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

3. juli 2015 oppdatert av: Boehringer Ingelheim

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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

131

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: BI 201335 low dose
BI 201335 low dose with PegIFN/RBV
Eksperimentell: 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
Legemiddel: BI 201335 high dose
BI 201335 high dose with PegIFN/RBV
Eksperimentell: 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
Legemiddel: BI 201335 high dose
BI 201335 high dose with PegIFN/RBV
Eksperimentell: 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
Legemiddel: BI 201335 high dose
BI 201335 high dose with PegIFN/RBV

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Patients With Investigator Defined Drug-related Adverse Events
Tidsramme: Up to 52 weeks
Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Up to 52 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)
Tidsramme: EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)
Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration
EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)
Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)
Tidsramme: EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)
Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration
EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)
Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8
Tidsramme: up to 8 weeks
Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8
up to 8 weeks
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
Tidsramme: EOT (up to Week 24 or 48)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
EOT (up to Week 24 or 48)
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
Tidsramme: EOT (up to Week 24 or 48)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
EOT (up to Week 24 or 48)
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
Tidsramme: 12 weeks after the EOT (up to Week 36 or 60)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks after the EOT (up to Week 36 or 60)
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
Tidsramme: 12 weeks after the EOT (up to Week 36 or 60)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks after the EOT (up to Week 36 or 60)
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
Tidsramme: EOT (up to Week 24 or 48)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
EOT (up to Week 24 or 48)
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
Tidsramme: EOT (up to Week 24 or 48)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
EOT (up to Week 24 or 48)
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
Tidsramme: 12 weeks after the EOT (up to Week 36 or 60)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks after the EOT (up to Week 36 or 60)
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
Tidsramme: 12 weeks after the EOT (up to Week 36 or 60)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks after the EOT (up to Week 36 or 60)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2012

Primær fullføring (Faktiske)

1. desember 2013

Studiet fullført (Faktiske)

1. desember 2013

Datoer for studieregistrering

Først innsendt

12. april 2012

Først innsendt som oppfylte QC-kriteriene

17. april 2012

Først lagt ut (Anslag)

18. april 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

3. august 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juli 2015

Sist bekreftet

1. juli 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1220.54

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