Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01579474
First received: April 12, 2012
Last updated: July 3, 2015
Last verified: July 2015

April 12, 2012
July 3, 2015
April 2012
December 2013   (final data collection date for primary outcome measure)
Number of Patients With Investigator Defined Drug-related Adverse Events [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Not Provided
Complete list of historical versions of study NCT01579474 on ClinicalTrials.gov Archive Site
  • Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT) [ Time Frame: EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60) ] [ Designated as safety issue: No ]
    Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration
  • Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT) [ Time Frame: EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72) ] [ Designated as safety issue: No ]
    Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration
  • Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8 [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8
  • Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES [ Time Frame: EOT (up to Week 24 or 48) ] [ Designated as safety issue: No ]
    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
  • Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO [ Time Frame: EOT (up to Week 24 or 48) ] [ Designated as safety issue: No ]
    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
  • Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES [ Time Frame: 12 weeks after the EOT (up to Week 36 or 60) ] [ Designated as safety issue: No ]
    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
  • Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO [ Time Frame: 12 weeks after the EOT (up to Week 36 or 60) ] [ Designated as safety issue: No ]
    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
  • Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES [ Time Frame: EOT (up to Week 24 or 48) ] [ Designated as safety issue: No ]
    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
  • Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO [ Time Frame: EOT (up to Week 24 or 48) ] [ Designated as safety issue: No ]
    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
  • Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES [ Time Frame: 12 weeks after the EOT (up to Week 36 or 60) ] [ Designated as safety issue: No ]
    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
  • Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO [ Time Frame: 12 weeks after the EOT (up to Week 36 or 60) ] [ Designated as safety issue: No ]
    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
  • Sustained virological response (SVR), defined as plasma HCV RNV undetectable at 24 week after end of treatment [ Time Frame: up to 72 weeks ] [ Designated as safety issue: No ]
  • SVR12, defined as plasma HCV RNA undetectable at 12 weeks after end of treatment [ Time Frame: up to 60 weeks ] [ Designated as safety issue: No ]
  • Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8 [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • ALT normalization, defined as ALT normal at 24 weeks after end of treatment [ Time Frame: up to 72 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial
Safety, Efficacy and Pharmacokinetics of BI 201335 NA in Patient With Genotype 1 Chronic Hepatitis C Virus Infection in Combination With Pegylated Interferon Alfa-2b and Ribavirin - Cohort 1 for Treatment-naive Patients: Randomised, Double-blind Part of BI 201335 NA for 12 or 24 Weeks - Cohort 2 for Treatment-experienced Patients: Open-label Part of BI 201335 NA for 24 Weeks
The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hepatitis C
  • Drug: BI 201335 high dose
    BI 201335 high dose with PegIFN/RBV
  • Drug: BI 201335 low dose
    BI 201335 low dose with PegIFN/RBV
  • Experimental: 1. BI 201335 low dose plus PegIFN/RBV
    low dose BI 201335 NA once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
    Intervention: Drug: BI 201335 low dose
  • Experimental: 2. BI 201335 high dose plus PegIFN/RBV
    high dose BI 201335 NA once daily for 12 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
    Intervention: Drug: BI 201335 high dose
  • Experimental: 3. BI 201335 high dose plus PegIFN/RBV
    high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients
    Intervention: Drug: BI 201335 high dose
  • Experimental: 4. BI 201335 high dose plus PegIFN/RBV
    high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 48 weeks in treatment-experienced (null responder, partial responder, breakthrough) patients
    Intervention: Drug: BI 201335 high dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:

    • positive anti-HCV antibodies or detected HCV RNA at least 6 months before screening; or,
    • liver biopsy consistent with chronic HCV infection.
  2. HCV genotype 1 infection confirmed by genotypic testing at screening
  3. (For Cohort 1 only) Therapy-naïve to interferon, pegylated interferon, and ribavirin (For Cohort 2 only) Confirmed prior virological failure (null response, partial response, breakthrough or relapse) with an approved dose of PegIFN alfa/RBV or IFN beta/RBV for at least 12 weeks and with an 8-week washout period before screening
  4. HCV RNA = 100,000 IU/mL at screening
  5. Documentation of a liver biopsy within 3 years or fibroscan within 6 months before randomization (Visit 2)
  6. Age 20 to 70 years
  7. Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to use one accepted method of birth control in addition to the use of a condom by their male partners.

    or Male patients who are infertile, who are without pregnant female partners or who consistently and correctly use condoms.

  8. Signed informed consent form before trial participation

Exclusion criteria:

  1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening,
  2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Steatosis diagnosed incidentally (e.g. by biopsy) without clinical relevance is not an exclusion criterion.
  3. HIV co-infection,
  4. Hepatitis B virus (HBV) infection based on presence of hepatitis B surface antigen (HBsAg),
  5. Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix),
  6. Active or, history of alcohol or illicit drug abuse within the past 12 months,
  7. A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient's ability to participate in this study,
  8. Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study,
  9. Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened,
  10. Received silymarin (milk thistle), glycyrrhizin (Stronger Neo-Minophagen C; SNMC), or Sho-saiko-to (SST) within 28 days prior to randomization (Visit 2) and throughout the treatment phase of this trial,
  11. (For Cohort 2 only) Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than (pegylated) interferon alfa, interferon beta or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,
  12. Known hypersensitivity to any ingredient of the study drugs,
  13. Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2),

Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.

Both
20 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01579474
1220.54
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP