- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01579474
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
-
-
-
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
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
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
|
BI 201335 low dose with PegIFN/RBV
|
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
|
BI 201335 high dose with PegIFN/RBV
|
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
|
BI 201335 high dose with PegIFN/RBV
|
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
|
BI 201335 high dose with PegIFN/RBV
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Patients With Investigator Defined Drug-related Adverse Events
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 1220.54
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Hepatitis C
-
Tripep ABInovio PharmaceuticalsUnbekanntChronische Hepatitis-C-VirusinfektionSchweden
-
Trek Therapeutics, PBCAbgeschlossenChronische Hepatitis C | Hepatitis-C-Genotyp 1 | Hepatitis C (HCV) | Hepatitis-C-VirusinfektionVereinigte Staaten, Neuseeland
-
Trek Therapeutics, PBCAbgeschlossenChronische Hepatitis C | Hepatitis C (HCV) | Hepatitis-C-Genotyp 4 | Hepatitis-C-VirusinfektionVereinigte Staaten
-
AbbVieAbgeschlossenHepatitis-C-Virus | Chronisches Hepatitis-C-Virus
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsZurückgezogenChronische Hepatitis-C-VirusinfektionIsrael
-
Hadassah Medical OrganizationUnbekanntChronische Hepatitis-C-VirusinfektionIsrael
-
ANRS, Emerging Infectious DiseasesUniversité Montpellier; Centre MurazAktiv, nicht rekrutierendChronische Hepatitis c | Hepatitis-C-Virusinfektion, Vergangenheit oder GegenwartBurkina Faso
-
Sohag UniversityRekrutierung
-
Beni-Suef UniversityAbgeschlossenChronische Hepatitis-C-VirusinfektionÄgypten
Klinische Studien zur BI 201335 low dose
-
Boehringer IngelheimAbgeschlossen
-
Boehringer IngelheimAbgeschlossen
-
Boehringer IngelheimAbgeschlossenAntivirale Wirkung, Sicherheit und Pharmakokinetik von BI201335 + PegIFN/RBV in HCV-GT1 (SILEN-C1&2)Hepatitis C, chronischVereinigte Staaten, Argentinien, Australien, Österreich, Kanada, Tschechische Republik, Frankreich, Deutschland, Korea, Republik von, Niederlande, Portugal, Rumänien, Spanien, Schweiz, Vereinigtes Königreich
-
Boehringer IngelheimAbgeschlossen
-
Boehringer IngelheimAbgeschlossenLeberzirrhose | Hepatitis CDeutschland
-
Boehringer IngelheimAbgeschlossen
-
Boehringer IngelheimAbgeschlossenHepatitis C, chronischVereinigte Staaten, Österreich, Kanada, Frankreich, Deutschland, Ungarn, Irland, Italien, Niederlande, Portugal, Rumänien, Russische Föderation, Spanien, Vereinigtes Königreich
-
Boehringer IngelheimAbgeschlossen
-
Boehringer IngelheimAbgeschlossen
-
Boehringer IngelheimAbgeschlossen