Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial
3 juillet 2015 mis à jour par: 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
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
131
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Chuo-ku, Chiba, Japon
- 1220.54.08104 Boehringer Ingelheim Investigational Site
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Chuo-ku, Kobe, Hyogo, Japon
- 1220.54.08118 Boehringer Ingelheim Investigational Site
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Fukui, Fukui, Japon
- 1220.54.08108 Boehringer Ingelheim Investigational Site
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Gifu, Gifu, Japon
- 1220.54.08110 Boehringer Ingelheim Investigational Site
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Itabashi-ku, Tokyo, Japon
- 1220.54.08105 Boehringer Ingelheim Investigational Site
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Izunokuni, Shizuoka, Japon
- 1220.54.08112 Boehringer Ingelheim Investigational Site
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Kanazawa, Ishikawa, Japon
- 1220.54.08107 Boehringer Ingelheim Investigational Site
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Kita-gun, Kagawa, Japon
- 1220.54.08120 Boehringer Ingelheim Investigational Site
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Kofu, Yamanashi, Japon
- 1220.54.08109 Boehringer Ingelheim Investigational Site
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Kurume, Fukuoka, Japon
- 1220.54.08123 Boehringer Ingelheim Investigational Site
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Mtsuyama, Ehime, Japon
- 1220.54.08121 Boehringer Ingelheim Investigational Site
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Nagoya, Aichi, Japon
- 1220.54.08113 Boehringer Ingelheim Investigational Site
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Nishinomiya, Hyogo, Japon
- 1220.54.08117 Boehringer Ingelheim Investigational Site
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Ogaki, Gifu, Japon
- 1220.54.08111 Boehringer Ingelheim Investigational Site
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Oo mura, Nagasaki,, Japon
- 1220.54.08124 Boehringer Ingelheim Investigational Site
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Osaka, Osaka, Japon
- 1220.54.08115 Boehringer Ingelheim Investigational Site
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Osakasayama, Osaka, Japon
- 1220.54.08116 Boehringer Ingelheim Investigational Site
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Sapporo, Hokkaido, Japon
- 1220.54.08101 Boehringer Ingelheim Investigational Site
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Sendai, Miyagi, Japon
- 1220.54.08102 Boehringer Ingelheim Investigational Site
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Tanabe, Wakayama, Japon
- 1220.54.08119 Boehringer Ingelheim Investigational Site
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Toyama,Toyama, Japon
- 1220.54.08106 Boehringer Ingelheim Investigational Site
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Tsu, Mie, Japon
- 1220.54.08114 Boehringer Ingelheim Investigational Site
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Yahatanishi-ku, Kitakyusyu, Fukuoka, Japon
- 1220.54.08122 Boehringer Ingelheim Investigational Site
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Yamagata, Yamagata, Japon
- 1220.54.08125 Boehringer Ingelheim Investigational Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion criteria:
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
- 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
Exclusion criteria:
- 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,
- 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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
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BI 201335 low dose with PegIFN/RBV
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Expérimental: 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
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BI 201335 high dose with PegIFN/RBV
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Expérimental: 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
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BI 201335 high dose with PegIFN/RBV
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Expérimental: 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
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BI 201335 high dose with PegIFN/RBV
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Patients With Investigator Defined Drug-related Adverse Events
Délai: Up to 52 weeks
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Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
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Up to 52 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)
Délai: EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)
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Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration
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EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)
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Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)
Délai: EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)
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Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration
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EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)
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Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8
Délai: up to 8 weeks
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Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8
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up to 8 weeks
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Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
Délai: EOT (up to Week 24 or 48)
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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)
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Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
Délai: 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)
|
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Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
Délai: 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
Délai: 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)
|
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Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2012
Achèvement primaire (Réel)
1 décembre 2013
Achèvement de l'étude (Réel)
1 décembre 2013
Dates d'inscription aux études
Première soumission
12 avril 2012
Première soumission répondant aux critères de contrôle qualité
17 avril 2012
Première publication (Estimation)
18 avril 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
3 août 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 juillet 2015
Dernière vérification
1 juillet 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1220.54
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .