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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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)
Secondary ID [1] 0 0
2008-003538-11
Secondary ID [2] 0 0
1220.5
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo
Timepoint [1] 0 0
Week 28
Primary outcome [2] 0 0
Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy
Timepoint [2] 0 0
Day 155 after the end of all treatment
Secondary outcome [1] 0 0
Virological Response at Week 2
Timepoint [1] 0 0
Week 2
Secondary outcome [2] 0 0
Virological Response at Week 4
Timepoint [2] 0 0
Week 4
Secondary outcome [3] 0 0
Early Virological Response (EVR)
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [4] 0 0
Extended Rapid Virological Response (eRVR)
Timepoint [4] 0 0
Week 4 and Week 12
Secondary outcome [5] 0 0
Complete Early Virological Response (cEVR)
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
End of Treatment Response at Week 24
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
End of Treatment Response at End of All Therapy
Timepoint [7] 0 0
Week 24 or Week 48
Secondary outcome [8] 0 0
Sustained Virological Response 12 Weeks (SVR12) After Completion of All Therapy
Timepoint [8] 0 0
Week 36 or Week 60
Secondary outcome [9] 0 0
Time to Reach a Plasma HCV RNA Level Below the Lower Limit of Detection
Timepoint [9] 0 0
On or after day 155 post end of all treatment
Secondary outcome [10] 0 0
Time to Loss of Virological Response
Timepoint [10] 0 0
Week 24
Secondary outcome [11] 0 0
Virological Rebound
Timepoint [11] 0 0
Week 24 or Week 48
Secondary outcome [12] 0 0
Breakthrough on BI 201335/Placebo (Rebound While All 3 Treatments Were Still Ongoing)
Timepoint [12] 0 0
Up to Week 24
Secondary outcome [13] 0 0
Breakthrough on PegIFN/RBV (Rebound While Only PegIFN/RBV Treatment Alone Was Still Ongoing)
Timepoint [13] 0 0
Week 24 through Week 48
Secondary outcome [14] 0 0
Relapse
Timepoint [14] 0 0
post-End of treatment (i.e. post 48 weeks)
Secondary outcome [15] 0 0
Change From Baseline to Week 24 in Diastolic Blood Pressure and Systolic Blood Pressure
Timepoint [15] 0 0
Baseline and Week 24
Secondary outcome [16] 0 0
Change From Baseline to Week 24 in Pulse Rate
Timepoint [16] 0 0
Baseline and Week 24
Secondary outcome [17] 0 0
Change From Baseline to Week 24 in Weight of the Patients
Timepoint [17] 0 0
Baseline and Week 24
Secondary outcome [18] 0 0
Global Assessment of Tolerability
Timepoint [18] 0 0
Week 24
Secondary outcome [19] 0 0
Change From Baseline to Week 24 in Haemoglobin of the Patients
Timepoint [19] 0 0
Baseline and Week 24
Secondary outcome [20] 0 0
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Haemoglobin
Timepoint [20] 0 0
Baseline and Week 24
Secondary outcome [21] 0 0
Change From Baseline to Week 24 in Absolute Neutrophils of the Patients
Timepoint [21] 0 0
Baseline and Week 24
Secondary outcome [22] 0 0
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Absolute Neutrophils
Timepoint [22] 0 0
Baseline and Week 24
Secondary outcome [23] 0 0
Change From Baseline to Week 24 in ALT/GPT,SGPT of the Patients
Timepoint [23] 0 0
Baseline and Week 24
Secondary outcome [24] 0 0
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter ALT/GPT,SGPT
Timepoint [24] 0 0
Baseline and Week 24
Secondary outcome [25] 0 0
Change From Baseline to Week 24 in Total Bilirubin of the Patients
Timepoint [25] 0 0
Baseline and Week 24
Secondary outcome [26] 0 0
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Total Bilirubin
Timepoint [26] 0 0
Baseline and Week 24
Secondary outcome [27] 0 0
Trough Concentration (Cpre,ss) of Faldaprevir at Steady State
Timepoint [27] 0 0
Week 8, week 10, week 12, week 24
Secondary outcome [28] 0 0
Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV)
Timepoint [28] 0 0
Week 8, week 10, week 12, week 24
Secondary outcome [29] 0 0
Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV)
Timepoint [29] 0 0
Week 8, week 10, week 12, week 24
Secondary outcome [30] 0 0
Trough Concentration (Cpre,ss) of PegIFN at Steady State
Timepoint [30] 0 0
Week 8, week 10, week 12, week 24

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
719
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
1220.5.6110 Boehringer Ingelheim Investigational Site - Camperdown
Recruitment hospital [2] 0 0
1220.5.6109 Boehringer Ingelheim Investigational Site - Kogarah
Recruitment hospital [3] 0 0
1220.5.6105 Boehringer Ingelheim Investigational Site - Randwick
Recruitment hospital [4] 0 0
1220.5.6101 Boehringer Ingelheim Investigational Site - Westmead
Recruitment hospital [5] 0 0
1220.5.6103 Boehringer Ingelheim Investigational Site - Herston
Recruitment hospital [6] 0 0
1220.5.6104 Boehringer Ingelheim Investigational Site - Woolloongabba
Recruitment hospital [7] 0 0
1220.5.6102 Boehringer Ingelheim Investigational Site - Clayton
Recruitment hospital [8] 0 0
1220.5.6107 Boehringer Ingelheim Investigational Site - Fitzroy
Recruitment hospital [9] 0 0
1220.5.6108 Boehringer Ingelheim Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Randwick
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment postcode(s) [5] 0 0
- Herston
Recruitment postcode(s) [6] 0 0
- Woolloongabba
Recruitment postcode(s) [7] 0 0
- Clayton
Recruitment postcode(s) [8] 0 0
- Fitzroy
Recruitment postcode(s) [9] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Argentina
State/province [8] 0 0
Capital Federal
Country [9] 0 0
Argentina
State/province [9] 0 0
Derqui, Pilar
Country [10] 0 0
Argentina
State/province [10] 0 0
Rosario
Country [11] 0 0
Austria
State/province [11] 0 0
Linz
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Melnik
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Opava
Country [19] 0 0
France
State/province [19] 0 0
Clichy
Country [20] 0 0
France
State/province [20] 0 0
Creteil
Country [21] 0 0
France
State/province [21] 0 0
Lyon
Country [22] 0 0
France
State/province [22] 0 0
Marseille
Country [23] 0 0
France
State/province [23] 0 0
Montpellier
Country [24] 0 0
France
State/province [24] 0 0
Paris Cedex 20
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
France
State/province [26] 0 0
Vandoeuvre Cedex
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Bochum
Country [29] 0 0
Germany
State/province [29] 0 0
Bonn
Country [30] 0 0
Germany
State/province [30] 0 0
Dortmund
Country [31] 0 0
Germany
State/province [31] 0 0
Düsseldorf
Country [32] 0 0
Germany
State/province [32] 0 0
Frankfurt/Main
Country [33] 0 0
Germany
State/province [33] 0 0
Hamburg
Country [34] 0 0
Germany
State/province [34] 0 0
Hannover
Country [35] 0 0
Germany
State/province [35] 0 0
Leipzig
Country [36] 0 0
Germany
State/province [36] 0 0
Mainz
Country [37] 0 0
Germany
State/province [37] 0 0
Tübingen
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Busan
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Daegu
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Pusan
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seoungnam
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Sungnam
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Suwon
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Yangsan
Country [46] 0 0
Netherlands
State/province [46] 0 0
Amsterdam
Country [47] 0 0
Netherlands
State/province [47] 0 0
Leiden
Country [48] 0 0
Portugal
State/province [48] 0 0
Coimbra
Country [49] 0 0
Portugal
State/province [49] 0 0
Lisboa
Country [50] 0 0
Portugal
State/province [50] 0 0
Porto
Country [51] 0 0
Romania
State/province [51] 0 0
Bucharest
Country [52] 0 0
Spain
State/province [52] 0 0
Barcelona
Country [53] 0 0
Spain
State/province [53] 0 0
Madrid
Country [54] 0 0
Switzerland
State/province [54] 0 0
Bern
Country [55] 0 0
Switzerland
State/province [55] 0 0
La Chaux-de-Fonds
Country [56] 0 0
Switzerland
State/province [56] 0 0
Lugano
Country [57] 0 0
Switzerland
State/province [57] 0 0
Zürich
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Bristol
Country [59] 0 0
United Kingdom
State/province [59] 0 0
London
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Nottingham
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00774397
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00774397