Safety, Antiviral Activity and PK of MRD of BI 201335 in... | NCT00793793 | Trialant
NCT00793793
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Sep 5, 2018Actual
Enrollment
96Actual
Phase
Phase 1
Conditions
Hepatitis C, Chronic
Interventions
BI201335
BI201335
BI201335
BI201335
Placebo
Countries
United States
France
Germany
Spain
Protocol Section
Identification Module
NCT ID
NCT00793793
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1220.2
Secondary IDs
ID
Type
Description
Link
2007-001158-19
EudraCT Number
Brief Title
Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
Official Title
Safety, Antiviral Activity, and Pharmacokinetics of Multiple Rising Oral Doses of BI 201335 NA in Treatment-naïve Patients With Chronic Hepatitis C Infection for 14 Days Monotherapy Followed by Combination With Pegylated Interferon and Ribavirin for an Additional 14 Days (Double-blind, Placebo Controlled), and in Treatment-experienced Patients With Chronic Hepatitis C Infection for 28 Days as Combination Therapy With Pegylated Interferon and Ribavirin (Open-label)
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Aug 2018
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
Sep 2007
Primary Completion Date
Jan 2011Actual
Completion Date
Jan 25, 2011Actual
First Submitted Date
Sep 23, 2008
First Submission Date that Met QC Criteria
Nov 18, 2008
First Posted Date
Nov 19, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 3, 2015
Results First Submitted that Met QC Criteria
Aug 18, 2015
Results First Posted Date
Sep 17, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 7, 2018
Last Update Posted Date
Sep 5, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients.
A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.
Detailed Description
Not provided
Conditions Module
Conditions
Hepatitis C, Chronic
Keywords
Not provided
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
96Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
20mg
Experimental
patient to receive 20mg solution BI201335 qd +/- PegIFN/RBV fore 28 days
Drug: BI201335
48mg
Experimental
patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV fore 28 days
Drug: BI201335
120mg
Experimental
patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV fore 28 days
Drug: BI201335
240mg
Experimental
patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV fore 28 days
Drug: BI201335
Placebo
Placebo Comparator
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BI201335
Drug
patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
240mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)
Efficacy endpoint: VR (virologic response) of >=2 log10 reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients).
Baseline and up to 4 weeks
Occurrence of Adverse Events (AEs) During BI201335 + Washout Period
Occurrence of Adverse Events (AEs) during BI201335 + washout period. For placebo patients include all AEs through 30 days after trial discontinuation.
from day 1 and up to 4 weeks + 4 days washout
Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period
Occurrence of Serious Adverse Events (SAEs)during BI201335 or BI201335+ washout period. For placebo patients include all SAEs through 30 days after trial discontinuation.
from day 1 and up to 4 weeks + 4 days washout
Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time
Occurrence of laboratory test abnormalities and with respect to Division of AIDS (DAIDS) classification and laboratory test values change over time.
Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients
Maximum viral load reduction from baseline up to Day 14 for treatment-naïve patients and Day 28 treatment for treatment-experienced patients.
Baseline and up to 4 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
1a. For treatment-naïve patients: no prior therapy with interferon, peginterferon, or ribavirin for acute or chronic hepatitis C infection
1b. For treatment-experienced patients: confirmed virological failure during or after combination treatment with an approved dose of alfa-2a or alfa-2b peginterferon combined with ribavirin; such patients must have received at least 12 weeks of therapy with a 90 day washout period prior to screening and must have documentation of medical history prior to enrolment in 1220.2 2. Age 18 years or older 3. Signed informed consent form prior to trial participation 4. Male or female with documented hysterectomy or menopausal female with last menstrual period at least 6 months prior to screening 5. Chronic hepatitis C infection of genotype 1, diagnosed by positive HCV serology test (HCV Ab positive) or detectable HCV RNA at least 6 months prior to screening 6. HCV viral load >= 100,000 IU/mL at screening 7. TSH and T4 within normal limits or adequately controlled thyroid function 8. Histological evidence within 36 months prior to study enrolment of any degree of chronic necroinflammatory activity or the presence of fibrosis (Ishak Grade 1-4 or Metavir Grade 1-3)
Exclusion criteria:
Patients who have been previously treated with at least one dose of any protease inhibitor for acute or chronic hepatitis C infection
Evidence of liver disease due to causes other than chronic HCV infection
Positive ELISA for HIV-1 or HIV-2
Hepatitis B virus (HBV) infection based on presence of Hbs Ag or HBV DNA
Any previous liver biopsy consistent with cirrhosis
Decompensated liver diseases as evidenced by ascites, portal hypertension, jaundice or hepatic encephalopathy
Haemophilia
Hemoglobinopathy (e.g., thalassemia major or sickle cell anemia)
Severe pre-existing psychiatric disease
Poorly controlled diabetes mellitus
Ischaemic heart disease
Chronic obstructive airway disease
Autoimmune disease; including autoimmune hepatitis
History of alcohol abuse within the past 12 months
Hemoglobin < 12.0 g/dL for women and < 13.0 g/dL for men
White blood cell count < 2000 cells/mm3
Absolute Neutrophil Count < 1500 cells/mm3
Platelet count < 100,000 cells/mm3
Prothrombin time INR (Institutional Normalized Ratio) prolonged to > 1.5 x ULN
Usage of any investigational drug within 30 days prior to enrolment; or the planned usage of an investigational drug during the course of the current study
Known hypersensitivity to study drugs
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Boehringer Ingelheim
Boehringer Ingelheim
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
1220.2.10 Boehringer Ingelheim Investigational Site
San Francisco
California
United States
1220.2.15 Boehringer Ingelheim Investigational Site
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
FG001
Treatment Naive(TN): 20mg Per Day (QD)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
Not provided
BI201335
Drug
patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
120mg
BI201335
Drug
patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
48mg
BI201335
Drug
patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV fore 28 days
20mg
Placebo
Drug
Placebo
Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients
Change from baseline in viral load on Day 14 for treatment-naïve patients and on Day 28 treatment for treatment-experienced patients.
Baseline and up to 4 weeks
Rapid Virologic Response (RVR)
Rapid virologic response (RVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) on Day 28 for all patients.
week 4
Early Virologic Response (EVR)
Early Virologic Response (EVR): >=2 log10 reduction in plasma HCV RNA level from baseline at week 12 (day 84)
week 12
Complete EVR1 (cEVR1)
VL (Viral load) below the limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) at 4 weeks and below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at 12 weeks
week 4 and week 12
Complete EVR2 (cEVR2)
VL below the limit of detection at both 4 weeks and 12 weeks
week 4 and week 12
End of Treatment Response (ETR)
End of Treatment Response (ETR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 48 (Day 336).
week 48
Sustained Virologic Response (SVR)
Sustained Virologic Response (SVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 72 (Day 504).
week 72
Achievement of an HCV RNA Level Below the Limit of Detection Over Time
Achievement of an HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) over time
from day 1 and up to 4 weeks
Achievement of an HCV RNA Level Below the Limit of Quantification Over Time
Achievement of an HCV RNA Level Below the Limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) Over Time
from day 1 and up to 4 weeks
Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time
Achievement of a >= 2 log10 reduction in plasma HCV RNA level from baseline over time.
from day 1 and up to 4 weeks
Occurrence of AEs, by Action Taken With Regard to Study Medication
Occurrence of AEs, by action taken with regard to study medication.
from day 1 and up to 4 weeks
Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period
Occurrence of discontinuations due to AEs during BI201335 or BI201335+PegIFN/RBV combination treatment period.
from day 1 and up to 4 weeks
PK (Pharmacokinetic) Parameter After the First Dose: Cmax ( Maximum Measured Concentration of the Analyte in Plasma)
PK (pharmacokinetic) parameter after the first dose: Cmax ( Maximum measured concentration of the analyte in plasma ).
.
Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)
PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)
PK parameter after the first dose: tmax (Time from (last) dosing to the maximum measured concentration of the analyte in plasma).
Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)
PK Parameter After the First Dose: AUCÏ„,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval Ï„ on Day 1)
PK parameter after the first dose: AUCÏ„,1 (Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval Ï„ on day 1).
Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)
PK Parameter at Steady State After the Last Dose: Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval Ï„)
PK parameter at steady state after the last dose: Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval Ï„).
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
PK Parameter at Steady State After the Last Dose: Tmax,ss (Time From Last Dosing to the Maximum Measured Concentration of the Analyte in Plasma at Steady State )
PK parameter at steady state after the last dose: tmax,ss (Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state ).
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
PK Parameter at Steady State After the Last Dose: Cmin,ss (Minimum Measured Concentration of the Analyte in Plasma)
PK parameter at steady state after the last dose: Cmin,ss (Minimum measured concentration of the analyte in plasma).
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
PK Parameter at Steady State After the Last Dose: AUCÏ„,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval Ï„)
PK parameter at steady state after the last dose: AUCÏ„,ss ((Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval Ï„).
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
PK Parameter at Steady State After the Last Dose: t1/2,ss (Terminal Half-life of the Analyte in Plasma at Steady State )
PK parameter at steady state after the last dose: t1/2,ss (Terminal half-life of the analyte in plasma at steady state [h] )
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
PK Parameter at Steady State After the Last Dose: MRTpo,ss (Mean Residence Time of the Analyte in the Body at Steady State After Oral Administration)
PK parameter at steady state after the last dose: MRTpo,ss (Mean residence time of the analyte in the body at steady state after oral administration [h] )
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
PK Parameter at Steady State After the Last Dose: CL/F,ss (Apparent Clearance of the Analyte in Plasma at Steady State Following Multiple Oral Dose Administration )
PK parameter at steady state after the last dose (if applicable): CL/F,ss (ss Apparent clearance of the analyte in plasma at steady state following multiple oral dose administration [mL/min] )
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
PK Parameter at Steady State After the Last Dose: Vz/F,ss (Apparent Volume of Distribution During the Terminal Phase z at Steady State Following an Oral Administration )
PK parameter at steady state after the last dose: Vz/F,ss (Apparent volume of distribution during the terminal phase z at steady state following an oral administration [L] )
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ )
PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): AUCτ,ss ( Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ ).
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)
PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmax,ss
PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmax,ss.
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)
PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmin, ss
PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmin, ss.
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)
Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax
For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.
Day 1, Day 14, and Day 28
Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc
For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.
Day 1, Day 14, and Day 28
San Francisco
California
United States
1220.2.17 Boehringer Ingelheim Investigational Site
Baltimore
Maryland
United States
1220.2.11 Boehringer Ingelheim Investigational Site
New York
New York
United States
1220.2.12 Boehringer Ingelheim Investigational Site
New York
New York
United States
1220.2.14 Boehringer Ingelheim Investigational Site
Austin
Texas
United States
1220.2.3304A Boehringer Ingelheim Investigational Site
Lyon
France
1220.2.3303A Boehringer Ingelheim Investigational Site
Marseille
France
1220.2.3301A Boehringer Ingelheim Investigational Site
Paris
France
1220.2.3302A Boehringer Ingelheim Investigational Site
Paris
France
1220.2.49002 Boehringer Ingelheim Investigational Site
Berlin
Germany
1220.2.49005 Boehringer Ingelheim Investigational Site
Düsseldorf
Germany
1220.2.49006 Boehringer Ingelheim Investigational Site
Hanover
Germany
1220.2.49004 Boehringer Ingelheim Investigational Site
Kiel
Germany
1220.2.49003 Boehringer Ingelheim Investigational Site
Mainz
Germany
1220.2.34001 Boehringer Ingelheim Investigational Site
Madrid
Spain
Derived
Manns MP, Bourliere M, Benhamou Y, Pol S, Bonacini M, Trepo C, Wright D, Berg T, Calleja JL, White PW, Stern JO, Steinmann G, Yong CL, Kukolj G, Scherer J, Boecher WO. Potency, safety, and pharmacokinetics of the NS3/4A protease inhibitor BI201335 in patients with chronic HCV genotype-1 infection. J Hepatol. 2011 Jun;54(6):1114-22. doi: 10.1016/j.jhep.2010.08.040. Epub 2010 Nov 11.
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
FG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
FG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
FG004
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
FG006
TE Non-cirrhotic: 120 mg QD
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
FG007
TE Non-cirrhotic: 240 mg QD
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
FG008
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
FG009
TE Non-cirrhotic: 240 mg Twice a Day (BID) SGC
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
FG010
TE With Cirrhosis: 240 mg QD SGC
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
FG011
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
FG0008 subjects
FG0016 subjects
FG0027 subjects
FG0037 subjects
FG0046 subjects
FG0056 subjects
FG0067 subjects
FG0076 subjects
FG00815 subjects
FG00915 subjects
FG0106 subjects
FG0117 subjects
COMPLETED
FG0008 subjects
FG0015 subjects
FG0025 subjects
FG0034 subjects
FG0044 subjects
FG0054 subjects
FG0063 subjects
FG0076 subjects
FG0086 subjects
FG0096 subjects
FG0103 subjects
FG0111 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG0042 subjects
FG0052 subjects
FG0064 subjects
FG0070 subjects
FG0089 subjects
FG0099 subjects
FG0103 subjects
FG0116 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0112 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
reason not specified
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Full Analysis Set (FAS): All randomized patients who were dispensed trial medication and were documented to have taken at least 1 dose of trial medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Treatment Naive (TN): Placebo
TN patient to receive Placebo + PegIFN/RBV for 28 days
BG001
TN: 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
BG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
BG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
BG004
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
BG006
TE Non-cirrhotic: 120 mg QD
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
BG007
TE Non-cirrhotic: 240 mg QD
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
BG008
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
BG009
TE Non-cirrhotic: 240 mg BID SGC
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
BG010
TE With Cirrhosis: 240 mg QD SGC
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
BG011
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0016
BG0027
BG0037
BG0046
BG0056
BG0067
BG0076
BG00815
BG00915
BG0106
BG0117
BG01296
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00049.88± 8.36
BG00151.00± 7.97
BG00247.14± 13.84
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0010
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
Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)
Efficacy endpoint: VR (virologic response) of >=2 log10 reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients).
Full Analysis Set (FAS): All randomized TN patients and treatment experienced patients who were dispensed trial medication and were documented to have taken at least 1 dose of trial medication.
Posted
Number
95% Confidence Interval
percentage of responders
Baseline and up to 4 weeks
ID
Title
Description
OG000
TN: Placebo
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
OG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG004
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG006
TE Non-cirrhotic: 120 mg QD
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG007
TE Non-cirrhotic: 240 mg QD
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG008
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
OG009
TE Non-cirrhotic: 240 mg BID SGC
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
OG010
TE With Cirrhosis: 240 mg QD SGC
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
OG011
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Units
Counts
Participants
OG0008
OG0016
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.00(0.000 to 33.627)
OG00183.33(42.128 to 96.331)
OG002100.00(63.058 to 100.000)
OG003
Primary
Occurrence of Adverse Events (AEs) During BI201335 + Washout Period
Occurrence of Adverse Events (AEs) during BI201335 + washout period. For placebo patients include all AEs through 30 days after trial discontinuation.
Treated Set (TS): This patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment regardless of randomization.
Posted
Number
percentage of participants with AEs
from day 1 and up to 4 weeks + 4 days washout
ID
Title
Description
OG000
TN: Placebo
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
OG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Primary
Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period
Occurrence of Serious Adverse Events (SAEs)during BI201335 or BI201335+ washout period. For placebo patients include all SAEs through 30 days after trial discontinuation.
TS
Posted
Number
percentage of participants with SAEs
from day 1 and up to 4 weeks + 4 days washout
ID
Title
Description
OG000
TN: Placebo
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
OG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG004
TN: 240mg QD
Primary
Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time
Occurrence of laboratory test abnormalities and with respect to Division of AIDS (DAIDS) classification and laboratory test values change over time.
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
OG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients
Maximum viral load reduction from baseline up to Day 14 for treatment-naïve patients and Day 28 treatment for treatment-experienced patients.
FAS (as randomised)
Posted
Median
Inter-Quartile Range
log10 IU/mL
Baseline and up to 4 weeks
ID
Title
Description
OG000
TN: Placebo
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
OG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG004
Secondary
Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients
Change from baseline in viral load on Day 14 for treatment-naïve patients and on Day 28 treatment for treatment-experienced patients.
FAS (as randomised) including patients with available viral load data.
Posted
Median
Inter-Quartile Range
Log10 IU/mL
Baseline and up to 4 weeks
ID
Title
Description
OG000
Treatment Naive (TN): Placebo
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
OG001
Treatment Naive(TN): 20mg Per Day (QD)
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
Rapid Virologic Response (RVR)
Rapid virologic response (RVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) on Day 28 for all patients.
FAS (as randomized)
Posted
Number
95% Confidence Interval
percentage of responders
week 4
ID
Title
Description
OG000
TN: Placebo
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
OG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG004
TN: 240mg QD
Secondary
Early Virologic Response (EVR)
Early Virologic Response (EVR): >=2 log10 reduction in plasma HCV RNA level from baseline at week 12 (day 84)
FAS
Posted
Number
percentage of responders
week 12
ID
Title
Description
OG000
TN: Placebo
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
OG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG004
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
Complete EVR1 (cEVR1)
VL (Viral load) below the limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) at 4 weeks and below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at 12 weeks
FAS
Posted
Number
percentage of responders
week 4 and week 12
ID
Title
Description
OG000
Treatment Naive (TN): Placebo
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
OG001
Treatment Naive(TN): 20mg Per Day (QD)
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG004
Secondary
Complete EVR2 (cEVR2)
VL below the limit of detection at both 4 weeks and 12 weeks
FAS
Posted
Number
percentage of responders
week 4 and week 12
ID
Title
Description
OG000
Treatment Naive (TN): Placebo
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
OG001
Treatment Naive(TN): 20mg Per Day (QD)
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG004
TN: 240mg QD
Secondary
End of Treatment Response (ETR)
End of Treatment Response (ETR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 48 (Day 336).
FAS
Posted
Number
percentage of responders
week 48
ID
Title
Description
OG000
TN: Placebo
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
OG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG004
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
Sustained Virologic Response (SVR)
Sustained Virologic Response (SVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 72 (Day 504).
FAS
Posted
Number
percentage of responders
week 72
ID
Title
Description
OG000
TN: Placebo
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
OG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG004
TN: 240mg QD
Secondary
Achievement of an HCV RNA Level Below the Limit of Detection Over Time
Achievement of an HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) over time
FAS
Posted
Number
percentage of participants
from day 1 and up to 4 weeks
ID
Title
Description
OG000
TN: Placebo
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
OG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG004
TN: 240mg QD
Secondary
Achievement of an HCV RNA Level Below the Limit of Quantification Over Time
Achievement of an HCV RNA Level Below the Limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) Over Time
FAS
Posted
Number
percentage of participants
from day 1 and up to 4 weeks
ID
Title
Description
OG000
TN: Placebo
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
OG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG004
TN: 240mg QD
Secondary
Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time
Achievement of a >= 2 log10 reduction in plasma HCV RNA level from baseline over time.
FAS
Posted
Number
percentage of participants
from day 1 and up to 4 weeks
ID
Title
Description
OG000
TN: Placebo
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
OG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG004
TN: 240mg QD
Secondary
Occurrence of AEs, by Action Taken With Regard to Study Medication
Occurrence of AEs, by action taken with regard to study medication.
TS
Posted
Number
percentage of participants
from day 1 and up to 4 weeks
ID
Title
Description
OG000
Treatment Naive (TN): Placebo
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
OG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG004
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period
Occurrence of discontinuations due to AEs during BI201335 or BI201335+PegIFN/RBV combination treatment period.
TS
Posted
Number
percentage of participants discontinued
from day 1 and up to 4 weeks
ID
Title
Description
OG000
TN: Placebo
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
OG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG004
TN: 240mg QD
Secondary
PK (Pharmacokinetic) Parameter After the First Dose: Cmax ( Maximum Measured Concentration of the Analyte in Plasma)
PK (pharmacokinetic) parameter after the first dose: Cmax ( Maximum measured concentration of the analyte in plasma ).
.
TS
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)
ID
Title
Description
OG000
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)
PK parameter after the first dose: tmax (Time from (last) dosing to the maximum measured concentration of the analyte in plasma).
TS
Posted
Geometric Mean
Geometric Coefficient of Variation
h
Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)
ID
Title
Description
OG000
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
PK Parameter After the First Dose: AUCÏ„,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval Ï„ on Day 1)
PK parameter after the first dose: AUCÏ„,1 (Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval Ï„ on day 1).
TS
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)
ID
Title
Description
OG000
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
PK Parameter at Steady State After the Last Dose: Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval Ï„)
PK parameter at steady state after the last dose: Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval Ï„).
TS including patients with available Cmax,ss data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
ID
Title
Description
OG000
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
Secondary
PK Parameter at Steady State After the Last Dose: Tmax,ss (Time From Last Dosing to the Maximum Measured Concentration of the Analyte in Plasma at Steady State )
PK parameter at steady state after the last dose: tmax,ss (Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state ).
TS including patients with available tmax,ss data
Posted
Geometric Mean
Geometric Coefficient of Variation
h
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
ID
Title
Description
OG000
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
PK Parameter at Steady State After the Last Dose: Cmin,ss (Minimum Measured Concentration of the Analyte in Plasma)
PK parameter at steady state after the last dose: Cmin,ss (Minimum measured concentration of the analyte in plasma).
TS including patients with available Cmin,ss data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
ID
Title
Description
OG000
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
PK Parameter at Steady State After the Last Dose: AUCÏ„,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval Ï„)
PK parameter at steady state after the last dose: AUCÏ„,ss ((Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval Ï„).
TS including patients with available AUCÏ„,ss data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
ID
Title
Description
OG000
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
Secondary
PK Parameter at Steady State After the Last Dose: t1/2,ss (Terminal Half-life of the Analyte in Plasma at Steady State )
PK parameter at steady state after the last dose: t1/2,ss (Terminal half-life of the analyte in plasma at steady state [h] )
TS including patients with available t1/2,ss data
Posted
Geometric Mean
Geometric Coefficient of Variation
h
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
ID
Title
Description
OG000
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
PK Parameter at Steady State After the Last Dose: MRTpo,ss (Mean Residence Time of the Analyte in the Body at Steady State After Oral Administration)
PK parameter at steady state after the last dose: MRTpo,ss (Mean residence time of the analyte in the body at steady state after oral administration [h] )
TS including patients with available MRTpo,ss data
Posted
Geometric Mean
Geometric Coefficient of Variation
h
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
ID
Title
Description
OG000
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
PK Parameter at Steady State After the Last Dose: CL/F,ss (Apparent Clearance of the Analyte in Plasma at Steady State Following Multiple Oral Dose Administration )
PK parameter at steady state after the last dose (if applicable): CL/F,ss (ss Apparent clearance of the analyte in plasma at steady state following multiple oral dose administration [mL/min] )
TS including patients with available CL/F,ss data
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/min
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
ID
Title
Description
OG000
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
Secondary
PK Parameter at Steady State After the Last Dose: Vz/F,ss (Apparent Volume of Distribution During the Terminal Phase z at Steady State Following an Oral Administration )
PK parameter at steady state after the last dose: Vz/F,ss (Apparent volume of distribution during the terminal phase z at steady state following an oral administration [L] )
TS including patients with available Vz/F,ss data
Posted
Geometric Mean
Geometric Coefficient of Variation
L
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
ID
Title
Description
OG000
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
Secondary
PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ )
PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): AUCτ,ss ( Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ ).
TS (for TN patients only)
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)
ID
Title
Description
OG000
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
Secondary
PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmax,ss
PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmax,ss.
TS (for TN patients only)
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)
ID
Title
Description
OG000
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmin, ss
PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmin, ss.
TS (for TN patients only)
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)
ID
Title
Description
OG000
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax
For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.
TS including patients with available RAcmax data
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Day 1, Day 14, and Day 28
ID
Title
Description
OG000
Treatment Naive(TN): 20mg Per Day (QD)
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Secondary
Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc
For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.
TS including patients with available RAauc data
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Day 1, Day 14, and Day 28
ID
Title
Description
OG000
Treatment Naive(TN): 20mg Per Day (QD)
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
OG001
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG002
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
OG003
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Time Frame
day 1 and up to 4 weeks + washout
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
Treatment Naive (TN): Placebo
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
0
8
5
8
EG001
Treatment Naive(TN): 20mg QD
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
1
6
6
6
EG002
TN: 48mg QD
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1
7
7
7
EG003
TN: 120mg QD
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
0
7
4
7
EG004
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
0
6
6
6
EG006
TE Non-cirrhotic: 120 mg QD
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
0
7
7
7
EG007
TE Non-cirrhotic: 240 mg QD
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
0
6
6
6
EG008
TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
0
15
15
15
EG009
TE Non-cirrhotic: 240 mg BID SGC
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
0
15
15
15
EG010
TE With Cirrhosis: 240 mg QD SGC
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
0
6
6
6
EG011
TE With Cirrhosis: 240 mg BID SGC
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
2
7
7
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cataract
Eye disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG0030 affected7 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0080 affected15 at risk
EG0090 affected15 at risk
EG0100 affected6 at risk
EG0110 affected7 at risk
Ascites
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Asthenia
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Metabolic disorder
Metabolism and nutrition disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG0030 affected7 at risk
EG0041 affected6 at risk
EG0051 affected6 at risk
EG0060 affected7 at risk
EG0070 affected6 at risk
EG0083 affected15 at risk
EG0092 affected15 at risk
EG0100 affected6 at risk
EG0110 affected7 at risk
Neutropenia
Blood and lymphatic system disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Arrhythmia
Cardiac disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Palpitations
Cardiac disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Vertigo
Ear and labyrinth disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Abnormal sensation in eye
Eye disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Conjunctivitis
Eye disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dry eye
Eye disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Erythema of eyelid
Eye disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Eyelids pruritus
Eye disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Ocular icterus
Eye disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Photophobia
Eye disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Vision blurred
Eye disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Visual impairment
Eye disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Anal pruritus
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cheilitis
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Colitis
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0022 affected7 at risk
EG003
Dry mouth
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0021 affected7 at risk
EG003
Flatulence
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0021 affected7 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Lip dry
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0002 affected8 at risk
EG0011 affected6 at risk
EG0023 affected7 at risk
EG003
Periodontitis
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Stomatitis
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Asthenia
General disorders
MEDDRA 13.1
Systematic Assessment
EG0002 affected8 at risk
EG0013 affected6 at risk
EG0023 affected7 at risk
EG003
Chest pain
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Chills
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Exercise tolerance decreased
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Fatigue
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0021 affected7 at risk
EG003
Feeling abnormal
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Feeling cold
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Hyperthermia
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0013 affected6 at risk
EG0020 affected7 at risk
EG003
Influenza like illness
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected6 at risk
EG0020 affected7 at risk
EG003
Injection site erythema
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Injection site pruritus
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Injection site rash
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Injection site reaction
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Irritability
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0023 affected7 at risk
EG003
Mucosal dryness
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Mucosal ulceration
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Oedema peripheral
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pain
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pyrexia
General disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Jaundice
Hepatobiliary disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Bronchitis
Infections and infestations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Gastroenteritis
Infections and infestations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Gingival abscess
Infections and infestations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Herpes simplex
Infections and infestations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Herpes virus infection
Infections and infestations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Influenza
Infections and infestations
MEDDRA 13.1
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected6 at risk
EG0023 affected7 at risk
EG003
Nasopharyngitis
Infections and infestations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Oral herpes
Infections and infestations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Rhinitis
Infections and infestations
MEDDRA 13.1
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Sinusitis
Infections and infestations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Tonsillitis
Infections and infestations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Tooth abscess
Infections and infestations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Scratch
Injury, poisoning and procedural complications
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Blood bilirubin increased
Investigations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Body temperature increased
Investigations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Breath sounds abnormal
Investigations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cardiac murmur
Investigations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Haemoglobin decreased
Investigations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Weight decreased
Investigations
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected6 at risk
EG0022 affected7 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected6 at risk
EG0021 affected7 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Amnesia
Nervous system disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Disturbance in attention
Nervous system disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dizziness
Nervous system disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Headache
Nervous system disorders
MEDDRA 13.1
Systematic Assessment
EG0002 affected8 at risk
EG0011 affected6 at risk
EG0022 affected7 at risk
EG003
Memory impairment
Nervous system disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Migraine
Nervous system disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Paraesthesia
Nervous system disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Somnolence
Nervous system disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Syncope
Nervous system disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Tremor
Nervous system disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Affect lability
Psychiatric disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Aggression
Psychiatric disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Agitation
Psychiatric disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Anxiety
Psychiatric disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Depressed mood
Psychiatric disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Depression
Psychiatric disorders
MEDDRA 13.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Insomnia
Psychiatric disorders
MEDDRA 13.1
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected6 at risk
EG0022 affected7 at risk
EG003
Mood altered
Psychiatric disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Mood swings
Psychiatric disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Chromaturia
Renal and urinary disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pollakiuria
Renal and urinary disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Renal pain
Renal and urinary disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Urine odour abnormal
Renal and urinary disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MEDDRA 13.1
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Larynx irritation
Respiratory, thoracic and mediastinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected6 at risk
EG0022 affected7 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0022 affected7 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Photosensitivity allergic reaction
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0021 affected7 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Skin reaction
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected6 at risk
EG0020 affected7 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Dental implantation
Surgical and medical procedures
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Haematoma
Vascular disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Hot flush
Vascular disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0020 affected7 at risk
EG003
Hypertension
Vascular disorders
MEDDRA 13.1
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected6 at risk
EG0021 affected7 at risk
EG003
Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab "Full Text Review", section "More Information".
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Boehringer Ingelheim Call Center
Boehringer Ingelheim
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
ID
Term
D019698
Hepatitis C, Chronic
Ancestor Terms
ID
Term
D006526
Hepatitis C
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D006525
Hepatitis, Viral, Human
D014777
Virus Diseases
D018178
Flaviviridae Infections
D012327
RNA Virus Infections
D006521
Hepatitis, Chronic
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C552340
faldaprevir
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0093 subjects
FG0101 subjects
FG0110 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
1 subjects
FG0051 subjects
FG0062 subjects
FG0070 subjects
FG0087 subjects
FG0096 subjects
FG0102 subjects
FG0114 subjects
48.57
± 16.31
BG00447.83± 9.26
BG00546.83± 11.82
BG00646.71± 4.79
BG00749.33± 10.11
BG00850.93± 8.13
BG00948.93± 13.10
BG01053.67± 5.32
BG01153.57± 8.36
BG01249.59± 10.08
2
BG0032
BG0041
BG0052
BG0063
BG0073
BG0085
BG0097
BG0101
BG0112
BG01230
Male
BG0006
BG0016
BG0025
BG0035
BG0045
BG0054
BG0064
BG0073
BG00810
BG0098
BG0105
BG0115
BG01266
7
OG0046
OG0056
OG0067
OG0076
OG00815
OG00915
OG0106
OG0117
100.00
(63.058 to 100.000)
OG004100.00(59.038 to 100.000)
OG005100.00(59.038 to 100.000)
OG006100.00(63.058 to 100.000)
OG007100.00(59.038 to 100.000)
OG008100.00(79.409 to 100.000)
OG009100.00(79.409 to 100.000)
OG010100.00(59.038 to 100.000)
OG011100.00(63.058 to 100.000)
OG004
TN: 240mg QD
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days