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Hepatitis CPhase 3NCT01579474

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

A Phase 3 study testing BI 201335 high dose and BI 201335 low dose in people with Hepatitis C, run by Boehringer Ingelheim at 24 sites in Japan.

Completed

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

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Hepatitis C
What is being tested?
BI 201335 high dose and BI 201335 low dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
24 sitesJapan
Study dates
Apr 2012to Dec 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • HCV genotype 1 infection confirmed by genotypic testing at screening
  • (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
  • HCV RNA = 100,000 IU/mL at screening
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  • Documentation of a liver biopsy within 3 years or fibroscan within 6 months before randomization (Visit 2)
  • Age 20 to 70 years
  • 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.
  • Signed informed consent form before trial participation

Who cannot join

  • HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening,
  • 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.
  • HIV co-infection,
  • Hepatitis B virus (HBV) infection based on presence of hepatitis B surface antigen (HBsAg),
  • 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),
  • Active or, history of alcohol or illicit drug abuse within the past 12 months,
Show all 14Show fewer
  • 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,
  • Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study,
  • 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,
  • 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,
  • (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,
  • Known hypersensitivity to any ingredient of the study drugs,
  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Japan24 sites

  • 1220.54.08104 Boehringer Ingelheim Investigational Site

    Chuo-ku, Chiba

  • 1220.54.08118 Boehringer Ingelheim Investigational Site

    Chuo-ku, Kobe, Hyogo

  • 1220.54.08108 Boehringer Ingelheim Investigational Site

    Fukui, Fukui

  • 1220.54.08110 Boehringer Ingelheim Investigational Site

    Gifu, Gifu

  • 1220.54.08105 Boehringer Ingelheim Investigational Site

    Itabashi-ku, Tokyo

  • 1220.54.08112 Boehringer Ingelheim Investigational Site

    Izunokuni, Shizuoka

  • 1220.54.08107 Boehringer Ingelheim Investigational Site

    Kanazawa, Ishikawa

  • 1220.54.08120 Boehringer Ingelheim Investigational Site

    Kita-gun, Kagawa

  • 1220.54.08109 Boehringer Ingelheim Investigational Site

    Kofu, Yamanashi

  • 1220.54.08123 Boehringer Ingelheim Investigational Site

    Kurume, Fukuoka

  • 1220.54.08121 Boehringer Ingelheim Investigational Site

    Mtsuyama, Ehime

  • 1220.54.08113 Boehringer Ingelheim Investigational Site

    Nagoya, Aichi

  • 1220.54.08117 Boehringer Ingelheim Investigational Site

    Nishinomiya, Hyogo

  • 1220.54.08111 Boehringer Ingelheim Investigational Site

    Ogaki, Gifu

  • 1220.54.08124 Boehringer Ingelheim Investigational Site

    Oo Mura, Nagasaki,

  • 1220.54.08115 Boehringer Ingelheim Investigational Site

    Osaka, Osaka

  • 1220.54.08116 Boehringer Ingelheim Investigational Site

    Osakasayama, Osaka

  • 1220.54.08101 Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido

  • 1220.54.08102 Boehringer Ingelheim Investigational Site

    Sendai, Miyagi

  • 1220.54.08119 Boehringer Ingelheim Investigational Site

    Tanabe, Wakayama

  • 1220.54.08106 Boehringer Ingelheim Investigational Site

    Toyama,Toyama

  • 1220.54.08114 Boehringer Ingelheim Investigational Site

    Tsu, Mie

  • 1220.54.08122 Boehringer Ingelheim Investigational Site

    Yahatanishi-ku, Kitakyusyu, Fukuoka

  • 1220.54.08125 Boehringer Ingelheim Investigational Site

    Yamagata, Yamagata

Other trials in Japan

About this study

Official title: 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

Conditions
Hepatitis C
Being tested
BI 201335 high dose, BI 201335 low dose
Medical subject headings
Hepatitis C

What participants receive

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

  • BI 201335 high doseDrug

    BI 201335 high dose with PegIFN/RBV

  • BI 201335 low doseDrug

    BI 201335 low dose with PegIFN/RBV

  • BI 201335 high doseDrug

    BI 201335 high dose with PegIFN/RBV

  • BI 201335 high doseDrug

    BI 201335 high dose with PegIFN/RBV

Study groups in NCT01579474
Study groupRoleWhat they receive
1. BI 201335 low dose plus PegIFN/RBVExperimentallow dose BI 201335 NA once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
Receives: Drug: BI 201335 low dose
2. BI 201335 high dose plus PegIFN/RBVExperimentalhigh dose BI 201335 NA once daily for 12 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
Receives: Drug: BI 201335 high dose
3. BI 201335 high dose plus PegIFN/RBVExperimentalhigh dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients
Receives: Drug: BI 201335 high dose
4. BI 201335 high dose plus PegIFN/RBVExperimentalhigh 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
Receives: Drug: BI 201335 high dose

What is being measured

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

  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.

    Measured: Up to 52 weeks

Secondary outcomes (11)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

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

  1. First posted18 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01579474
Sponsor's protocol ID
1220.54
Status last verified
Jul 2015
First submitted
12 Apr 2012
Last updated
3 Aug 2015

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 201335 high dose and BI 201335 low dose in people with Hepatitis C, run by Boehringer Ingelheim at 24 sites in Japan.

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

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Number of Patients With Investigator Defined Drug-related Adverse Events (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01579474, which also lists 1 linked publication.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2015.

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