OG00666
Title
Denominators
Categories
Week 2
Title
Measurements
OG00022.7
OG00118.5
OG00215.2
OG00324.2
OG00432.4
OG00527.7
OG0060.0
Week 4
Title
Measurements
OG00066.7
OG00158.5
OG00253.0
OG003
Week 8
Title
Measurements
OG00077.3
OG00175.4
OG00277.3
OG003
Week 12
Title
Measurements
OG00081.8
OG00173.8
OG00272.7
OG003
Week 24
Title
Measurements
OG00081.8
OG00175.4
OG00278.8
OG003
Week 36
Title
Measurements
OG00078.8
OG00173.8
OG00278.8
OG003
Week 48
Title
Measurements
OG00081.8
OG00173.8
OG00274.2
OG003
Week 60
Title
Measurements
OG00069.7
OG00167.7
OG00259.1
OG003
Week 72
Title
Measurements
OG00069.7
OG00166.2
OG00260.6
OG003
EOT (up to Week 48)
Title
Measurements
OG00080.3
OG00178.5
OG00280.3
OG003
OG003
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
OG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
OG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG006
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Units
Counts
Participants
OG00066
OG00165
OG00266
OG00366
OG00468
OG00565
OG00666
Title
Denominators
Categories
Week 2
Title
Measurements
OG00060.6
OG00155.4
OG00254.5
OG00363.6
OG00460.3
OG00566.2
OG0063.0
Week 4
Title
Measurements
OG00078.8
OG00172.3
OG00281.8
OG003
Week 8
Title
Measurements
OG00087.9
OG00181.5
OG00284.8
OG003
Week 12
Title
Measurements
OG00087.9
OG00181.5
OG00283.3
OG003
Week 24
Title
Measurements
OG00084.8
OG00178.5
OG00280.3
OG003
Week 36
Title
Measurements
OG00081.8
OG00173.8
OG00278.8
OG003
Week 48
Title
Measurements
OG00083.3
OG00173.8
OG00274.2
OG003
Week 60
Title
Measurements
OG00071.2
OG00167.7
OG00260.6
OG003
Week 72
Title
Measurements
OG00069.7
OG00166.2
OG00260.6
OG003
EOT (up to Week 48)
Title
Measurements
OG00086.4
OG00181.5
OG00281.8
OG003
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
OG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
OG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG006
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Units
Counts
Participants
OG00066
OG00165
OG00266
OG00366
OG00468
OG00565
OG00666
Title
Denominators
Categories
Title
Measurements
OG00066.7
OG00158.5
OG00253.0
OG00362.1
OG00467.6
OG00566.2
OG0061.5
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
OG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
OG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG006
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Units
Counts
Participants
OG00066
OG00165
OG00266
OG00366
OG00468
OG00565
OG00666
Title
Denominators
Categories
Title
Measurements
OG00090.9
OG00187.7
OG00284.8
OG00392.4
OG00491.2
OG00592.3
OG00660.6
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
OG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
OG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG006
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Units
Counts
Participants
OG00066
OG00165
OG00266
OG00366
OG00468
OG00565
OG00666
Title
Denominators
Categories
Title
Measurements
OG00081.8
OG00173.8
OG00272.7
OG00380.3
OG00485.3
OG00583.1
OG00619.7
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
OG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
OG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG006
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Units
Counts
Participants
OG00066
OG00165
OG00266
OG00366
OG00468
OG00565
OG00666
Title
Denominators
Categories
Title
Measurements
OG00069.7
OG00167.7
OG00260.6
OG00366.7
OG00472.1
OG00580.0
OG00622.7
OG003
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
OG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
OG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG006
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Units
Counts
Participants
OG00066
OG00165
OG00266
OG00366
OG00468
OG00565
OG00666
Title
Denominators
Categories
Title
Measurements
OG00010.6
OG00113.8
OG00213.6
OG0039.1
OG00410.3
OG0057.7
OG0061.5
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
OG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
OG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG006
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Units
Counts
Participants
OG00066
OG00165
OG00266
OG00366
OG00468
OG00565
OG00666
Title
Denominators
Categories
Title
Measurements
OG0009.3
OG00113.7
OG00218.0
OG00311.8
OG00414.0
OG0055.5
OG00644.4
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
OG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
OG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
OG006
All TMC435
Participants in all 6 TMC435 treatment groups combined.
Units
Counts
Participants
OG00036
OG00149
OG00245
OG00340
OG00443
OG00543
OG006256
Title
Denominators
Categories
Title
Measurements
OG00026
OG00137
OG00231
OG00323
OG00431
OG00533
OG006181
OG003
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
OG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
OG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Units
Counts
Participants
OG00066
OG00165
OG00265
OG00366
OG00468
OG00564
Title
Denominators
Categories
C0h
Title
Measurements
OG000380.5(34 to 3599)
OG001411.3(101 to 6943)
OG002529.8(62 to 4212)
OG0031323.5(37 to 12478)
OG0041074.0(110 to 14303)
OG005886.1(150 to 21825)
Css,av
Title
Measurements
OG000691.1(204 to 3960)
OG001770.5(344 to 7218)
OG002892.0(290 to 4580)
OG003
OG003
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
OG004
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
OG005
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.