Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00774397
Registration number
NCT00774397
Ethics application status
Date submitted
16/10/2008
Date registered
17/10/2008
Date last updated
16/11/2015
Titles & IDs
Public title
Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)
Query!
Scientific title
Antiviral Effect, Safety and Pharmacokinetics of BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naïve and Treatment-experienced Patients for 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Double-blinded, Randomised, Placebo-controlled, Phase II)
Query!
Secondary ID [1]
0
0
2008-003538-11
Query!
Secondary ID [2]
0
0
1220.5
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - BI 201335 NA 240 mg QD / LI
Treatment: Drugs - PegIFN/RBV
Treatment: Drugs - BI 201335 NA 120mg QD / LI
Treatment: Drugs - PegIFN/RBV
Treatment: Drugs - BI 201335 NA 240 mg QD
Treatment: Drugs - PegIFN/RBV
Treatment: Drugs - BI 201335 NA 240 mg QD
Treatment: Drugs - PegIFN/RBV
Treatment: Drugs - BI 201335 NA 240 mg BID
Treatment: Drugs - PegIFN/RBV
Treatment: Drugs - PegIFN/RBV
Treatment: Drugs - BI 201335 NA 240 mg QD
Treatment: Drugs - PegIFN/RBV
Treatment: Drugs - Placebo
Experimental: 240 mg QD TN - 240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
Experimental: 240 mg QD / LI-TN - 240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
Placebo Comparator: Placebo - Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
Experimental: 120 mg QD / LI-TN - 120 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients
Experimental: 240 mg QD TE - 240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients
Experimental: 240 mg QD / LI-TE - 240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients
Experimental: 240 mg BID / LI-TE - 240mg BI 201335 NA (Faldaprevir) twice daily combined with PegIFN/RBV for 24 or 48 weeks, with 3-day lead-in phase of PegIFN/RBV, in treatment-experienced patients
Treatment: Drugs: BI 201335 NA 240 mg QD / LI
240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks
Treatment: Drugs: PegIFN/RBV
PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks
Treatment: Drugs: BI 201335 NA 120mg QD / LI
120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks
Treatment: Drugs: PegIFN/RBV
PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
Treatment: Drugs: BI 201335 NA 240 mg QD
240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks
Treatment: Drugs: PegIFN/RBV
PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
Treatment: Drugs: BI 201335 NA 240 mg QD
240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks
Treatment: Drugs: PegIFN/RBV
PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks
Treatment: Drugs: BI 201335 NA 240 mg BID
240mg BI 201335 NA (Faldaprevir) twice, 24 weeks
Treatment: Drugs: PegIFN/RBV
PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
Treatment: Drugs: PegIFN/RBV
PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
Treatment: Drugs: BI 201335 NA 240 mg QD
240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks
Treatment: Drugs: PegIFN/RBV
PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks
Treatment: Drugs: Placebo
Placebo
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo
Query!
Assessment method [1]
0
0
An achieved virological response is defined as the plasma Hepatitis C Virus RiboNucleic Acid (HCV RNA) level below the lower limit of detection (BLD).
This data was only collected for patients, who stopped trial participation at Week 24 and did not continue with PegIFN/RBV until Week 48.
The lower limit of quantification (BLQ) of this assay was 25 IU/mL and the lower limit of detection (BLD) was 10 IU/mL at the time of the protocol finalisation. During the course of the trial, the manufacturer defined BLD as '< 25 IU/mL, not detectable' and BLQ as '< 25 IU/mL, detectable'.
Query!
Timepoint [1]
0
0
Week 28
Query!
Primary outcome [2]
0
0
Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy
Query!
Assessment method [2]
0
0
Virological (VL) response was defined as the plasma HCV RNA level below the lower limit of detection.
The first VL measurement that occurred in the time window = Day 155 (from End Of Treatment on) was selected for the determination of SVR24.
Therefore, patients with virological load BLD 24 weeks after completion of therapy, who had a rebound after this time point (outside the defined time window of 155 days after end of all treatments) were identified as SVR24 achieved.
Query!
Timepoint [2]
0
0
Day 155 after the end of all treatment
Query!
Secondary outcome [1]
0
0
Virological Response at Week 2
Query!
Assessment method [1]
0
0
Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 2 (< 25 IU/ml, detectable or undetectable)
Query!
Timepoint [1]
0
0
Week 2
Query!
Secondary outcome [2]
0
0
Virological Response at Week 4
Query!
Assessment method [2]
0
0
Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 4 (< 25 IU/ml, detectable or undetectable)
Query!
Timepoint [2]
0
0
Week 4
Query!
Secondary outcome [3]
0
0
Early Virological Response (EVR)
Query!
Assessment method [3]
0
0
Early Virological Response (EVR) is defined as = 2 log 10 reduction in plasma HCV RNA level from baseline at Week 12
Query!
Timepoint [3]
0
0
Baseline and Week 12
Query!
Secondary outcome [4]
0
0
Extended Rapid Virological Response (eRVR)
Query!
Assessment method [4]
0
0
Extended Rapid Virological Response (eRVR) is defined as plasma HCV RNA levels below the lower limit of quantification at Week 4 and below the lower limit of detection at Week 12
Query!
Timepoint [4]
0
0
Week 4 and Week 12
Query!
Secondary outcome [5]
0
0
Complete Early Virological Response (cEVR)
Query!
Assessment method [5]
0
0
Complete Early Virological Response (cEVR) is defined as plasma HCV RNA level below the lower limit of detection at Week 12
Query!
Timepoint [5]
0
0
Week 12
Query!
Secondary outcome [6]
0
0
End of Treatment Response at Week 24
Query!
Assessment method [6]
0
0
End of Treatment Response of BI 201335 or placebo (ETR BI 201335/placebo ) is defined as plasma HCV RNA level below the lower limit of detection at Week 24.
Query!
Timepoint [6]
0
0
Week 24
Query!
Secondary outcome [7]
0
0
End of Treatment Response at End of All Therapy
Query!
Assessment method [7]
0
0
End of Treatment Response (ETR) is defined as plasma HCV RNA level below the lower limit of detection at end of all therapy, i.e. at Week 24 or Week 48
Query!
Timepoint [7]
0
0
Week 24 or Week 48
Query!
Secondary outcome [8]
0
0
Sustained Virological Response 12 Weeks (SVR12) After Completion of All Therapy
Query!
Assessment method [8]
0
0
Sustained Virological Response 12 Weeks (SVR12) after completion of all therapy is defined as plasma HCV RNA level below the lower limit of detection at 12 weeks after completion of all therapy, i.e. at Week 36 or 60
Query!
Timepoint [8]
0
0
Week 36 or Week 60
Query!
Secondary outcome [9]
0
0
Time to Reach a Plasma HCV RNA Level Below the Lower Limit of Detection
Query!
Assessment method [9]
0
0
Summary of time (i.e Median number of days) to reach a plasma HCV RNA level below limit of detection (BLD)
Query!
Timepoint [9]
0
0
On or after day 155 post end of all treatment
Query!
Secondary outcome [10]
0
0
Time to Loss of Virological Response
Query!
Assessment method [10]
0
0
Time to loss of virological response, defined as the last value below the lower limit of detection in a patient who subsequently had 2 consecutive plasma HCV RNA level measurements =100 IU/mL. Patients that did not achieve suppression of plasma HCV RNA levels below the lower limit of detection until Week 24 were defined as having a time to failure of zero.
Time is expressed in Median number of days.
Query!
Timepoint [10]
0
0
Week 24
Query!
Secondary outcome [11]
0
0
Virological Rebound
Query!
Assessment method [11]
0
0
Virological rebound is defined as increase of = 1 log 10 in plasma HCV RNA level from a quantifiable nadir, or to = 250 IU/mL after previous nadir < 25 IU/mL (detectable), or to = 100 IU/mL after a previous viral load below the lower limit of detection.
Note that this is numerical rebound, not requiring confirmation with a re-measurement.
Query!
Timepoint [11]
0
0
Week 24 or Week 48
Query!
Secondary outcome [12]
0
0
Breakthrough on BI 201335/Placebo (Rebound While All 3 Treatments Were Still Ongoing)
Query!
Assessment method [12]
0
0
Number of patients with Unconfirmed rebound ( = 1log10 increase in HCV mRNA) while on BI201335/placebo + 5 days washout.
Query!
Timepoint [12]
0
0
Up to Week 24
Query!
Secondary outcome [13]
0
0
Breakthrough on PegIFN/RBV (Rebound While Only PegIFN/RBV Treatment Alone Was Still Ongoing)
Query!
Assessment method [13]
0
0
Number of patients with Unconfirmed rebound (= 1log10 increase in HCV mRNA) while on PegIFN/RBV treatment + 5 days washout.
Query!
Timepoint [13]
0
0
Week 24 through Week 48
Query!
Secondary outcome [14]
0
0
Relapse
Query!
Assessment method [14]
0
0
Relapse was rebound after the viral load at end of all treatment had been below the lower limit of detection, or, if the value at end of all treatment was missing, after both the last value before End of Treatment (EOT) and the first value after End of Treatment were below the lower limit of detection.
Patients could experience relapse at any point post-treatment.
Query!
Timepoint [14]
0
0
post-End of treatment (i.e. post 48 weeks)
Query!
Secondary outcome [15]
0
0
Change From Baseline to Week 24 in Diastolic Blood Pressure and Systolic Blood Pressure
Query!
Assessment method [15]
0
0
Baseline is defined as the last value before the initial drug administration of BI 201335 or placebo.
Query!
Timepoint [15]
0
0
Baseline and Week 24
Query!
Secondary outcome [16]
0
0
Change From Baseline to Week 24 in Pulse Rate
Query!
Assessment method [16]
0
0
Baseline is defined as the last value before the administration of BI 201335 or placebo.
Query!
Timepoint [16]
0
0
Baseline and Week 24
Query!
Secondary outcome [17]
0
0
Change From Baseline to Week 24 in Weight of the Patients
Query!
Assessment method [17]
0
0
Baseline is defined as the last value before the administration of BI 201335 or placebo.
Query!
Timepoint [17]
0
0
Baseline and Week 24
Query!
Secondary outcome [18]
0
0
Global Assessment of Tolerability
Query!
Assessment method [18]
0
0
The investigator was to assess the tolerability of trial medication based on adverse events (AEs) and the laboratory evaluation.
Tolerability was assessed by the investigator according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.
Query!
Timepoint [18]
0
0
Week 24
Query!
Secondary outcome [19]
0
0
Change From Baseline to Week 24 in Haemoglobin of the Patients
Query!
Assessment method [19]
0
0
Baseline is defined as the last value before the administration of BI 201335 or placebo.
Query!
Timepoint [19]
0
0
Baseline and Week 24
Query!
Secondary outcome [20]
0
0
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Haemoglobin
Query!
Assessment method [20]
0
0
Number of patients with normal or high baseline moved to low .
Query!
Timepoint [20]
0
0
Baseline and Week 24
Query!
Secondary outcome [21]
0
0
Change From Baseline to Week 24 in Absolute Neutrophils of the Patients
Query!
Assessment method [21]
0
0
Baseline is defined as the last value before the administration of BI 201335 or placebo.
Query!
Timepoint [21]
0
0
Baseline and Week 24
Query!
Secondary outcome [22]
0
0
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Absolute Neutrophils
Query!
Assessment method [22]
0
0
Number of patients with normal or high baseline moved to low .
Query!
Timepoint [22]
0
0
Baseline and Week 24
Query!
Secondary outcome [23]
0
0
Change From Baseline to Week 24 in ALT/GPT,SGPT of the Patients
Query!
Assessment method [23]
0
0
Baseline is defined as the last value before the drug administration of BI 201335 or placebo.
Query!
Timepoint [23]
0
0
Baseline and Week 24
Query!
Secondary outcome [24]
0
0
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter ALT/GPT,SGPT
Query!
Assessment method [24]
0
0
Number of patients with normal or low baseline moved to high .
Query!
Timepoint [24]
0
0
Baseline and Week 24
Query!
Secondary outcome [25]
0
0
Change From Baseline to Week 24 in Total Bilirubin of the Patients
Query!
Assessment method [25]
0
0
Baseline is defined as the last value before the administration of BI 201335 or placebo.
Query!
Timepoint [25]
0
0
Baseline and Week 24
Query!
Secondary outcome [26]
0
0
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Total Bilirubin
Query!
Assessment method [26]
0
0
Number of patients with normal or low baseline moved to high .
Query!
Timepoint [26]
0
0
Baseline and Week 24
Query!
Secondary outcome [27]
0
0
Trough Concentration (Cpre,ss) of Faldaprevir at Steady State
Query!
Assessment method [27]
0
0
C(pre,ss) is defined as pre-dose (trough) concentration of Faldaprevir in plasma at steady state immediately before administration of the next dose.
Query!
Timepoint [27]
0
0
Week 8, week 10, week 12, week 24
Query!
Secondary outcome [28]
0
0
Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV)
Query!
Assessment method [28]
0
0
C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.
Query!
Timepoint [28]
0
0
Week 8, week 10, week 12, week 24
Query!
Secondary outcome [29]
0
0
Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV)
Query!
Assessment method [29]
0
0
C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.
Query!
Timepoint [29]
0
0
Week 8, week 10, week 12, week 24
Query!
Secondary outcome [30]
0
0
Trough Concentration (Cpre,ss) of PegIFN at Steady State
Query!
Assessment method [30]
0
0
C(pre,ss) is defined as pre-dose (trough) concentration of PegIFN in plasma at steady state immediately before administration of the next dose.
Query!
Timepoint [30]
0
0
Week 8, week 10, week 12, week 24
Query!
Eligibility
Key inclusion criteria
Inclusion criteria:
chronic HCV GT1; therapy-naive to IFN, PegIFN, or RBV; HCV VL >=100,000 IU/mL Liver biopsy
within 2 years prior to study enrolment showing necroinflammatory activity or presence of
fibrosis Normal retinal finding on fundoscopy within 6 months prior to Day 1 age 18-65
years Females and males with adequate contraception
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion criteria:
Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening Previous
treatment with protease inhibitor Evidence of liver disease due to causes other than
chronic HCV infection HIV-1 or HIV-2 positive HBV positive Decompensated liver disease, or
history of decompensated liver disease Active or suspected malignancy or history of
malignancy within the last 5 years History of alcohol or drug abuse within the past 12
months. Usage of any investigational drug within 30 days prior to enrolment, or 5
half-lives, whichever is longer Known hypersensitivity to any ingredient of the study drugs
Condition that is defined as one which in the opinion of the investigator may put the
patient at risk because of participation in the study or may influence the results of the
study or the patient's ability to participate in the study Alpha-fetoprotein value >
100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no
evidence of liver cancer in two congruent imaging studies Total bilirubin > 1.5x ULN wiht
ratio of direct/indirect >1. ALT or AST levels > 5x ULN INR prolonged to >1.5x ULN
Exclusion criteria related to PegIFN and/or RBV restrictions.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/10/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
719
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
1220.5.6110 Boehringer Ingelheim Investigational Site - Camperdown
Query!
Recruitment hospital [2]
0
0
1220.5.6109 Boehringer Ingelheim Investigational Site - Kogarah
Query!
Recruitment hospital [3]
0
0
1220.5.6105 Boehringer Ingelheim Investigational Site - Randwick
Query!
Recruitment hospital [4]
0
0
1220.5.6101 Boehringer Ingelheim Investigational Site - Westmead
Query!
Recruitment hospital [5]
0
0
1220.5.6103 Boehringer Ingelheim Investigational Site - Herston
Query!
Recruitment hospital [6]
0
0
1220.5.6104 Boehringer Ingelheim Investigational Site - Woolloongabba
Query!
Recruitment hospital [7]
0
0
1220.5.6102 Boehringer Ingelheim Investigational Site - Clayton
Query!
Recruitment hospital [8]
0
0
1220.5.6107 Boehringer Ingelheim Investigational Site - Fitzroy
Query!
Recruitment hospital [9]
0
0
1220.5.6108 Boehringer Ingelheim Investigational Site - Parkville
Query!
Recruitment postcode(s) [1]
0
0
- Camperdown
Query!
Recruitment postcode(s) [2]
0
0
- Kogarah
Query!
Recruitment postcode(s) [3]
0
0
- Randwick
Query!
Recruitment postcode(s) [4]
0
0
- Westmead
Query!
Recruitment postcode(s) [5]
0
0
- Herston
Query!
Recruitment postcode(s) [6]
0
0
- Woolloongabba
Query!
Recruitment postcode(s) [7]
0
0
- Clayton
Query!
Recruitment postcode(s) [8]
0
0
- Fitzroy
Query!
Recruitment postcode(s) [9]
0
0
- Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Illinois
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Maryland
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
New York
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Pennsylvania
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Tennessee
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Texas
Query!
Country [8]
0
0
Argentina
Query!
State/province [8]
0
0
Capital Federal
Query!
Country [9]
0
0
Argentina
Query!
State/province [9]
0
0
Derqui, Pilar
Query!
Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
Rosario
Query!
Country [11]
0
0
Austria
Query!
State/province [11]
0
0
Linz
Query!
Country [12]
0
0
Austria
Query!
State/province [12]
0
0
Wien
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Alberta
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
British Columbia
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Ontario
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Quebec
Query!
Country [17]
0
0
Czech Republic
Query!
State/province [17]
0
0
Melnik
Query!
Country [18]
0
0
Czech Republic
Query!
State/province [18]
0
0
Opava
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Clichy
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Creteil
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Lyon
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Marseille
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Montpellier
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Paris Cedex 20
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Paris
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Vandoeuvre Cedex
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Berlin
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Bochum
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Bonn
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Dortmund
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Düsseldorf
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Frankfurt/Main
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Hamburg
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Hannover
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Leipzig
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Mainz
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Tübingen
Query!
Country [38]
0
0
Korea, Republic of
Query!
State/province [38]
0
0
Busan
Query!
Country [39]
0
0
Korea, Republic of
Query!
State/province [39]
0
0
Daegu
Query!
Country [40]
0
0
Korea, Republic of
Query!
State/province [40]
0
0
Pusan
Query!
Country [41]
0
0
Korea, Republic of
Query!
State/province [41]
0
0
Seoul
Query!
Country [42]
0
0
Korea, Republic of
Query!
State/province [42]
0
0
Seoungnam
Query!
Country [43]
0
0
Korea, Republic of
Query!
State/province [43]
0
0
Sungnam
Query!
Country [44]
0
0
Korea, Republic of
Query!
State/province [44]
0
0
Suwon
Query!
Country [45]
0
0
Korea, Republic of
Query!
State/province [45]
0
0
Yangsan
Query!
Country [46]
0
0
Netherlands
Query!
State/province [46]
0
0
Amsterdam
Query!
Country [47]
0
0
Netherlands
Query!
State/province [47]
0
0
Leiden
Query!
Country [48]
0
0
Portugal
Query!
State/province [48]
0
0
Coimbra
Query!
Country [49]
0
0
Portugal
Query!
State/province [49]
0
0
Lisboa
Query!
Country [50]
0
0
Portugal
Query!
State/province [50]
0
0
Porto
Query!
Country [51]
0
0
Romania
Query!
State/province [51]
0
0
Bucharest
Query!
Country [52]
0
0
Spain
Query!
State/province [52]
0
0
Barcelona
Query!
Country [53]
0
0
Spain
Query!
State/province [53]
0
0
Madrid
Query!
Country [54]
0
0
Switzerland
Query!
State/province [54]
0
0
Bern
Query!
Country [55]
0
0
Switzerland
Query!
State/province [55]
0
0
La Chaux-de-Fonds
Query!
Country [56]
0
0
Switzerland
Query!
State/province [56]
0
0
Lugano
Query!
Country [57]
0
0
Switzerland
Query!
State/province [57]
0
0
Zürich
Query!
Country [58]
0
0
United Kingdom
Query!
State/province [58]
0
0
Bristol
Query!
Country [59]
0
0
United Kingdom
Query!
State/province [59]
0
0
London
Query!
Country [60]
0
0
United Kingdom
Query!
State/province [60]
0
0
Nottingham
Query!
Country [61]
0
0
United Kingdom
Query!
State/province [61]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI
201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus
(HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated
interferon a-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed
in treatment-naïve (TN) and treatment experienced (TE) patients.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00774397
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
Query!
Address
0
0
Boehringer Ingelheim
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00774397
Download to PDF