Hepatitis C, ChronicPhase 2NCT00774397

Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)

A Phase 2 study testing BI 201335 NA 240 mg QD / LI, PegIFN/RBV and BI 201335 NA 120mg QD / LI in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 100 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: BI 201335 NA 240 mg QD / LI, PegIFN/RBV and BI 201335 NA 120mg QD / LI
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 719 participants
Where: 100 sitesin 15 countries
Study dates: Oct 2008to Nov 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

100 sites in 15 countries.

Country

City, postcode or hospital

100 sites in 15 countries

Germany14 sites

1220.5.4902 Boehringer Ingelheim Investigational Site
Berlin
1220.5.4903 Boehringer Ingelheim Investigational Site
Berlin
1220.5.4917 Boehringer Ingelheim Investigational Site
Berlin
1220.5.4914 Boehringer Ingelheim Investigational Site
Bochum
1220.5.4913 Boehringer Ingelheim Investigational Site
Bonn
1220.5.4915 Boehringer Ingelheim Investigational Site
Dortmund
1220.5.4905 Boehringer Ingelheim Investigational Site
Düsseldorf
1220.5.4912 Boehringer Ingelheim Investigational Site
Düsseldorf
1220.5.4906 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1220.5.4908 Boehringer Ingelheim Investigational Site
Hamburg
1220.5.4904 Boehringer Ingelheim Investigational Site
Hanover
1220.5.4910 Boehringer Ingelheim Investigational Site
Leipzig
1220.5.4909 Boehringer Ingelheim Investigational Site
Mainz
1220.5.4907 Boehringer Ingelheim Investigational Site
Tübingen

Other trials in Germany

South Korea11 sites

1220.5.8210 Boehringer Ingelheim Investigational Site
Busan
1220.5.8205 Boehringer Ingelheim Investigational Site
Daegu
1220.5.8201 Boehringer Ingelheim Investigational Site
Pusan
1220.5.8202 Boehringer Ingelheim Investigational Site
Seoul
1220.5.8206 Boehringer Ingelheim Investigational Site
Seoul
1220.5.8207 Boehringer Ingelheim Investigational Site
Seoul
1220.5.8208 Boehringer Ingelheim Investigational Site
Seoul
1220.5.8204 Boehringer Ingelheim Investigational Site
Seoungnam
1220.5.8203 Boehringer Ingelheim Investigational Site
Sungnam
1220.5.8209 Boehringer Ingelheim Investigational Site
Suwon
1220.5.8211 Boehringer Ingelheim Investigational Site
Yangsan

Other trials in South Korea

United States10 sites

1220.5.0004 Boehringer Ingelheim Investigational Site
Austin, Texas
1220.5.0005 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1220.5.0010 Boehringer Ingelheim Investigational Site
Germantown, Tennessee
1220.5.0006 Boehringer Ingelheim Investigational Site
Lutherville, Maryland
1220.5.0009 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
1220.5.0002 Boehringer Ingelheim Investigational Site
New York, New York
1220.5.0003 Boehringer Ingelheim Investigational Site
New York, New York
1220.5.0007 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1220.5.0001 Boehringer Ingelheim Investigational Site
San Francisco, California
1220.5.0008 Boehringer Ingelheim Investigational Site
San Francisco, California

Other trials in United States

Australia9 sites

1220.5.6110 Boehringer Ingelheim Investigational Site
Camperdown, New South Wales
1220.5.6102 Boehringer Ingelheim Investigational Site
Clayton, Victoria
1220.5.6107 Boehringer Ingelheim Investigational Site
Fitzroy, Victoria
1220.5.6103 Boehringer Ingelheim Investigational Site
Herston, Queensland
1220.5.6109 Boehringer Ingelheim Investigational Site
Kogarah, New South Wales
1220.5.6108 Boehringer Ingelheim Investigational Site
Parkville, Victoria
1220.5.6105 Boehringer Ingelheim Investigational Site
Randwick, New South Wales
1220.5.6101 Boehringer Ingelheim Investigational Site
Westmead, New South Wales
1220.5.6104 Boehringer Ingelheim Investigational Site
Woolloongabba, Queensland

Other trials in Australia

France9 sites

1220.5.3301A Boehringer Ingelheim Investigational Site
Clichy
1220.5.3307A Boehringer Ingelheim Investigational Site
Créteil
1220.5.3309A Boehringer Ingelheim Investigational Site
Lyon
1220.5.3304A Boehringer Ingelheim Investigational Site
Marseille
1220.5.3306A Boehringer Ingelheim Investigational Site
Montpellier
1220.5.3302A Boehringer Ingelheim Investigational Site
Paris
1220.5.3303A Boehringer Ingelheim Investigational Site
Paris
1220.5.3308A Boehringer Ingelheim Investigational Site
Paris
1220.5.3305A Boehringer Ingelheim Investigational Site
Vandœuvre-lès-Nancy

Other trials in France

United Kingdom8 sites

1220.5.4405 Boehringer Ingelheim Investigational Site
Bristol
1220.5.4401 Boehringer Ingelheim Investigational Site
London
1220.5.4402 Boehringer Ingelheim Investigational Site
London
1220.5.4406 Boehringer Ingelheim Investigational Site
London
1220.5.4409 Boehringer Ingelheim Investigational Site
London
1220.5.4410 Boehringer Ingelheim Investigational Site
London
1220.5.4408 Boehringer Ingelheim Investigational Site
Nottingham
1220.5.4403 Boehringer Ingelheim Investigational Site
Southampton

Other trials in United Kingdom

Canada6 sites

1220.5.1003 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1220.5.1006 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1220.5.1004 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1220.5.1001 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
1220.5.1002 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1220.5.1007 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

Other trials in Canada

Portugal6 sites

1220.5.3501 Boehringer Ingelheim Investigational Site
Coimbra
1220.5.3504 Boehringer Ingelheim Investigational Site
Coimbra
1220.5.3502 Boehringer Ingelheim Investigational Site
Lisbon
1220.5.3503 Boehringer Ingelheim Investigational Site
Lisbon
1220.5.3506 Boehringer Ingelheim Investigational Site
Porto
1220.5.3507 Boehringer Ingelheim Investigational Site
Porto

Other trials in Portugal

Spain6 sites

1220.5.3402 Boehringer Ingelheim Investigational Site
Barcelona
1220.5.3405 Boehringer Ingelheim Investigational Site
Barcelona
1220.5.3401 Boehringer Ingelheim Investigational Site
Madrid
1220.5.3403 Boehringer Ingelheim Investigational Site
Madrid
1220.5.3404 Boehringer Ingelheim Investigational Site
Madrid
1220.5.3406 Boehringer Ingelheim Investigational Site
Madrid

Other trials in Spain

Argentina5 sites

1220.5.5401 Boehringer Ingelheim Investigational Site
Capital Federal
1220.5.5403 Boehringer Ingelheim Investigational Site
Capital Federal
1220.5.5405 Boehringer Ingelheim Investigational Site
Derqui, Pilar
1220.5.5402 Boehringer Ingelheim Investigational Site
Rosario
1220.5.5406 Boehringer Ingelheim Investigational Site
Rosario

Other trials in Argentina

Switzerland5 sites

1220.5.4104 Boehringer Ingelheim Investigational Site
Bern
1220.5.4102 Boehringer Ingelheim Investigational Site
La Chaux-de-Fonds
1220.5.4103 Boehringer Ingelheim Investigational Site
Lugano
1220.5.4101 Boehringer Ingelheim Investigational Site
Zurich
1220.5.4106 Boehringer Ingelheim Investigational Site
Zurich

Other trials in Switzerland

Romania4 sites

1220.5.4001 Boehringer Ingelheim Investigational Site
Bucharest
1220.5.4002 Boehringer Ingelheim Investigational Site
Bucharest
1220.5.4003 Boehringer Ingelheim Investigational Site
Bucharest
1220.5.4004 Boehringer Ingelheim Investigational Site
Bucharest

Other trials in Romania

Austria3 sites

1220.5.4303 Boehringer Ingelheim Investigational Site
Linz
1220.5.4301 Boehringer Ingelheim Investigational Site
Vienna
1220.5.4302 Boehringer Ingelheim Investigational Site
Vienna

Other trials in Austria

Czechia2 sites

1220.5.4202 Boehringer Ingelheim Investigational Site
Mělník
1220.5.4203 Boehringer Ingelheim Investigational Site
Opava

Other trials in Czechia

Netherlands2 sites

1220.5.3101 Boehringer Ingelheim Investigational Site
Amsterdam
1220.5.3102 Boehringer Ingelheim Investigational Site
Leiden

Other trials in Netherlands

About this study

Official 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)

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 α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.

Conditions: Hepatitis C, Chronic
Being tested: BI 201335 NA 240 mg QD / LI, PegIFN/RBV, BI 201335 NA 120mg QD / LI, BI 201335 NA 240 mg QD, BI 201335 NA 240 mg BID
Medical subject headings: Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 201335 NA 240 mg QD / LIDrug
Also called Faldaprevir
240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks
PegIFN/RBVDrug
PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks
BI 201335 NA 120mg QD / LIDrug
Also called Faldaprevir
120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks
PegIFN/RBVDrug
PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
BI 201335 NA 240 mg QDDrug
Also called Faldaprevir
240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks
PegIFN/RBVDrug
PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
BI 201335 NA 240 mg QDDrug
Also called Faldaprevir
240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks
PegIFN/RBVDrug
PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks
BI 201335 NA 240 mg BIDDrug
Also called Faldaprevir
240mg BI 201335 NA (Faldaprevir) twice, 24 weeks
PegIFN/RBVDrug
PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
PegIFN/RBVDrug
PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks
BI 201335 NA 240 mg QDDrug
Also called Faldaprevir
240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks
PegIFN/RBVDrug
PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks
PlaceboDrug
Placebo

Study groups in NCT00774397
Study group	Role	What they receive
240 mg QD TN	Experimental	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 Receives: Drug: BI 201335 NA 240 mg QD; Drug: PegIFN/RBV
240 mg QD / LI-TN	Experimental	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 Receives: Drug: BI 201335 NA 240 mg QD / LI; Drug: PegIFN/RBV
Placebo	Placebo comparator	Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients Receives: Drug: PegIFN/RBV; Drug: Placebo
120 mg QD / LI-TN	Experimental	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 Receives: Drug: BI 201335 NA 120mg QD / LI; Drug: PegIFN/RBV
240 mg QD TE	Experimental	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 Receives: Drug: BI 201335 NA 240 mg QD; Drug: PegIFN/RBV
240 mg QD / LI-TE	Experimental	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 Receives: Drug: PegIFN/RBV; Drug: BI 201335 NA 240 mg QD
240 mg BID / LI-TE	Experimental	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 Receives: Drug: BI 201335 NA 240 mg BID; Drug: PegIFN/RBV

What is being measured

The primary outcome is the main question the study is designed to answer.

Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo
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'.
Measured: Week 28
Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy
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.
Measured: Day 155 after the end of all treatment

Secondary outcomes (30)

Virological Response at Week 2
Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 2 (< 25 IU/ml, detectable or undetectable)
Measured: Week 2
Virological Response at Week 4
Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 4 (< 25 IU/ml, detectable or undetectable)
Measured: Week 4
Early Virological Response (EVR)
Early Virological Response (EVR) is defined as ≥ 2 log 10 reduction in plasma HCV RNA level from baseline at Week 12
Measured: Baseline and Week 12
Extended Rapid Virological Response (eRVR)
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
Measured: Week 4 and Week 12
Complete Early Virological Response (cEVR)
Complete Early Virological Response (cEVR) is defined as plasma HCV RNA level below the lower limit of detection at Week 12
Measured: Week 12
End of Treatment Response at Week 24
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.
Measured: Week 24
End of Treatment Response at End of All Therapy
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
Measured: Week 24 or Week 48
Sustained Virological Response 12 Weeks (SVR12) After Completion of All Therapy
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
Measured: Week 36 or Week 60
Time to Reach a Plasma HCV RNA Level Below the Lower Limit of Detection
Summary of time (i.e Median number of days) to reach a plasma HCV RNA level below limit of detection (BLD)
Measured: On or after day 155 post end of all treatment
Time to Loss of Virological Response
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.
Measured: Week 24
Virological Rebound
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.
Measured: Week 24 or Week 48
Breakthrough on BI 201335/Placebo (Rebound While All 3 Treatments Were Still Ongoing)
Number of patients with Unconfirmed rebound ( ≥ 1log10 increase in HCV mRNA) while on BI201335/placebo + 5 days washout.
Measured: Up to Week 24
Breakthrough on PegIFN/RBV (Rebound While Only PegIFN/RBV Treatment Alone Was Still Ongoing)
Number of patients with Unconfirmed rebound (≥ 1log10 increase in HCV mRNA) while on PegIFN/RBV treatment + 5 days washout.
Measured: Week 24 through Week 48
Relapse
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.
Measured: post-End of treatment (i.e. post 48 weeks)
Change From Baseline to Week 24 in Diastolic Blood Pressure and Systolic Blood Pressure
Baseline is defined as the last value before the initial drug administration of BI 201335 or placebo.
Measured: Baseline and Week 24
Change From Baseline to Week 24 in Pulse Rate
Baseline is defined as the last value before the administration of BI 201335 or placebo.
Measured: Baseline and Week 24
Change From Baseline to Week 24 in Weight of the Patients
Baseline is defined as the last value before the administration of BI 201335 or placebo.
Measured: Baseline and Week 24
Global Assessment of Tolerability
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'.
Measured: Week 24
Change From Baseline to Week 24 in Haemoglobin of the Patients
Baseline is defined as the last value before the administration of BI 201335 or placebo.
Measured: Baseline and Week 24
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Haemoglobin
Number of patients with normal or high baseline moved to low .
Measured: Baseline and Week 24
Change From Baseline to Week 24 in Absolute Neutrophils of the Patients
Baseline is defined as the last value before the administration of BI 201335 or placebo.
Measured: Baseline and Week 24
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Absolute Neutrophils
Number of patients with normal or high baseline moved to low .
Measured: Baseline and Week 24
Change From Baseline to Week 24 in ALT/GPT,SGPT of the Patients
Baseline is defined as the last value before the drug administration of BI 201335 or placebo.
Measured: Baseline and Week 24
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter ALT/GPT,SGPT
Number of patients with normal or low baseline moved to high .
Measured: Baseline and Week 24
Change From Baseline to Week 24 in Total Bilirubin of the Patients
Baseline is defined as the last value before the administration of BI 201335 or placebo.
Measured: Baseline and Week 24
Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Total Bilirubin
Number of patients with normal or low baseline moved to high .
Measured: Baseline and Week 24
Trough Concentration (Cpre,ss) of Faldaprevir at Steady State
C(pre,ss) is defined as pre-dose (trough) concentration of Faldaprevir in plasma at steady state immediately before administration of the next dose.
Measured: Week 8, week 10, week 12, week 24
Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV)
C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.
Measured: Week 8, week 10, week 12, week 24
Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV)
C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.
Measured: Week 8, week 10, week 12, week 24
Trough Concentration (Cpre,ss) of PegIFN at Steady State
C(pre,ss) is defined as pre-dose (trough) concentration of PegIFN in plasma at steady state immediately before administration of the next dose.
Measured: Week 8, week 10, week 12, week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Nov 2011

First posted17 Oct 2008 (estimated)
Study startOct 2008
Primary completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 719 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00774397
Sponsor's protocol ID: 1220.5
Other IDs: 2008-003538-11, 2008
Status last verified: Oct 2015
First submitted: 16 Oct 2008
Last updated: 16 Nov 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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)
ClinicalTrials.gov ID: NCT00774397
Acronym / sponsor ID: 1220.5
Conditions: Hepatitis C, Chronic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 719 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Nov 2011 (actual)
First posted: 17 Oct 2008 (estimated)
Results: Posted 16 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 7

Arm	Type	Receives
240 mg QD TN	Experimental	Drug: BI 201335 NA 240 mg QD, Drug: PegIFN/RBV240 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
240 mg QD / LI-TN	Experimental	Drug: BI 201335 NA 240 mg QD / LI, Drug: PegIFN/RBV240 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	Placebo comparator	Drug: PegIFN/RBV, Drug: PlaceboPlacebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
120 mg QD / LI-TN	Experimental	Drug: BI 201335 NA 120mg QD / LI, Drug: PegIFN/RBV120 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
240 mg QD TE	Experimental	Drug: BI 201335 NA 240 mg QD, Drug: PegIFN/RBV240 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
240 mg QD / LI-TE	Experimental	Drug: PegIFN/RBV, Drug: BI 201335 NA 240 mg QD240 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
240 mg BID / LI-TE	Experimental	Drug: BI 201335 NA 240 mg BID, Drug: PegIFN/RBV240mg 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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 201335 NA 240 mg QD / LIAlso: Faldaprevir240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks	Drug	240 mg QD / LI-TN
PegIFN/RBVPegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks	Drug	240 mg QD / LI-TN
BI 201335 NA 120mg QD / LIAlso: Faldaprevir120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks	Drug	120 mg QD / LI-TN
PegIFN/RBVPegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks	Drug	120 mg QD / LI-TN
BI 201335 NA 240 mg QDAlso: Faldaprevir240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks	Drug	240 mg QD TN
PegIFN/RBVPegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks	Drug	240 mg QD TN
BI 201335 NA 240 mg QDAlso: Faldaprevir240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks	Drug	240 mg QD TE
PegIFN/RBVPegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks	Drug	240 mg QD TE
BI 201335 NA 240 mg BIDAlso: Faldaprevir240mg BI 201335 NA (Faldaprevir) twice, 24 weeks	Drug	240 mg BID / LI-TE
PegIFN/RBVPegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks	Drug	240 mg BID / LI-TE
PegIFN/RBVPegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks	Drug	240 mg QD / LI-TE
BI 201335 NA 240 mg QDAlso: Faldaprevir240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks	Drug	240 mg QD / LI-TE
PegIFN/RBVPegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks	Drug	Placebo
PlaceboPlacebo	Drug	Placebo

Primary outcome

Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo
Time frame: Week 28
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'.
Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy
Time frame: Day 155 after the end of all treatment
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.

30 secondary outcomes

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

Results and safety

Results posted to the registry on 16 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo-TN	71	57
120 mg QD / LI-TN	69	56
240 mg QD / LI-TN	143	113
240 mg QD-TN	146	129
240 mg QD / LI-TE	143	97
240 mg QD-TE	76	54
240 mg BID / LI-TE	71	41

Primary outcome: Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo

Time frame: Week 28. Number. Unit: percentage of patients

Measure	Placebo-TN n = 13	120 mg QD / LI-TN n = 14	240 mg QD / LI-TN n = 77	240 mg QD-TN n = 72	240 mg QD / LI-TE n = 88	240 mg QD-TE n = 30	240 mg BID / LI-TE n = 27
Value	0.0	14.3	59.7	75.0	20.5	3.3	0.0

Population analysed: Per protocol set (PPS): PPS was subset of full analysis set,consisted of all patients without important protocol deviations . FAS was composed of all randomised patients who took at least 1 dose of study medication. For this outcome, only patients who were not on PegIFN/RBV treatment 4 weeks after stop of BI 201335 or Placebo were investigated.

Primary outcome: Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy

Time frame: Day 155 after the end of all treatment. Number (95% Confidence Interval). Unit: percentage of patients

Measure	Placebo-TN n = 71	120 mg QD / LI-TN n = 69	240 mg QD / LI-TN n = 141	240 mg QD-TN n = 142	240 mg QD / LI-TE n = 142	240 mg QD-TE n = 76	240 mg BID / LI-TE n = 70
Value	56.3 (44.7 to 67.3)	72.5 (60.9 to 81.6)	72.3 (64.4 to 79.1)	83.8 (76.9 to 88.9)	28.2 (21.4 to 36.1)	40.8 (30.4 to 52.1)	31.4 (21.8 to 43.1)

Placebo-TN vs 120 mg QD / LI-TN: p = 0.0537, Fisher Exact
Placebo-TN vs 240 mg QD / LI-TN: p = 0.0213, Fisher Exact
Placebo-TN vs 240 mg QD-TN: p <0.0001, Fisher Exact

Population analysed: Per protocol set

30 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo-TN	2 of 71 (2.8%)	65 of 71 (91.5%)	Not reported
120mg QD/LI-TN	3 of 68 (4.4%)	65 of 68 (95.6%)	Not reported
240mg QD/LI-TN	18 of 138 (13%)	135 of 138 (97.8%)	Not reported
240mg QD-TN	12 of 149 (8.1%)	143 of 149 (96%)	Not reported
240mg QD/LI-TE	10 of 141 (7.1%)	135 of 141 (95.7%)	Not reported
240mg QD-TE	5 of 76 (6.6%)	74 of 76 (97.4%)	Not reported
240mg BID/LI-TE	13 of 69 (18.8%)	68 of 69 (98.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

100 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 201335 NA 240 mg QD / LI, PegIFN/RBV and BI 201335 NA 120mg QD / LI in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 100 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in Germany, South Korea, United States, Australia, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo (time frame: Week 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00774397.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015.