This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01528735
First received: February 6, 2012
Last updated: March 14, 2016
Last verified: March 2016
  Purpose
The objective of this trial is to investigate tolerability, safety, pharmacokinetics and antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in Japanese treatment-naive patients with chronic GT-1 HCV infection.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: BI 207127 NA
Drug: peginterferon
Drug: Ribavirin
Drug: BI 201335 NA
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Ascending Dose, Phase II Study to Evaluate Tolerability, Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA in Combination With BI 201335 NA and Ribavirin for 8 Weeks in Treatment-naïve Japanese Patients With Genotype 1chronic Hepatitis C Virus Infection

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of Patients With Drug-related Adverse Events [ Time Frame: From first dose of study medication until 30 days after last dose of study medication, up to 199 days ] [ Designated as safety issue: No ]
    Number of patients with investigator defined drug-related Adverse Events


Secondary Outcome Measures:
  • Percentage of Participants With Virological Response at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Percentage of participants with plasma HCV RNA (hepatitis C virus (HCV) ribonucleic acid (RNA)) level <25 IU/mL (undetected or detected) at week 4.

  • Percentage of Participants With Virological Response at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Percentage of participants with plasma HCV RNA (hepatitis C virus ribonucleic acid ) level <25 IU/mL (undetected or detected) at week 8.

  • Maximum Measured Concentration (Cmax) of Deleobuvir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Maximum measured concentration of BI 207127 (Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).

  • Time From Last Dosing to the Maximum Concentration (Tmax) of Deleobuvir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Time from last dosing to the maximum concentration of Deleobuvir (BI 207127) in plasma after the morning dose of Nth day (Tmax,N).

  • Area Under the Curve (AUC) of Deleobuvir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.

  • Maximum Measured Concentration (Cmax) of Faldaprevir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Maximum measured concentration of Faldaprevir (BI 201335 ZW) in plasma following the morning dose of Nth day (Cmax,N).

  • Time From Last Dosing to the Maximum Concentration (Tmax) of Faldaprevir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Time from last dosing to the maximum concentration of Faldaprevir (BI 201335 ZW) in plasma after the morning dose of Nth day (Tmax,N).

  • Area Under the Curve (AUC) of Faldaprevir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.

  • Maximum Measured Concentration (Cmax) of BI 208333 [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Maximum measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).

  • Time From Last Dosing to the Maximum Concentration (Tmax) of BI 208333 [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Time from last dosing to the maximum concentration of BI 208333 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N).

  • Area Under the Curve (AUC) of BI 208333 [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.

  • Maximum Measured Concentration (Cmax) of CD 6168 [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Maximum measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).

  • Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168 [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Time from last dosing to the maximum concentration of CD 6168 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N).

  • Area Under the Curve (AUC) of CD 6168 [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.

  • Maximum Measured Concentration (Cmax) of CD 6168-AG [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Maximum measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). AG=acylglucuronide.

  • Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168-AG [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Time from last dosing to the maximum concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N). AG=acylglucuronide.

  • Area Under the Curve (AUC) of CD 6168-AG [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. AG=acylglucuronide.

  • Maximum Measured Concentration (Cmax) of RBV [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57 ] [ Designated as safety issue: No ]
    Maximum measured concentration of ribavirin (RBV) in plasma following the morning dose of Nth day (Cmax,N).

  • Time From Last Dosing to the Maximum Concentration (Tmax) of RBV [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57 ] [ Designated as safety issue: No ]
    Time from last dosing to the maximum concentration of ribavirin (RBV) in plasma after the morning dose of Nth day (Tmax,N).

  • Area Under the Curve (AUC) of RBV [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57 ] [ Designated as safety issue: No ]
    Area under the concentration time curve (AUC) of ribavirin (RBV) in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.

  • Cmax Accumulation Ratio (RA,Cmax,N) of Deleobuvir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of Deleobuvir versus itself (RA,Cmax,Met,ss).

  • AUC Accumulation Ratio of Deleobuvir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of Deleobuvir versus itself (RA,AUC,Met,ss).

  • Mean Residence Time (MRTpo,ss) of Deleobuvir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57 ] [ Designated as safety issue: No ]
    Mean residence time of BI 207127 (Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).

  • Apparent Clearance (CL/F,ss) of Deleobuvir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57 ] [ Designated as safety issue: No ]
    Apparent clearance of BI 207127 (Deleobuvir) in plasma following extravascular administration on the 57th day (CL/F,ss).

  • Predose Measured Concentration of Deleobuvir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57 ] [ Designated as safety issue: No ]
    Predose measured concentration of BI 207127 (Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).

  • Cmax Accumulation Ratio (RA,Cmax,N) of Faldaprevir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N).

  • AUC Accumulation Ratio of Faldaprevir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N).

  • Mean Residence Time (MRTpo,ss) of Faldaprevir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57 ] [ Designated as safety issue: No ]

    Mean residence time of Faldaprevir (BI 201335 ZW) in the body after oral administration at steady state (MRTpo,ss).

    This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.


  • Apparent Clearance (CL/F,ss) of Faldaprevir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57 ] [ Designated as safety issue: No ]
    Apparent clearance of Faldaprevir (BI 201335 ZW) in plasma following extravascular administration on the 57th day (CL/F,ss).

  • Predose Measured Concentration of Faldaprevir [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57 ] [ Designated as safety issue: No ]
    Predose measured concentration of Faldaprevir (BI 201335 ZW) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).

  • Cmax Accumulation Ratio of BI 208333 [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of BI 208333 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss).

  • AUC Accumulation Ratio of BI 208333 [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of BI 208333 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss).

  • Mean Residence Time (MRTpo,ss) of BI 208333 [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57 ] [ Designated as safety issue: No ]

    Mean residence time of BI 208333 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).

    This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.


  • Predose Measured Concentration of BI 208333 [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57 ] [ Designated as safety issue: No ]
    Predose measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).

  • Cmax Accumulation Ratio of CD 6168 [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss).

  • AUC Accumulation Ratio of CD 6168 [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss).

  • Mean Residence Time (MRTpo,ss) of CD 6168 [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57 ] [ Designated as safety issue: No ]

    Mean residence time of CD 6168 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).

    This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.


  • Predose Measured Concentration of CD 6168 [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57 ] [ Designated as safety issue: No ]
    Predose measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).

  • Cmax Accumulation Ratio of CD 6168-AG [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168-AG versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss). AG=acylglucuronide.

  • AUC Accumulation Ratio of CD 6168-AG [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57 ] [ Designated as safety issue: No ]
    Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168-AG versus AUC,ss of Deleobuvir (RA,AUC,Met,ss). AG=acylglucuronide.

  • Mean Residence Time (MRTpo,ss) of CD 6168-AG [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57 ] [ Designated as safety issue: No ]

    Mean residence time of CD 6168-AG (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss). AG=acylglucuronide.

    This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.


  • Predose Measured Concentration of CD 6168-AG [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57 ] [ Designated as safety issue: No ]
    Predose measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). AG=acylglucuronide.

  • AUC Accumulation Ratio of RBV [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57 ] [ Designated as safety issue: No ]
    Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the 57th day and after the first dose (RA,AUC,57).

  • Cmax Accumulation Ratio (RA,Cmax,57) of RBV [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57 ] [ Designated as safety issue: No ]
    Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the 57th day and after the first dose (RA,Cmax,57).

  • Mean Residence Time (MRTpo,ss) of RBV [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on day 57 ] [ Designated as safety issue: No ]

    Mean residence time of ribavirin (RBV) in the body after oral administration at steady state (MRTpo,ss).

    This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.


  • Predose Measured Concentration of RBV [ Time Frame: 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 11 and 57 ] [ Designated as safety issue: No ]
    Predose measured concentration of ribavirin (RBV) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).


Enrollment: 25
Study Start Date: February 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 207127 NA, BI 201335 NA(high dose), R
Patients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks
Drug: peginterferon
per package insert
Drug: Ribavirin
per weight BID
Drug: BI 207127 NA
one fix dose
Drug: BI 201335 NA
high dose
Experimental: BI 207127 NA,BI 201335 NA(low dose),RBV
Patients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks
Drug: BI 207127 NA
one fix dose
Drug: Ribavirin
per weight BID
Drug: BI 201335 NA
low dose
Drug: peginterferon
per package insert

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Chronic hepatitis C, diagnosed by positive anti-hepatitis C virus(HCV) antibodies and detected HCV ribonucleic acid(RNA) at screening in addition to:

    1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
    2. liver biopsy consistent with chronic HCV infection.
  • HCV infection of genotype 1 confirmed by genotypic testing at screening
  • Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
  • Plasma HCV RNA = 100,000 IU/mL at screening

Exclusion criteria:

  • Hepatitis C infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
  • Human immunodeficiency virus (HIV) co-infection
  • Decompensated liver disease, or history of decompensated liver disease
  • Body weight < 40 or > 125 kg at screening
  • Hemoglobin <12.0g/dL for women and <13.0g/dL for men at screening
  • White blood cell count <3000 cells/mm3 at screening
  • Absolute neutrophil count < 1,500 cells/mm3 at screening
  • Platelet count < 90,000 /mm3 at screening
  • Serum creatinine > 1.5xUpper Limit of Normal range(ULN) or creatinine clearance =50 mL/min at screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528735

Locations
Japan
1241.25.002 Boehringer Ingelheim Investigational Site
Kofu, Yamanashi, Japan
1241.25.005 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama, Japan
1241.25.003 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1241.25.004 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo, Japan
1241.25.001 Boehringer Ingelheim Investigational Site
Omura, Nagasaki, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01528735     History of Changes
Other Study ID Numbers: 1241.25 
Study First Received: February 6, 2012
Results First Received: January 21, 2016
Last Updated: March 14, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 25, 2016