CClinicalTrials.gg
Sign In
CompletedNCT01579474Updated Aug 3, 2015Results posted

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

A Phase 3 interventional study of BI 201335 high dose and BI 201335 low dose in Hepatitis C, sponsored by Boehringer Ingelheim. Completed at 24 sites in Japan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-08-03.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
131
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hepatitis C
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 131 is above the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
131 participants (actual)

Study arms

  • 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

    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

    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

    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

    Drug: BI 201335 high dose

Interventions

  • DrugBI 201335 high dose

    BI 201335 high dose with PegIFN/RBV

  • DrugBI 201335 low dose

    BI 201335 low dose with PegIFN/RBV

  • DrugBI 201335 high dose

    BI 201335 high dose with PegIFN/RBV

  • DrugBI 201335 high dose

    BI 201335 high dose with PegIFN/RBV

06

What researchers measure

Primary outcomes

  1. Number of Patients With Investigator Defined Drug-related Adverse Events

    Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.

    Time frame: Up to 52 weeks

Secondary outcomes

  1. Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)

    Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration

    Time frame: EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)

  2. Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)

    Plasma HCV RNA level \<25 IU/mL (undetected) 24 weeks after the originally planned treatment duration

    Time frame: EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)

  3. Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8

    Plasma HCV RNA level \<25 IU/mL (detected or undetected) at Week 4 and HCV RNA \<25 IU/mL (undetected) at Week 8

    Time frame: up to 8 weeks

  4. Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES

    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

    Time frame: EOT (up to Week 24 or 48)

  5. Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO

    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

    Time frame: EOT (up to Week 24 or 48)

  6. Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES

    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

    Time frame: 12 weeks after the EOT (up to Week 36 or 60)

  7. Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO

    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

    Time frame: 12 weeks after the EOT (up to Week 36 or 60)

  8. Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES

    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

    Time frame: EOT (up to Week 24 or 48)

  9. Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO

    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

    Time frame: EOT (up to Week 24 or 48)

  10. Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES

    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

    Time frame: 12 weeks after the EOT (up to Week 36 or 60)

  11. Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO

    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

    Time frame: 12 weeks after the EOT (up to Week 36 or 60)

07

Results

Posted Aug 3, 2015

Participant flow

Participant flow — Overall Study
MilestoneFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IRelapser Patients - Cohort IIPartial Responder Patients - Cohort IINull Responder Patients - Cohort IIBreakthrough Patients - Cohort II
Started4443293102
Completed413027391
Not completed3132011
Withdrew: Adverse event1132001
Withdrew: Lack of efficacy100010
Withdrew: Withdrawal by subject100000

Outcome measures

PrimaryNumber of Patients With Investigator Defined Drug-related Adverse Events

Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.

Time frame:
Up to 52 weeks
Reported as:
Number · participants
Number of Patients With Investigator Defined Drug-related Adverse Events
participantsFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort II
Number of Patients With Investigator Defined Drug-related Adverse Events434344
SecondarySustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)

Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration

Time frame:
EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)
Reported as:
Number · percentage of participants
Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)
percentage of participantsFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IRelapser Patients - Cohort IIPartial Responder Patients - Cohort IINull Responder Patients - Cohort IIBreakthrough Patients - Cohort II
Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)86.4 (76.2 to 96.5)74.4 (61.4 to 87.5)86.2 (73.7 to 98.8)66.7 (13.3 to 100.0)40.0 (9.6 to 70.4)50.0 (0.0 to 100.0)
SecondarySustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)

Plasma HCV RNA level \<25 IU/mL (undetected) 24 weeks after the originally planned treatment duration

Time frame:
EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)
Reported as:
Number · percentage of participants
Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)
percentage of participantsFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IRelapser Patients - Cohort IIPartial Responder Patients - Cohort IINull Responder Patients - Cohort IIBreakthrough Patients - Cohort II
Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)86.4 (76.2 to 96.5)72.1 (58.7 to 85.5)86.2 (73.7 to 98.8)66.7 (13.3 to 100.0)40.0 (9.6 to 70.4)50.0 (0.0 to 100.0)
SecondaryEarly Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8

Plasma HCV RNA level \<25 IU/mL (detected or undetected) at Week 4 and HCV RNA \<25 IU/mL (undetected) at Week 8

Time frame:
up to 8 weeks
Reported as:
Number · percentage of participants
Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8
percentage of participantsFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IRelapser Patients - Cohort IIPartial Responder Patients - Cohort IINull Responder Patients - Cohort IIBreakthrough Patients - Cohort II
Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 897.793.096.6100.070.050.0
SecondaryAlanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Time frame:
EOT (up to Week 24 or 48)
Reported as:
Number · participants
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
participantsFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IRelapser Patients - Cohort IIPartial Responder Patients - Cohort IINull Responder Patients - Cohort IIBreakthrough Patients - Cohort II
SVR12=Yes383225241
SVR12=Yes, BL normal to EOT normal161817211
SVR12=Yes, BL elevated to EOT normal16107030
SVR12=Yes, no BL or EOT data available000000
SecondaryAlanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Time frame:
EOT (up to Week 24 or 48)
Reported as:
Number · participants
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
participantsFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IRelapser Patients - Cohort IIPartial Responder Patients - Cohort IINull Responder Patients - Cohort IIBreakthrough Patients - Cohort II
SVR12=No6114161
SVR12=No, BL normal to EOT normal463040
SVR12=No, BL elevated to EOT normal220121
SVR12=No, no BL or EOT data available000000
SecondaryAlanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Time frame:
12 weeks after the EOT (up to Week 36 or 60)
Reported as:
Number · participants
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
participantsFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IRelapser Patients - Cohort IIPartial Responder Patients - Cohort IINull Responder Patients - Cohort IIBreakthrough Patients - Cohort II
SVR12=Yes383225241
SVR12=Yes, BL normal to SVR12 normal171818211
SVR12=Yes, BL elevated to SVR12 normal19127030
SVR12=Yes, no BL or SVR12 data available010000
SecondaryAlanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Time frame:
12 weeks after the EOT (up to Week 36 or 60)
Reported as:
Number · participants
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
participantsFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IRelapser Patients - Cohort IIPartial Responder Patients - Cohort IINull Responder Patients - Cohort IIBreakthrough Patients - Cohort II
SVR12=No6114161
SVR12=No, BL normal to SVR12 normal242000
SVR12=No, BL elevated to SVR12 normal020110
SVR12=No, no BL or SVR12 data available141021
SecondaryAspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Time frame:
EOT (up to Week 24 or 48)
Reported as:
Number · participants
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
participantsFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IRelapser Patients - Cohort IIPartial Responder Patients - Cohort IINull Responder Patients - Cohort IIBreakthrough Patients - Cohort II
SVR12=Yes383225241
SVR12=Yes, BL normal to EOT normal211816211
SVR12=Yes, BL elevated to EOT normal1197030
SVR12=Yes, no BL or EOT data available000000
SecondaryAspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Time frame:
EOT (up to Week 24 or 48)
Reported as:
Number · participants
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
participantsFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IRelapser Patients - Cohort IIPartial Responder Patients - Cohort IINull Responder Patients - Cohort IIBreakthrough Patients - Cohort II
SVR12=No6114161
SVR12=No, BL normal to EOT normal462140
SVR12=No, BL elevated to EOT normal230021
SVR12=No, no BL or EOT data available000000
SecondaryAspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Time frame:
12 weeks after the EOT (up to Week 36 or 60)
Reported as:
Number · participants
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
participantsFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IRelapser Patients - Cohort IIPartial Responder Patients - Cohort IINull Responder Patients - Cohort IIBreakthrough Patients - Cohort II
SVR12=Yes383225241
SVR12=Yes, BL normal to SVR12 normal231818211
SVR12=Yes, BL elevated to SVR12 normal13127030
SVR12=Yes, no BL or SVR12 data available010000
SecondaryAspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO

This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline

Time frame:
12 weeks after the EOT (up to Week 36 or 60)
Reported as:
Number · participants
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
participantsFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IRelapser Patients - Cohort IIPartial Responder Patients - Cohort IINull Responder Patients - Cohort IIBreakthrough Patients - Cohort II
SVR12=No6114161
SVR12=No, BL normal to SVR12 normal231110
SVR12=No, BL elevated to SVR12 normal110000
SVR12=No, no BL or SVR12 data available141021

Adverse events

Collected over Up to 48 weeks + 30 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Faldaprevir 120 mg q.d - Cohort I—3/44 (6.8%)44/44 (100%)
Faldaprevir 240 mg q.d - Cohort I—4/43 (9.3%)43/43 (100%)
Faldaprevir 240 mg q.d - Cohort II—1/44 (2.3%)44/44 (100%)
Most frequent serious events
Most frequent serious events
EventFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort II
VertigoEar and labyrinth disorders0/441/430/44
NauseaGastrointestinal disorders1/441/430/44
VomitingGastrointestinal disorders0/441/430/44
MalaiseGeneral disorders0/441/430/44
Erythema multiformeSkin and subcutaneous tissue disorders0/441/430/44
RashSkin and subcutaneous tissue disorders0/441/430/44
ThrombocytopeniaBlood and lymphatic system disorders0/440/431/44
Mallory-Weiss syndromeGastrointestinal disorders1/440/430/44
Renal abscessInfections and infestations1/440/430/44
Most frequent other events
Showing 10 of 52
Most frequent other events
EventFaldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort II
PyrexiaGeneral disorders35/4433/4335/44
NauseaGastrointestinal disorders18/4424/4328/44
RashSkin and subcutaneous tissue disorders18/4426/4323/44
DiarrhoeaGastrointestinal disorders7/4419/4323/44
VomitingGastrointestinal disorders10/4420/4321/44
AlopeciaSkin and subcutaneous tissue disorders15/4414/4317/44
AnaemiaBlood and lymphatic system disorders12/4416/4313/44
Injection site reactionGeneral disorders13/4416/4310/44
Decreased appetiteMetabolism and nutrition disorders9/4416/4315/44
HeadacheNervous system disorders15/4413/4314/44

Baseline characteristics

FAS (All patients who were randomized and received at least 1 dose of the trial medication)

Age, Continuous
Age, Continuous(years)Faldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IRelapser Patients - Cohort IIPartial Responder Patients - Cohort IINull Responder Patients - Cohort IIBreakthrough Patients - Cohort IITotal
Mean53.5 ± 7.6156.6 ± 9.361.3 ± 6.7947.0 ± 18.0854.9 ± 9.5557.5 ± 14.8556.3 ± 8.97
Sex: Female, Male
Sex: Female, Male(Participants)Faldaprevir 120 mg q.d - Cohort IFaldaprevir 240 mg q.d - Cohort IRelapser Patients - Cohort IIPartial Responder Patients - Cohort IINull Responder Patients - Cohort IIBreakthrough Patients - Cohort IITotal
Female22271425272
Male22161515059
08

Study locations

24 sites
  • 1220.54.08104 Boehringer Ingelheim Investigational Site
    Chuo-ku, Chiba, Japan
  • 1220.54.08118 Boehringer Ingelheim Investigational Site
    Chuo-ku, Kobe, Hyogo, Japan
  • 1220.54.08108 Boehringer Ingelheim Investigational Site
    Fukui, Fukui, Japan
  • 1220.54.08110 Boehringer Ingelheim Investigational Site
    Gifu, Gifu, Japan
  • 1220.54.08105 Boehringer Ingelheim Investigational Site
    Itabashi-ku, Tokyo, Japan
  • 1220.54.08112 Boehringer Ingelheim Investigational Site
    Izunokuni, Shizuoka, Japan
  • 1220.54.08107 Boehringer Ingelheim Investigational Site
    Kanazawa, Ishikawa, Japan
  • 1220.54.08120 Boehringer Ingelheim Investigational Site
    Kita-gun, Kagawa, Japan
  • 1220.54.08109 Boehringer Ingelheim Investigational Site
    Kofu, Yamanashi, Japan
  • 1220.54.08123 Boehringer Ingelheim Investigational Site
    Kurume, Fukuoka, Japan
  • 1220.54.08121 Boehringer Ingelheim Investigational Site
    Mtsuyama, Ehime, Japan
  • 1220.54.08113 Boehringer Ingelheim Investigational Site
    Nagoya, Aichi, Japan
  • 1220.54.08117 Boehringer Ingelheim Investigational Site
    Nishinomiya, Hyogo, Japan
  • 1220.54.08111 Boehringer Ingelheim Investigational Site
    Ogaki, Gifu, Japan
  • 1220.54.08124 Boehringer Ingelheim Investigational Site
    Oo mura, Nagasaki,, Japan
  • 1220.54.08115 Boehringer Ingelheim Investigational Site
    Osaka, Osaka, Japan
  • 1220.54.08116 Boehringer Ingelheim Investigational Site
    Osakasayama, Osaka, Japan
  • 1220.54.08101 Boehringer Ingelheim Investigational Site
    Sapporo, Hokkaido, Japan
  • 1220.54.08102 Boehringer Ingelheim Investigational Site
    Sendai, Miyagi, Japan
  • 1220.54.08119 Boehringer Ingelheim Investigational Site
    Tanabe, Wakayama, Japan
  • 1220.54.08106 Boehringer Ingelheim Investigational Site
    Toyama,Toyama, Japan
  • 1220.54.08114 Boehringer Ingelheim Investigational Site
    Tsu, Mie, Japan
  • 1220.54.08122 Boehringer Ingelheim Investigational Site
    Yahatanishi-ku, Kitakyusyu, Fukuoka, Japan
  • 1220.54.08125 Boehringer Ingelheim Investigational Site
    Yamagata, Yamagata, Japan
09

References and documents

Publications

  • Nishiguchi S, Urano Y, Suzaki K, Taniguchi A, Scherer J, Berger KL, Quinson AM, Stern JO, Omata M. Safety and efficacy of faldaprevir in combination with pegylated interferon alpha-2b and ribavirin in Japanese patients with genotype-1 chronic hepatitis C virus infection. Hepatol Res. 2017 Mar;47(3):E142-E151. doi: 10.1111/hepr.12741. Epub 2016 Aug 10. PubMed 27153246 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01579474
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Apr 18, 2012
Start date
Apr 2012
Primary completion
Dec 2013
Completion
Dec 2013
Results posted
Aug 3, 2015
Last update
Aug 3, 2015

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hepatitis C→

Other studies from this sponsor

Boehringer Ingelheim

Start the discussion