Back to results

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

Primary Purpose

Hepatitis C, Chronic

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

BI 201335 NA 240 mg QD / LI

PegIFN/RBV

BI 201335 NA 120mg QD / LI

PegIFN/RBV

BI 201335 NA 240 mg QD

PegIFN/RBV

BI 201335 NA 240 mg QD

PegIFN/RBV

BI 201335 NA 240 mg BID

PegIFN/RBV

BI 201335 NA 240 mg QD

PegIFN/RBV

Placebo

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

240 mg QD TN

240 mg QD / LI-TN

Placebo

120 mg QD / LI-TN

240 mg QD TE

240 mg QD / LI-TE

240 mg BID / LI-TE

Arm Description

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

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 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 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 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

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

Outcomes

Primary Outcome Measures

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'.

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.

Secondary Outcome Measures

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)

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)

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

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

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

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.

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

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

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)

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.

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.

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.

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.

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.

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.

Change From Baseline to Week 24 in Pulse Rate

Baseline is defined as the last value before the administration of BI 201335 or placebo.

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.

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'.

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.

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 .

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.

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 .

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.

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 .

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.

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 .

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.

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.

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.

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.

Full Information

NCT ID

NCT00774397

First Posted

October 16, 2008

Last Updated

October 14, 2015

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00774397

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

719 (Actual)

8. Arms, Groups, and Interventions

Arm Title

240 mg QD TN

Arm Type

Experimental

Arm Description

Arm Title

240 mg QD / LI-TN

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

Arm Title

120 mg QD / LI-TN

Arm Type

Experimental

Arm Description

Arm Title

240 mg QD TE

Arm Type

Experimental

Arm Description

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

Arm Title

240 mg QD / LI-TE

Arm Type

Experimental

Arm Description

Arm Title

240 mg BID / LI-TE

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BI 201335 NA 240 mg QD / LI

Other Intervention Name(s)

Faldaprevir

Intervention Description

240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks

Intervention Type

Drug

Intervention Name(s)

PegIFN/RBV

Intervention Description

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

Intervention Type

Drug

Intervention Name(s)

BI 201335 NA 120mg QD / LI

Other Intervention Name(s)

Faldaprevir

Intervention Description

120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks

Intervention Type

Drug

Intervention Name(s)

PegIFN/RBV

Intervention Description

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

Intervention Type

Drug

Intervention Name(s)

BI 201335 NA 240 mg QD

Other Intervention Name(s)

Faldaprevir

Intervention Description

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

Intervention Type

Drug

Intervention Name(s)

PegIFN/RBV

Intervention Description

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

Intervention Type

Drug

Intervention Name(s)

BI 201335 NA 240 mg QD

Other Intervention Name(s)

Faldaprevir

Intervention Description

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

Intervention Type

Drug

Intervention Name(s)

PegIFN/RBV

Intervention Description

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

Intervention Type

Drug

Intervention Name(s)

BI 201335 NA 240 mg BID

Other Intervention Name(s)

Faldaprevir

Intervention Description

240mg BI 201335 NA (Faldaprevir) twice, 24 weeks

Intervention Type

Drug

Intervention Name(s)

PegIFN/RBV

Intervention Description

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

Intervention Type

Drug

Intervention Name(s)

PegIFN/RBV

Intervention Description

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

Intervention Type

Drug

Intervention Name(s)

BI 201335 NA 240 mg QD

Other Intervention Name(s)

Faldaprevir

Intervention Description

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

Intervention Type

Drug

Intervention Name(s)

PegIFN/RBV

Intervention Description

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 28

Title

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

Description

Time Frame

Day 155 after the end of all treatment

Secondary Outcome Measure Information:

Title

Virological Response at Week 2

Description

Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 2 (< 25 IU/ml, detectable or undetectable)

Time Frame

Week 2

Title

Virological Response at Week 4

Description

Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 4 (< 25 IU/ml, detectable or undetectable)

Time Frame

Week 4

Title

Early Virological Response (EVR)

Description

Early Virological Response (EVR) is defined as ≥ 2 log 10 reduction in plasma HCV RNA level from baseline at Week 12

Time Frame

Baseline and Week 12

Title

Extended Rapid Virological Response (eRVR)

Description

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

Time Frame

Week 4 and Week 12

Title

Complete Early Virological Response (cEVR)

Description

Complete Early Virological Response (cEVR) is defined as plasma HCV RNA level below the lower limit of detection at Week 12

Time Frame

Week 12

Title

End of Treatment Response at Week 24

Description

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.

Time Frame

Week 24

Title

End of Treatment Response at End of All Therapy

Description

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

Time Frame

Week 24 or Week 48

Title

Sustained Virological Response 12 Weeks (SVR12) After Completion of All Therapy

Description

Time Frame

Week 36 or Week 60

Title

Time to Reach a Plasma HCV RNA Level Below the Lower Limit of Detection

Description

Summary of time (i.e Median number of days) to reach a plasma HCV RNA level below limit of detection (BLD)

Time Frame

On or after day 155 post end of all treatment

Title

Time to Loss of Virological Response

Description

Time Frame

Week 24

Title

Virological Rebound

Description

Time Frame

Week 24 or Week 48

Title

Breakthrough on BI 201335/Placebo (Rebound While All 3 Treatments Were Still Ongoing)

Description

Number of patients with Unconfirmed rebound ( ≥ 1log10 increase in HCV mRNA) while on BI201335/placebo + 5 days washout.

Time Frame

Up to Week 24

Title

Breakthrough on PegIFN/RBV (Rebound While Only PegIFN/RBV Treatment Alone Was Still Ongoing)

Description

Number of patients with Unconfirmed rebound (≥ 1log10 increase in HCV mRNA) while on PegIFN/RBV treatment + 5 days washout.

Time Frame

Week 24 through Week 48

Title

Relapse

Description

Time Frame

post-End of treatment (i.e. post 48 weeks)

Title

Change From Baseline to Week 24 in Diastolic Blood Pressure and Systolic Blood Pressure

Description

Baseline is defined as the last value before the initial drug administration of BI 201335 or placebo.

Time Frame

Baseline and Week 24

Title

Change From Baseline to Week 24 in Pulse Rate

Description

Baseline is defined as the last value before the administration of BI 201335 or placebo.

Time Frame

Baseline and Week 24

Title

Change From Baseline to Week 24 in Weight of the Patients

Description

Baseline is defined as the last value before the administration of BI 201335 or placebo.

Time Frame

Baseline and Week 24

Title

Global Assessment of Tolerability

Description

Time Frame

Week 24

Title

Change From Baseline to Week 24 in Haemoglobin of the Patients

Description

Baseline is defined as the last value before the administration of BI 201335 or placebo.

Time Frame

Baseline and Week 24

Title

Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Haemoglobin

Description

Number of patients with normal or high baseline moved to low .

Time Frame

Baseline and Week 24

Title

Change From Baseline to Week 24 in Absolute Neutrophils of the Patients

Description

Baseline is defined as the last value before the administration of BI 201335 or placebo.

Time Frame

Baseline and Week 24

Title

Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Absolute Neutrophils

Description

Number of patients with normal or high baseline moved to low .

Time Frame

Baseline and Week 24

Title

Change From Baseline to Week 24 in ALT/GPT,SGPT of the Patients

Description

Baseline is defined as the last value before the drug administration of BI 201335 or placebo.

Time Frame

Baseline and Week 24

Title

Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter ALT/GPT,SGPT

Description

Number of patients with normal or low baseline moved to high .

Time Frame

Baseline and Week 24

Title

Change From Baseline to Week 24 in Total Bilirubin of the Patients

Description

Baseline is defined as the last value before the administration of BI 201335 or placebo.

Time Frame

Baseline and Week 24

Title

Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Total Bilirubin

Description

Number of patients with normal or low baseline moved to high .

Time Frame

Baseline and Week 24

Title

Trough Concentration (Cpre,ss) of Faldaprevir at Steady State

Description

C(pre,ss) is defined as pre-dose (trough) concentration of Faldaprevir in plasma at steady state immediately before administration of the next dose.

Time Frame

Week 8, week 10, week 12, week 24

Title

Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV)

Description

C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.

Time Frame

Week 8, week 10, week 12, week 24

Title

Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV)

Description

C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.

Time Frame

Week 8, week 10, week 12, week 24

Title

Trough Concentration (Cpre,ss) of PegIFN at Steady State

Description

C(pre,ss) is defined as pre-dose (trough) concentration of PegIFN in plasma at steady state immediately before administration of the next dose.

Time Frame

Week 8, week 10, week 12, week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1220.5.0001 Boehringer Ingelheim Investigational Site

City

San Francisco

State/Province

California

Country

United States

Facility Name

1220.5.0008 Boehringer Ingelheim Investigational Site

City

San Francisco

State/Province

California

Country

United States

Facility Name

1220.5.0005 Boehringer Ingelheim Investigational Site

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

1220.5.0006 Boehringer Ingelheim Investigational Site

City

Lutherville

State/Province

Maryland

Country

United States

Facility Name

1220.5.0002 Boehringer Ingelheim Investigational Site

City

New York

State/Province

New York

Country

United States

Facility Name

1220.5.0003 Boehringer Ingelheim Investigational Site

City

New York

State/Province

New York

Country

United States

Facility Name

1220.5.0007 Boehringer Ingelheim Investigational Site

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

1220.5.0010 Boehringer Ingelheim Investigational Site

City

Germantown

State/Province

Tennessee

Country

United States

Facility Name

1220.5.0009 Boehringer Ingelheim Investigational Site

City

Nashville

State/Province

Tennessee

Country

United States

Facility Name

1220.5.0004 Boehringer Ingelheim Investigational Site

City

Austin

State/Province

Texas

Country

United States

Facility Name

1220.5.5401 Boehringer Ingelheim Investigational Site

City

Capital Federal

Country

Argentina

Facility Name

1220.5.5403 Boehringer Ingelheim Investigational Site

City

Capital Federal

Country

Argentina

Facility Name

1220.5.5405 Boehringer Ingelheim Investigational Site

City

Derqui, Pilar

Country

Argentina

Facility Name

1220.5.5402 Boehringer Ingelheim Investigational Site

City

Rosario

Country

Argentina

Facility Name

1220.5.5406 Boehringer Ingelheim Investigational Site

City

Rosario

Country

Argentina

Facility Name

1220.5.6110 Boehringer Ingelheim Investigational Site

City

Camperdown

State/Province

New South Wales

Country

Australia

Facility Name

1220.5.6109 Boehringer Ingelheim Investigational Site

City

Kogarah

State/Province

New South Wales

Country

Australia

Facility Name

1220.5.6105 Boehringer Ingelheim Investigational Site

City

Randwick

State/Province

New South Wales

Country

Australia

Facility Name

1220.5.6101 Boehringer Ingelheim Investigational Site

City

Westmead

State/Province

New South Wales

Country

Australia

Facility Name

1220.5.6103 Boehringer Ingelheim Investigational Site

City

Herston

State/Province

Queensland

Country

Australia

Facility Name

1220.5.6104 Boehringer Ingelheim Investigational Site

City

Woolloongabba

State/Province

Queensland

Country

Australia

Facility Name

1220.5.6102 Boehringer Ingelheim Investigational Site

City

Clayton

State/Province

Victoria

Country

Australia

Facility Name

1220.5.6107 Boehringer Ingelheim Investigational Site

City

Fitzroy

State/Province

Victoria

Country

Australia

Facility Name

1220.5.6108 Boehringer Ingelheim Investigational Site

City

Parkville

State/Province

Victoria

Country

Australia

Facility Name

1220.5.4303 Boehringer Ingelheim Investigational Site

City

Linz

Country

Austria

Facility Name

1220.5.4301 Boehringer Ingelheim Investigational Site

City

Wien

Country

Austria

Facility Name

1220.5.4302 Boehringer Ingelheim Investigational Site

City

Wien

Country

Austria

Facility Name

1220.5.1003 Boehringer Ingelheim Investigational Site

City

Edmonton

State/Province

Alberta

Country

Canada

Facility Name

1220.5.1007 Boehringer Ingelheim Investigational Site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

1220.5.1006 Boehringer Ingelheim Investigational Site

City

Hamilton

State/Province

Ontario

Country

Canada

Facility Name

1220.5.1001 Boehringer Ingelheim Investigational Site

City

Ottawa

State/Province

Ontario

Country

Canada

Facility Name

1220.5.1002 Boehringer Ingelheim Investigational Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

1220.5.1004 Boehringer Ingelheim Investigational Site

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

1220.5.4202 Boehringer Ingelheim Investigational Site

City

Melnik

Country

Czech Republic

Facility Name

1220.5.4203 Boehringer Ingelheim Investigational Site

City

Opava

Country

Czech Republic

Facility Name

1220.5.3301A Boehringer Ingelheim Investigational Site

City

Clichy

Country

France

Facility Name

1220.5.3307A Boehringer Ingelheim Investigational Site

City

Creteil

Country

France

Facility Name

1220.5.3309A Boehringer Ingelheim Investigational Site

City

Lyon

Country

France

Facility Name

1220.5.3304A Boehringer Ingelheim Investigational Site

City

Marseille

Country

France

Facility Name

1220.5.3306A Boehringer Ingelheim Investigational Site

City

Montpellier

Country

France

Facility Name

1220.5.3308A Boehringer Ingelheim Investigational Site

City

Paris Cedex 20

Country

France

Facility Name

1220.5.3302A Boehringer Ingelheim Investigational Site

City

Paris

Country

France

Facility Name

1220.5.3303A Boehringer Ingelheim Investigational Site

City

Paris

Country

France

Facility Name

1220.5.3305A Boehringer Ingelheim Investigational Site

City

Vandoeuvre Cedex

Country

France

Facility Name

1220.5.4902 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1220.5.4903 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1220.5.4917 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1220.5.4914 Boehringer Ingelheim Investigational Site

City

Bochum

Country

Germany

Facility Name

1220.5.4913 Boehringer Ingelheim Investigational Site

City

Bonn

Country

Germany

Facility Name

1220.5.4915 Boehringer Ingelheim Investigational Site

City

Dortmund

Country

Germany

Facility Name

1220.5.4905 Boehringer Ingelheim Investigational Site

City

Düsseldorf

Country

Germany

Facility Name

1220.5.4912 Boehringer Ingelheim Investigational Site

City

Düsseldorf

Country

Germany

Facility Name

1220.5.4906 Boehringer Ingelheim Investigational Site

City

Frankfurt/Main

Country

Germany

Facility Name

1220.5.4908 Boehringer Ingelheim Investigational Site

City

Hamburg

Country

Germany

Facility Name

1220.5.4904 Boehringer Ingelheim Investigational Site

City

Hannover

Country

Germany

Facility Name

1220.5.4910 Boehringer Ingelheim Investigational Site

City

Leipzig

Country

Germany

Facility Name

1220.5.4909 Boehringer Ingelheim Investigational Site

City

Mainz

Country

Germany

Facility Name

1220.5.4907 Boehringer Ingelheim Investigational Site

City

Tübingen

Country

Germany

Facility Name

1220.5.8210 Boehringer Ingelheim Investigational Site

City

Busan

Country

Korea, Republic of

Facility Name

1220.5.8205 Boehringer Ingelheim Investigational Site

City

Daegu

Country

Korea, Republic of

Facility Name

1220.5.8201 Boehringer Ingelheim Investigational Site

City

Pusan

Country

Korea, Republic of

Facility Name

1220.5.8202 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1220.5.8206 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1220.5.8207 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1220.5.8208 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1220.5.8204 Boehringer Ingelheim Investigational Site

City

Seoungnam

Country

Korea, Republic of

Facility Name

1220.5.8203 Boehringer Ingelheim Investigational Site

City

Sungnam

Country

Korea, Republic of

Facility Name

1220.5.8209 Boehringer Ingelheim Investigational Site

City

Suwon

Country

Korea, Republic of

Facility Name

1220.5.8211 Boehringer Ingelheim Investigational Site

City

Yangsan

Country

Korea, Republic of

Facility Name

1220.5.3101 Boehringer Ingelheim Investigational Site

City

Amsterdam

Country

Netherlands

Facility Name

1220.5.3102 Boehringer Ingelheim Investigational Site

City

Leiden

Country

Netherlands

Facility Name

1220.5.3501 Boehringer Ingelheim Investigational Site

City

Coimbra

Country

Portugal

Facility Name

1220.5.3504 Boehringer Ingelheim Investigational Site

City

Coimbra

Country

Portugal

Facility Name

1220.5.3502 Boehringer Ingelheim Investigational Site

City

Lisboa

Country

Portugal

Facility Name

1220.5.3503 Boehringer Ingelheim Investigational Site

City

Lisboa

Country

Portugal

Facility Name

1220.5.3506 Boehringer Ingelheim Investigational Site

City

Porto

Country

Portugal

Facility Name

1220.5.3507 Boehringer Ingelheim Investigational Site

City

Porto

Country

Portugal

Facility Name

1220.5.4001 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

1220.5.4002 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

1220.5.4003 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

1220.5.4004 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

1220.5.3402 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

1220.5.3405 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

1220.5.3401 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1220.5.3403 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1220.5.3404 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1220.5.3406 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1220.5.4104 Boehringer Ingelheim Investigational Site

City

Bern

Country

Switzerland

Facility Name

1220.5.4102 Boehringer Ingelheim Investigational Site

City

La Chaux-de-Fonds

Country

Switzerland

Facility Name

1220.5.4103 Boehringer Ingelheim Investigational Site

City

Lugano

Country

Switzerland

Facility Name

1220.5.4101 Boehringer Ingelheim Investigational Site

City

Zürich

Country

Switzerland

Facility Name

1220.5.4106 Boehringer Ingelheim Investigational Site

City

Zürich

Country

Switzerland

Facility Name

1220.5.4405 Boehringer Ingelheim Investigational Site

City

Bristol

Country

United Kingdom

Facility Name

1220.5.4401 Boehringer Ingelheim Investigational Site

City

London

Country

United Kingdom

Facility Name

1220.5.4402 Boehringer Ingelheim Investigational Site

City

London

Country

United Kingdom

Facility Name

1220.5.4406 Boehringer Ingelheim Investigational Site

City

London

Country

United Kingdom

Facility Name

1220.5.4409 Boehringer Ingelheim Investigational Site

City

London

Country

United Kingdom

Facility Name

1220.5.4410 Boehringer Ingelheim Investigational Site

City

London

Country

United Kingdom

Facility Name

1220.5.4408 Boehringer Ingelheim Investigational Site

City

Nottingham

Country

United Kingdom

Facility Name

1220.5.4403 Boehringer Ingelheim Investigational Site

City

Southampton

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/

Description

Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Hepatitis C, Chronic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial